Clinical Digest: Recent Clinical Trials on Influenza
To assist researchers and healthcare practitioners in staying up-to-date with the latest advancements in clinical research, the Clinical Digest Team has compiled a comprehensive list of recent clinical trials related to Influenza. These trials are organized by their release dates for your convenience. (Last updated on: 2025-05-02)
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TABLE 1: Clinical Digest: Recent Clinical Trials on Influenza
| Clinical Trial | Contact(s) | Date | |
|---|---|---|---|
| 1 | Increasing Men’s Engagement in Preventive Healthcare Through An Enhanced Cocoon Vaccination Strategy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this clinical trial is to understand if offering a high touch engagement with healthcare center catered to men and bedside vaccine access in a birthing center increases men’s engagement in preventive healthcare. The main questions it aims to answer are: Does access to vaccinations and overall health education for men lead to increased uptake of vaccines? Does access to vaccinations and overall health education for men lead to increased engagement in overall healthcare of male identifying support persons. Researchers will compare three arms (one that receives an offer of vaccines at bedside in the birthing clinic, … |
RANDY VINCE; | 2025-05-01 |
| 2 | Investigation of Impact of Milk Consumption on H5 Influenza Detection in Respiratory Specimens PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to determine whether drinking pasteurized milk (milk heated to kill harmful germs) that contains inactive particles of a flu virus called A(H5) could lead to the detection of the virus in the nose or throat. Inactive particles are not capable of causing disease. The results will help the Centers for Disease Control and Prevention (CDC) better understand how milk consumption could affect flu surveillance. Investigators also want to see if the body produces antibodies in response to this milk consumption. |
DANIEL S. GRACIAA; | 2025-05-01 |
| 3 | Effect of Aquatic Exercises on Muscle Strength and Quality of Life in Children With Sickle Cell Anemia PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Sickle cell anemia is a global public health disorder that affects millions of people across the globe. It is an inherited autosomal recessive hemoglobin condition caused by a beta-globin gene mutation that results in an aberrant sickle cell hemoglobin molecule with glutamic acid replaced by valine at position six of the beta-globin chain. Sickle cell anemia is a hereditary illness characterized by persistent microvascular blockage by sickle-shaped cells, chronic hemolytic anemia, and tissue destruction. Red-cell dehydration, hypoxemia, metabolic acidosis, and hyperthermia are typical vaso-occlusive triggers. Children with sickle cell anemia frequently have poor growth and nutritional status, increased protein turnover, … |
EMAN SAMIR SHALTOUT; | 2025-05-01 |
| 4 | Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in The Emergency Department (RAPID-ARIED) Trial PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The RAPID-ARIED Trial is a pragmatic, single-centre, parallel group, open-label, randomised controlled trial to be conducted in the Accident and Emergency Department of Queen Mary Hospital in Hong Kong. The investigators aim to 1) to evaluate the clinical impact of the routine application of point-of-care polymerase chain reaction (PCR) testing for targeted respiratory pathogens in the emergency department (ED) for adult patients with acute respiratory infections (ARIs) on the hospital length of stay (LOS), antiviral and antibiotic use during influenza seasons or future waves of COVID-19; … |
LAM PUI KIN; | 2025-04-30 |
| 5 | Evaluation of The Diagnostic Performance of The DM-DIV (in Vitro Diagnostic Medical Device) TestNPass for The Diagnosis of SARS-CoV-2 Infection Using A Nasopharyngeal Sample PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The COVID-19 pandemic has created a major global health crisis that requires a rapid and effective response, particularly in the field of diagnostics. The first tests used, based on PCR (polymerase chain reaction) performed through a deep nasopharyngeal swab, have shown their limitations in controlling the epidemic. The current need is to develop new tests that are rapid, affordable and easy to use, and that can be used on a large scale in outpatient settings to reduce the burden on healthcare teams. In addition, … |
UNIVERSITY HOSPITAL GRENOBLE | 2025-04-30 |
| 6 | VRC 328: A Phase I Open-Label Clinical Trial to Evaluate The Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Vaccines help the body learn to fight infections. Some vaccines are combined with adjuvants, which are added substances that make vaccines work better. FluMos-v2 is an experimental flu vaccine; ALFQ is an experimental adjuvant. Objective: To test FluMos-v2, with and without the ALFQ adjuvant, … |
LASONJI A HOLMAN; | 2025-04-28 |
| 7 | Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Trial To Evaluate The Safety And Immunogenicity Of The Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) From Instituto Butantan, In Adults And The Older Adults PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to demonstrate the safety and immunogenicity of two formulations of the monovalent influenza vaccine candidate A (H5N8) (inactivated, fragmented, and adjuvanted with IB160) from the Instituto Butantan in adults and older adults, to be developed for situations of pandemic, epidemic or outbreak of avian type A/H5 in humans, in the context of pandemic preparedness. |
BUTANTAN INSTITUTE | 2025-04-23 |
| 8 | A Phase 1/2, Parallel-group, Randomized, Modified Double-blind, Placebo-controlled, Multi-center, Dose Ranging Study to Evaluate The Safety and Immunogenicity of A Second Generation Structurally Designed Pandemic Influenza H5 HA MRNA Vaccine in Healthy Adults Aged 18 Years and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this phase 1/2 study is to investigate the safety and immunogenicity of different doses (high, medium and low) of a second generation structurally designed (SD2) H5 messenger ribonucleic acid (mRNA) vaccine against pandemic H5 influenza virus (pandemic flu H5 hemagglutinin (HA) mRNA SD2) in healthy younger and older adults. The study will aim to identify the appropriate dose for further clinical development of a potential pandemic response vaccine. The study duration per participant will be approximately 13 months. There will be two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, … |
SANOFI | 2025-04-17 |
| 9 | Addressing The Problem of Recommended But Unfunded Vaccines Through A Transitional Stepped Co-payment Mechanism in Pharmacies PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this pilot demonstration and evaluation project is to increase the accessibility and uptake of recommended immunizations in the general public by implementing a transitional stepped co-payment model in community pharmacies in Nova Scotia and Ontario for the delivery of recommended but unfunded vaccines until full public funding is available. The main question it aims to answer is: * Can a transitional stepped co-payment model through pharmacies for the delivery of recommended but unfunded vaccines (e.g., Shingrix, … |
EMILY BLACK; | 2025-04-01 |
| 10 | Community-based Behavioral Intervention to Increase COVID-19 and Influenza Vaccination for African American/ Black and Latino Persons: An Optimization Randomized Controlled Trial Related Papers Related Patents Related Grants Related Experts View Highlight: The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Among those at highest risk for morbidity, hospitalization, and mortality are African American/Black and Latino (ABBL) persons who are not up-to-date on these vaccinations. Only 20-28% of adult AABL persons are up-to-date on COVID-19 vaccination, compared to 31% of White persons, … |
NEW YORK UNIVERSITY | 2025-04-01 |
| 11 | A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate The Safety and Immunogenicity of Different Formulations of Multivalent Influenza and Respiratory Syncytial Virus (RSV)/human Metapneumovirus (hMPV)/parainfluenza Virus Type 3 (PIV3) Vaccines in Healthy Participants 18 to 49 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study. Overall, … |
SANOFI | 2025-03-19 |
| 12 | Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France Related Papers Related Patents Related Grants Related Experts View Highlight: Hospital-Acquired Influenza (HAI) is closely linked to the intensity of influenza in the community. HAI is associated with significant morbidity, mortality and extra costs due to prolonged hospital stay. The incidence of laboratory confirmed HAI has been reported rarely. The proportion of HAI among influenza cases was 11.38% (95% Confidence Interval: 5.19%-19.55%) in a meta-analysis of 14 studies. In France, a prospective surveillance study of adults with Influenza-Like Illness (ILI) over 11 years, … |
HOSPICES CIVILS DE LYON | 2025-03-09 |
| 13 | A Phase 2, Randomized, Observer-blind, Active-control Study to Evaluate The Immunogenicity, Reactogenicity, and Safety of MRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age. |
MODERNATX | 2025-03-07 |
| 14 | Dissecting Human Immune Responses to Infection with Influenza or SARS-CoV-2 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the virus-specific immune response in people who are symptomatic with confirmed influenza or COVID-19. We will study the immune response of people who have and who have not been vaccinated with the seasonal influenza and COVID-19 vaccines within the past year. All participants will have data collected and blood, saliva, and nasal swabs performed at five separate visits; 1) at study enrollment, 2) on study day 7, 3) on or between study days 10 to 28, 4) on study day 90, … |
PHILIP MUDD; | 2025-03-07 |
| 15 | A Randomized, Blinded Phase I./II Clinical Trial to Evaluate The Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This clinical trial adopts a seamless design of phase I/II, conducted in two stages: phase I and phase II. Phase I is the age/dose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant，explore the immunogenicity of the vaccine, and determine the appropriate dose for later clinical trials of this product. |
FEI JIN; | 2025-03-01 |
| 16 | The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases in Live Attenuated Influenza Virus (LAIV) -induced nasal symptoms, and reduces mucosal antibody production. |
MEGHAN REBULI; | 2025-03-01 |
| 17 | A PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times. |
BIONTECH SE | 2025-02-10 |
| 18 | Influenza Human Challenge Model Using H3N2 (A/Texas/71/2017 (H3N2), Clade 3C3a) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is designed to help us better understand how the immune system responds to the flu and how flu is transmitted in the environment. The ultimate goal is to develop better vaccines and drugs to protect against or fight the flu. This study will describe how the body’s immune system responds to the flu virus during and after infection and how the flu virus is transmitted in the environment. The study will use a flu virus called A/Texas/71/2017 (H3N2), … |
NADINE ROUPHAEL; | 2025-02-04 |
| 19 | Pilot Study Enhancing Telemedicine Care Delivery for Adults With Complex Type 2 Diabetes PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is: Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible? Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes. Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, … |
MARGARET ZUPA; | 2025-02-03 |
| 20 | Effect of Oral Supplement Intervention on Influenza Vaccine Efficacy: A Randomized Controlled Clinical Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this clinical trial is to explore the efficacy of fatty acid and bile acid based supplements on enhancing influenza vaccine immune response in adults aged 60-70 years. The objectives of this study are: 1. To explore the efficacy of fatty acid and bile acid based supplements on enhancing flu vaccine immune response. 2. To evaluate the safety of fatty acid and bile acid use in elders. 3. To explore the potential role of microbiota in regulating immune response. This study will conduct a randomized clinical trial to compare the efficacy of fatty acid / bile acid (Tauro Ursodesoxy Cholic Acid, TUDCA)supplements on enhancing vaccine immune response. The antibody’s titer and safety indicators after influenza vaccination will be evaluated. Study process are: 1. Participants will be required to intake the assigned supplement or placebo daily for 25 days; 2. Receive a influenza vaccine on day 4; 3. Provide blood samples three times and stool samples twice at base line and endpoint respectively; 4. The antibody’s titer and safety indicators will be analyzed and compared among groups. This study aims to establish a theoretical foundation for utilizing nutritional strategies to enhance vaccine-induced immune responses and to provide a scientific framework for developing oral vaccine boosters. |
AI ZHAO; | 2025-02-01 |
| 21 | A Phase 3, Randomized, Observer-Blinded, Study to Compare The Safety and Immunogenicity of 3 Lots of SARS-CoV-2 RS Nanoparticle and Trivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix M™ Adjuvant in Participants ≥ 65 Years of Age Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches of a COVID-19 and Flu Combination Vaccine in Seniors Aged 65+ |
NOVAVAX | 2025-02-01 |
| 22 | Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Observational, prospective, multicenter cohort study with consecutive inclusion of COPD patients. Eligible patients will be those with severe and very severe COPD according to the GOLD 2024 (Global Initiative for Chronic Obstructive Lung Disease) guidelines being followed at participating hospitals. The severity of COPD is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. There is no national data on this subgroup. |
ASTRAZENECA | 2025-01-31 |
| 23 | Evaluating Immune Imprinting in The Context of Influenza Virus Infections PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Cellular and humoral immune responses in individuals with active influenza infection will be assessed. Each year, up to 50 participants will be enrolled. The investigators hypothesize that influenza infection will elicit mostly memory immune responses rather than de novo immune responses to infection. |
UNIVERSITY OF PENNSYLVANIA | 2025-01-27 |
| 24 | Analysis of Single Respiratory Viral Infections Versus Co-infections in The Post-pandemic Era: Prevalence and ICU Needs in Hospitalized Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of our study is to investigate the prevalence of viral respiratory infections in inpatients following the end of the pandemic. Additionally, the prevalence of patients co-infected with multiple viruses simultaneously will be assessed. In the secondary part of the study, the development of respiratory tract infections, the need for intensive care, and mortality rates within seven days will also be evaluated, and risk factors for patients with a more severe clinical course will be statistically calculated. |
ÖZLEM GÜLER; | 2025-01-12 |
| 25 | A Phase I/II, Randomized, Modified Double-blind Study to Investigate The Safety and Immunogenicity of Different Doses of Hexavalent Influenza MRNA HA + MRNA NA Vaccine in Adult Participants 50 Years of Age and Older PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older. |
SANOFI PASTEUR A SANOFI COMPANY | 2025-01-06 |
| 26 | Prospective Clinical Evaluation of COVID/Flu Detect™ Rapid Self-Test in Symptomatic Subjects for Non-Prescription Over-the-Counter (OTC) Use PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. Participants who are aged two (2) years and older and have symptoms of respiratory illness consistent with SARS-CoV-2 and influenza infection may be enrolled. Participants will use the COVID/Flu Detect™ Rapid Self-Test to self-collect, self-test, … |
INBIOS INTERNATIONAL | 2024-12-26 |
| 27 | A Clinical Trial Evaluating The Safety of An Aerosol BCG Controlled Human Infection Model in Assessing The Immunogenicity of Historical BCG Vaccination and Vaccination With ID93/GLA-SE in Healthy Adult Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to: 1. Demonstrate the safety of a novel TB vaccine (ID93/GLA-SE) when given to both BCG-vaccinated and BCG-naïve volunteers. 2. Provide preliminary immunogenicity data of this novel TB vaccine (ID93/GLA-SE). This clinical trial will apply an aerosol BCG challenge model involving 48 participants – 24 historically BCG-vaccinated volunteers and 24 BCG-naïve volunteers. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity. |
HELEN MCSHANE; | 2024-12-18 |
| 28 | A Randomized, Observer-Blinded, Active-Controlled Study to Evaluate The Safety and Immunogenicity of A COVID-19 Influenza Combination Nanoparticle Vaccine and A Standalone Trivalent Nanoparticle Influenza Hemagglutinin Vaccine in Participants ≥ 65 Years of Age PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a medical study where participants will be randomly assigned to receive either a new combination vaccine that protects against both COVID-19 and the flu, or a standard flu vaccine. The researchers conducting the study won’t know which vaccine each participant receives, ensuring their observations are unbiased. This study compares the new combination vaccine to an already available flu vaccine to see how well it works. It’s a large-scale, final-stage study designed to thoroughly check how well the vaccines trigger an immune response (immunogenicity) and how safe they are. |
NOVAVAX | 2024-12-09 |
| 29 | Characterization of The IFN-I Response in Subjects Who Experienced Severe or Mild Forms of COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Type I interferon (IFN-I) production is triggered by the detection of viral molecules, such as strands of viral RNA or DNA, by receptors known as PRRs (Pattern Recognition Receptors) present on many cell types. These interferons are secreted in minimal concentrations but can activate neighboring cells to secrete over 700 proteins with antiviral properties (inhibition of viral replication, destabilization of viral membranes, etc.). Thus, the IFN-I response serves as the immune system’s first line of defense during a viral infection. Very early in the COVID-19 pandemic, several research teams, including ours, … |
JEAN-CHRISTOPHE RICHARD; | 2024-12-02 |
| 30 | Acceptability, Usability and Preliminary Effectiveness of ChatGPT in Increasing Seasonal Influenza Vaccination Uptake Among Older Adults in Hong Kong PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: In this project, we will train a ChatGPT to provide real-time answers to questions related to the SIV for older adults in Hong Kong. This study aims to evaluate the usability, acceptability, and preliminary effectiveness of the ChatGPT among 50 community-living people aged 65 years and above in Hong Kong. The primary objectives are to evaluate the usability and acceptability (including the extent of usage and subjective experiences of behavioural, cognitive, and affective engagement) of the ChatGPT at the end of the 4-week intervention period (T1). The secondary objectives are to evaluate the following conditions measured at T1, … |
ZIXIN WANG; | 2024-12-01 |
| 31 | A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules |
GUANGDONG RAYNOVENT BIOTECH | 2024-11-30 |
| 32 | A Phase 1/2, Parallel, Randomized, Modified Double-blind, Multi-arm Study to Assess The Safety and Immunogenicity of A Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of A Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and High-dose Inactivated Influenza Vaccine in Adult Participants 50 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Study VBT00001 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of IIV-HD (high-dose inactivated influenza vaccine) + rC19 (adjuvanted recombinant COVID-19 vaccine) vaccine comprised of IIV-HD combined with different recombinant Spike (rS) antigen levels of rC19 compared to IIV-HD alone, rC19 (dose 1) alone, and IIV-HD and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the IIV-HD alone, rC19 (dose 1) alone, … |
SANOFI | 2024-11-19 |
| 33 | A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate The Immunogenicity, Reactogenicity, and Safety of MRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea). |
MODERNATX | 2024-11-18 |
| 34 | A Phase 1/2, Parallel, Randomized, Modified Double-blind, Multi-arm Study to Assess The Safety and Immunogenicity of A Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of A Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Study VBT00002 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinant Spike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the RIV alone, rC19 (dose 1) alone, … |
SANOFI | 2024-11-18 |
| 35 | Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Relapsing polychondritis (RP) is a rare, systemic autoimmune disorder characterized by episodic inflammation of cartilaginous structures. The goal of this clinical trial is to learn if drug Upadacitinib works to treat relapsing polychondritis in adults. It will also learn about the safety of drug Upadacitinib. The main questions it aims to answer are: * Does drug Upadacitinib reduce the disease activity of relapsing polychondritis? * What medical problems do participants have when taking drug Upadacitinib? Researchers will compare drug Upadacitinib to conventional therapies (treatment with corticosteroids combined with immunosuppressants) to see if drug Upadacitinib works to treat relapsing polychondritis. Participants will: * Take drug Upadacitinib or corticosteroids combined with immunosuppressants every day for 24 weeks. * Visit the hospital once every month for checkups and tests. This clinical study will explore the efficacy and immunological evaluation of Upadacitinib in the treatment of RP. |
HE JING; | 2024-11-15 |
| 36 | A Phase 3, Randomized, Modified Double-blind, 2-arm Study to Evaluate The Immunogenicity and Safety of High-Dose Inactivated Influenza Vaccine (IIV-HD) Compared With A Standard-dose Inactivated Influenza Vaccine (IIV-SD) in Participants 50 Through 64 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age. |
SANOFI PASTEUR A SANOFI COMPANY | 2024-11-04 |
| 37 | Pilot Sequential Multiple Assignment Randomized Trial for RSV Vaccine Uptake in Pregnancy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Central hypothesis: a multimodal approach is needed to enhance RSV vaccine uptake in pregnancy rather than the current standard of care that relies solely on physician recommendations at routine prenatal visits and/or mass messaging to the public. The investigators propose a pilot sequential multiple assignment randomized trial (SMART) to evaluate the effectiveness of a bundle of evidence-based and sequential strategies to test early (28-30 weeks gestation) and late (34-36 weeks gestation efficacy) to increase RSV vaccination during pregnancy. |
JEANNIE KELLY; | 2024-11-04 |
| 38 | A Phase 3, Randomized, Observer-Blinded, Study to Compare The Safety and Immunogenicity of 3 Lots of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine With Matrix M™ Adjuvant in Participants ≥ 60 Years of Age Related Papers Related Patents Related Grants Related Experts View Highlight: Phase 3 Study Comparing Safety and Immune Response of Three Batches of Novavax Flu Vaccine in older adult participants |
NOVAVAX | 2024-11-01 |
| 39 | A Multicenter, Randomized, Double-blind, Positive Controlled Phase Ⅲ Clinical Trial of ZX-7101A Tablets to Evaluate The Safety and Efficacy in The Treatment of Uncomplicated Influenza in Children Aged 5-11 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A multicenter, randomized, double-blind, positive controlled, phase III trial to evaluate the safety and efficacy of ZX-7101A tablets versus oseltamivir phosphate suspension in children aged ≥5 years and \< 12 years with uncomplicated influenza. |
HANMIN LIU; | 2024-10-31 |
| 40 | A Phase III, Randomized, Open-Label, Active-Controlled Study to Assess The Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Patients 1 to <12 Years of Age With Influenza Symptoms PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to \< 12 years with influenza symptoms. |
HOFFMANN LA ROCHE | 2024-10-27 |
| 41 | AI-enabled Vaccine Chatbot for Improving Influenza Vaccination Uptake in Children: A Cluster Randomized Trial PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to assess the impact of a vaccine chatbot on improving influenza vaccination uptake among children aged between 6 and 59 months through a cluster randomized trial. Specifically, the main questions it seeks to answer are whether an AI-enabled vaccine chatbot will increase the uptake of influenza vaccine among children and their family members, … |
ZHIYUAN HOU; | 2024-10-26 |
| 42 | Repeated Cross Sectional Surveillance Study To Determine The Influenza Vaccination Rates in German Participants During Current Respiratory Season PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: Real-time monitoring of vaccination rates for Germany is unavailable, and up-to-date data publication is delayed, which makes it challenging to develop effective public health strategies to increase vaccination coverage. This study aims to address the gap by assessing current influenza vaccination rates, particularly among those aged 60 and older, … |
SANOFI PASTEUR A SANOFI COMPANY | 2024-10-22 |
| 43 | Evaluation of A Multilevel Intervention on Adult COVID-19 and Influenza Vaccination Rate PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: The study will test two tactics to improve uptake of two vaccines in adults. The vaccines prevent COVID-19 and influenza. Both are common and harmful. Most adults do not get either vaccine. This is despite strong recommendations that all adults get both vaccines. The study will involve adult patients at eight Mayo Clinic primary care practices in Rochester and Kasson. The study will test the two tactics together. Four clinics will get the two tactics. The other four clinics will not. The study will randomly assign the two tactics to the clinics. One tactic is to send a letter by US mail to the patient. The letter will state strong recommendations on getting both vaccines now. It will tell patients how to get the vaccines now. The second tactic is to send monthly emails to clinicians. It will remind them to use every visit to vaccinate patients against COVID-19 and influenza. The study will compare the uptake of the two vaccines after six months in the clinics with and without the two tactics. |
LILA J. RUTTEN; | 2024-10-21 |
| 44 | Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease – Randomized Delayed-Start Pilot Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Observational and randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Beyond classical view of indirect effect, linked to the neutralisation of the virus, … |
UNIVERSITY HOSPITAL TOURS | 2024-10-21 |
| 45 | Influenza Vaccine Elicited Immune Response in Immunocompromised Patients PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to understand how well influenza vaccines work in some individuals with weakened immune systems compared to healthy individuals. Some people, such as those with HIV, multiple sclerosis, certain cancers, or autoimmune conditions, have more severe influenza disease courses due to their medical treatments. These individuals may also respond less effectively to vaccines. By comparing immune responses to the influenza vaccine in both immunocompromised patients and healthy participants, … |
CHRISTINE THURNHEER; | 2024-10-15 |
| 46 | Nationwide Utilization of Danish Government Electronic Letter System for Confirming The Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Adults with Chronic Disease PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. Conducted during the 2023/2024 influenza season, the first NUDGE-FLU-CHRONIC trial demonstrated the effectiveness of behavioral nudging letters in increasing influenza vaccination rates among adults aged 18-64 years with chronic diseases in Denmark. This present study will once again investigate whether digital behavioral nudges delivered via the official, … |
TOR BIERING-SØRENSEN; | 2024-10-01 |
| 47 | Text4Vax: Understanding The Effectiveness and Implementation of Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-2025 Season PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This multi-site study assesses the impact of text message reminders on the receipt of COVID-19 and influenza text message reminders takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network. |
MELISSA STOCKWELL; | 2024-10-01 |
| 48 | Effectiveness of Local Instillation of Antibiotics Compared to Systemic Antibiotics, As Adjunct to Ultrasound Guided Aspiration in The Management of Breast Abscess; A Randomized Controlled Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Breast abscess, marked by localized collection of pus, frequently follows mastitis. Its prevalence soars up to 16% in the developing world. It usually presents in lactating mothers but also develops in prepubertal females as well. Conventionally it has been treated by surgical incision and drainage with antibiotic coverage, whether oral, intramuscular or intravenous. This approach requires hospital stay and general anesthesia but also have complications like scarring and disfigurement. With the financial and emotional impacts of this technique , … |
ARSLAN ANWAR; | 2024-10-01 |
| 49 | Randomized, Double-blind, Multicenter, Phase III Clinical Trial Evaluating The Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Clinical trial with an active ingredient of a pharmaceutical specialty marketed in Spain vs. placebo. Randomized, double-blind, multicenter phase III clinical trial that evaluates the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza. |
INSTITUTO DE INVESTIGACIÓN SANITARIA Y BIOMÉDICA DE ALICANTE | 2024-10-01 |
| 50 | EbolaCov: A Phase IV, Single-centre, Single-blinded, Randomized Controlled Trial to Assess Safety and Immunogenicity of RVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrent With MRNA COVID-19 Vaccine Booster Doses in Healthy African Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Concurrent vaccination scheduling for key target populations in Rwanda, such as healthcare workers, may confer significant advantages in the provision of vaccine coverage to several infectious diseases. This is a phase IV vaccine trial that looks to establish if two licenced vaccines, the rVSVΔG-ZEBOV-GP vaccine for protection against Ebola virus and messenger ribonucleic acid (mRNA) COVID vaccine for protection against SARS-CoV-2 virus, given concurrently to self selected healthy adult volunteers confers an acceptable safety profile and immunogenicity response. |
CHRISTOPHER GREEN; | 2024-10-01 |
| 51 | A Multicenter, Open-label, Single-arm, Exploratory Clinical Study on The Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension in The Treatment of Uncomplicated Influenza in Pediatric and Adolescent Patients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to evaluate the tolerability, safety, pharmacokinetic characteristics and efficacy of a single oral dose of GP681 powder for oral suspension in pediatric and adolescent patients with uncomplicated influenza. The study will also explore the optimal dose for a confirmatory clinical trial. Eligible patients who have been confirmed influenza virus infection and have experienced influenza symptoms within 48 hours prior to enrollment, will receive single dose of GP681 powder for oral suspension. The primary outcome measures included the observation of adverse events during the study, the pharmacokinetic parameters, … |
JIANGXI QINGFENG PHARMACEUTICAL | 2024-09-27 |
| 52 | Comparison of High Vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2024-09-26 |
| 53 | Comparative Effects of Upper Extremity Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises on Thoracic Mobility in Children With Cerebral Palsy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Thoracic mobility is the mobility of the thoracic spine, and the rib cage is often measured by the degree of thorax expansion during breathing. Thoracic mobility is affected by many reasons, such as breathing mechanics, muscle stiffness, a sedentary lifestyle, … |
NAIMA KHALID; | 2024-09-26 |
| 54 | The Interaction Between Mucosal Microbiota Colonization in The Nasal Cavity and Gut and The Immune Response to An Intranasal Influenza Live Attenuated Vaccine in Children and Adolescents Aged 6 to 17 Years: A Single-Center, Randomized, Open-Label Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a single-center, randomized, open-label trial designed to explore the interaction between mucosal microbiota colonization in the nasal cavity and gut and the immune response to an intranasal live attenuated influenza vaccine (LAIV). The study plans to enroll 200 children and adolescents aged 6-17 years, with approximately 50% in the 6-11 years age group and 50% in the 12-17 years age group. Participants and their guardians must be able and willing to comply with the clinical trial protocol and provide informed consent. Eligible participants will be randomly assigned in a 1:1 ratio, stratified by age groups, … |
JING-XIN LI; | 2024-09-21 |
| 55 | A Phase 2b Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study to Evaluate Efficacy and Safety of CD388, A Novel Long-acting Antiviral Conjugate, for The Prevention of Influenza in Subjects Not at Risk for Influenza Complications PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the same, when administered as a single dose via 3 subcutaneous (SQ) injections to adult participants in stable health, and to evaluate the safety and tolerability of CD388, as compared to placebo. |
CIDARA THERAPEUTICS | 2024-09-20 |
| 56 | A Blinded, Randomized, Placebo-Controlled, Influenza Challenge Study in Healthy Adult Volunteers Using A Recombinant H3N2 (A/Texas/71/2017 (H3N2), Clade 3C3a) Influenza Challenge Virus PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The overall objective of the present study is to utilize the recombinant H3N2 (A/Texas/71/2017 (H3N2, clade 3C3a)) influenza virus for a controlled human infection model to study host responses to influenza virus with the aim of identifying volatile markers in exhaled breath and expression markers in saliva for early detection of infection after pathogen exposure. This study will aim to recruit up to 40 healthy volunteers between ages 18-45 who will receive a single dose of either intranasally administered placebo (sham inoculum) or the virus challenge strain at a concentration known to elicit a \~60-80% attack rate. The response to influenza challenge will be measured by clinical, laboratory, immunological, digital biomarker, on-breath volatile organic compound data and host RNA expression in both blood and saliva. The study will enroll and challenge up to 34 healthy adult volunteers with live virus plus approximately 6 sham-inoculated controls who will be prescreened for study inclusion to have serological antibody titers of ≤1:40 against the challenge strain. Each participant will complete up to 3 weeks of follow-up post confinement. |
DUKE UNIVERSITY | 2024-09-11 |
| 57 | An Exploratory Study to Establish The Dose, Safety and Pathogenicity of A New Influenza A H3N2 Challenge Strain in Healthy Participants 18 to 55 Years of Age PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: An Exploratory Study to Establish the Dose, Safety and Pathogenicity of a New Influenza A H3N2 Challenge Strain in Healthy Participants 18 to 55 Years of Age In Part A, up to 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2). Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose 2, or another virus dose (e.g., Virus Dose 3) |
ALEXANDRE LIMA; | 2024-09-11 |
| 58 | Measuring Immunity Against Circulating Influenza Viruses: Randomized Immunogenicity Study Among US Adults Aged 18-64 Years Comparing Two Approved Influenza Vaccines PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax) versus a licensed comparator influenza vaccine (Flublok or Fluzone). Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Participants will be asked if they wish to also provide saliva specimens at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), … |
EMMANUEL B WALTER; | 2024-09-09 |
| 59 | Influenza Reminder Text-Messaging: A Randomized Quality Improvement Effort to Promote Influenza Vaccine in Pediatric Primary Care PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: Through a large, population-level quality improvement effort within the Children’s Hospital of Philadelphia Care Network, we will evaluate text message reminders on flu vaccination rates for both patients with and without a scheduled well child care visit during flu season. |
BRIAN P. JENSSEN; | 2024-09-03 |
| 60 | A Prospective Randomized Trial of Personalized Nudges to Increase Influenza Vaccinations PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to prospectively test whether personalized, message-based nudges can increase flu vaccination compared with nudges that are not personalized or no nudges. |
CHRISTOPHER F CHABRIS; | 2024-09-01 |
| 61 | A Translational Phase I, Randomized, Parallel-group, Multi-arm Study to Evaluate Safety and Immunogenicity of An Influenza Vaccine Formulation Containing An Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Study FBP00005 is planned to be a translational Phase I, randomized, modified double-blind, active-controlled, multi-center study to be conducted in 2 stages in approximately 400 adults, 18 to 49 years of age and ≥ 60 years of age, in Australia. The purpose of the study is to evaluate the safety and immunogenicity of an influenza vaccine formulation composed of the WHO-recommended virus strains plus an additional H3 strain, … |
SANOFI PASTEUR A SANOFI COMPANY | 2024-08-12 |
| 62 | Phase I Clinical Study to Evaluate The Safety and Tolerability of A Monovalent Influenza A (H7N9) Vaccine Delivered Intradermally By High-density Microarray Patch (HD-MAP) in Healthy Adults Aged 18 to 50 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Study SP-1219-007 is a multi-centre, randomised, study designed to access the safety and tolerability of two doses of monovalent Influenza A (H7N9) vaccine delivered intradermally by a microarray patch delivery system in healthy adults aged 18 to 50 years. |
VAXXAS PTY | 2024-07-31 |
| 63 | A Phase 2, Randomized, Observer-blind Study to Evaluate The Safety, Reactogenicity, and Immunogenicity in Relation to The Product Attributes of MRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Adults ≥50 to <65 Years of Age PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age. |
MODERNATX | 2024-07-15 |
| 64 | Dime La VerDAD: Verify, Debunk, and Disseminate PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Dime La VerDAD is an innovative social media capacity-building program that empowers promotores de salud to debunk vaccine misinformation through the use of personal narratives on social media. The core of the implementation strategy consists of augmenting training and self-efficacy for natural community champions, promotores de salud from the Hispanic community as trusted messengers to debunk vaccination misinformation. The study will leverage existing community relationships in Chicago and a first of its kind misinformation curriculum to debunk misinformation in communities served by participating promotores de salud. Dime La VerDAD (Verify, Debunk, … |
MARINA DELRIOS; | 2024-07-02 |
| 65 | A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are: * safe; and * how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign. RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, … |
PFIZER | 2024-05-23 |
| 66 | A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate The Immunogenicity and Safety of MRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA). |
GLAXOSMITHKLINE | 2024-05-23 |
| 67 | Characterizing Late-season Influenza Vaccine Responses to Compare The 2023 and 2024 Vaccine Formulations PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Every 1-2 years, the seasonal influenza vaccine composition changes to include updated viruses, yet the precise effects of updating the vaccine remain understudied. Since the vaccine formulation for each season (with a season defined as starting in July and ending the following June) expires on June 30, vaccine formulations cannot be compared head-to-head. Thus, the 2023 and 2024 vaccines have only been compared by analyzing people given the former vaccine in the fall of 2023 and people given the latter vaccine in the fall of 2024, … |
TAL EINAV; | 2024-05-21 |
| 68 | A Multi-Site Clinical Evaluation of The LIAISON NES FLU A/B, RSV, & COVID-19 and LIAISON PLEX Respiratory (RSP) Flex Assays in Symptomatic Patients in Australia PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV & COVID-19 assay for viral nucleic acid targets from professionally collected or patient self-collected dry nasal (NS) swabs and to establish the relative accuracy of the LIAISON PLEX® RSP Flex assay from NS and nasopharyngeal swabs (NPS) in applicable transport media from human patients exhibiting clinical signs and symptoms of a respiratory tract infection. |
JANET FARHANG; | 2024-05-06 |
| 69 | Physician-Pharmacy Collaboration to Increase Patient Acceptance of Pneumococcal Immunization Prior to Inpatient Discharge PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this interventional clinical trial is to investigate the impact of medicine and pharmacy-led education on patient acceptance rates of Prevnar 20 pneumonia vaccination in patients eligible to receive the vaccine. The education intervention and subsequent option to get the vaccine will be done while the patient is admitted to inpatient care, … |
JASON WOLOSKI; | 2024-05-06 |
| 70 | Increasing The Feasibility, Impact, and Equity of The Medicare Annual Wellness Visit (AWV) PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this study is to improve the use of preventive health services by implementing a multilevel intervention to stimulate Annual Wellness Visit use in diverse practices across the United States. This is a stepped wedge cluster randomized controlled trial. The intervention will be implemented in a total of 24 primary care practices over 24 months. Every 3 months, … |
DERJUNG TARN; | 2024-05-01 |
| 71 | A Phase 1 Double-Blinded, Randomized, Placebo-Controlled Study Assessing Safety and Pharmacokinetics of Intramuscular SAB-176 (a Tc Bovine Derived Anti-Influenza Human Immunoglobulin) in Healthy Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the safety and tolerability of an intramuscular injection of SAB-176 intended for use as a pre/post prophylactic for influenza. This is a Phase 1, randomized, double-blind, … |
NEHKONTI ADAMS; | 2024-04-22 |
| 72 | A Binded, Randomised, Controlled Cross-over Trial to Assess The Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines. |
DIMITAR SAJKOV; | 2024-04-21 |
| 73 | A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate The Safety and Immunogenicity of The Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above. |
GUOHUA LI; | 2024-03-30 |
| 74 | A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of An Antiviral Mouth and Throat Rinse for The Treatment of Acute Sore Throat (Upper Respiratory Tract Infection E.g., Pharyngitis/Laryngitis) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo. |
ROMAN FISHCHUK; | 2024-03-25 |
| 75 | A Phase 3, Multicenter, Observer-blind, Randomized, Controlled Study to Evaluate The Immunogenicity, Reactogenicity, and Safety of A Self-Amplifying RNA COVID-19 Vaccine (ARCT-2303), Administered Concomitantly With Quadrivalent Influenza Vaccines, in Adults PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine. |
ARCTURUS THERAPEUTICS | 2024-03-01 |
| 76 | Immunogenicity to SARS-CoV-2 of Co-administering Bivalent MRNA BNT162b2 Booster and Quadrivalent Influenza Vaccine Among Healthy Volunteers: A Pilot Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study, a pilot randomized controlled trial, single-blind (outcome assessor), evaluating the immune response (both humoral and cell-mediated) against SARS-CoV-2 and the safety of three different vaccine administration approaches: the SARS-CoV-2 mRNA vaccine alone, the influenza vaccine alone, and the co-administration of both vaccines. |
SARUNYOU CHUSRI; | 2024-03-01 |
| 77 | Evaluation of Healthcare Workers Knowledge Regarding Their Vaccination Status and Their Relationship to Vaccination at Melun Hospital PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this observational study is to learn about the rate the of knowledge of own vaccination status among healthcare workers working at Groupe Hospitalier Sud Ile de France. The main question it aims to answer are : knowledge of own vaccination status is less than 50% among healthcare workers working at Groupe Hospitalier Sud Ile de France and the assessment of the relationship between healthcare workers of Groupe Hospitalier Sud Ile de France and vaccination in general. |
GROUPE HOSPITALIER SUD ILE DE FRANCE | 2024-02-28 |
| 78 | Revolutionizing Community-Acquired Pneumonia Diagnosis Through Integrating Novel Microbiological Techniques for Enhanced Precision PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate novel microbiological techniques for enhanced Pathogen Identification, assess the speed and efficiency of the integrated approach in providing timely diagnostic results, aiming to reduce the turnaround time for CAP diagnosis and subsequently improve patient outcomes and evaluate the clinical impact of enhanced precision in CAP diagnosis on treatment decisions, including the potential for targeted and more effective antimicrobial therapy based on accurate pathogen identification. |
AREEJ OSAMA ALI MOHAMMED SALEH; | 2024-02-25 |
| 79 | Low-value Care, and Variation in Practice for Children Hospitalized With Bronchiolitis – A Multicentric Prospective Observational Study PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Low-value care is defined as the use of a health service, such as diagnostics and treatments, for which the harms or costs outweigh the benefits. In pediatrics, investigations or treatments can be unpleasant or traumatizing to the child, can prolong the time spent in hospital, and can create a cascade of further futile investigations and treatments. Several of the commonly used diagnostics and treatments in bronchiolitis are considered low-value, … |
OLIVIER DROUIN; | 2024-02-13 |
| 80 | Predict + Protect: A Randomized Controlled Trial Exploring The Effectiveness of A Predictive Health Education Intervention on The Adoption of Protective Behaviors Related to Influenza-like Illness (ILI) PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this prospective, digital randomized controlled trial is to evaluate the effectiveness of a predictive ILI detection algorithm and associated alerts during influenza season for adults living in the contigent United States. The main study objectives are to assess the effectiveness of predictive ILI detection algorithm and associated alerts on protective behaviors related to ILI and assess the accuracy of a predictive ILI detection algorithm using participant self-reported ILI symptoms and diagnosis. |
ERNESTO H.N. RAMIREZ; | 2024-02-12 |
| 81 | Transmission Of Respiratory Tract MicroOrganisms In A School Environment – The TORTOISE-study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Through contact with peers in daycare and (primary)school young children play a large role in spreading respiratory pathogens. In this study the investigators will investigate this transmission, the subsequent colonization and infection dynamics, and their association with clinical symptoms and local immune response through dense minimally-invasive sampling. This study will allow us a unique insight into the transmission-, infection-, and colonization-potential of the respiratory pathogens. |
SIMON P JOCHEMS; | 2024-02-01 |
| 82 | A Phase 1/2 Randomized Study to Evaluate The Safety, Tolerability, and Immunogenicity of A Modified RNA COVID-19 Vaccine and A Recombinant Influenza Vaccine Administered As A Single Injection in Healthy Adults 50 Years of Age or Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this clinical trial is to see if combining a licensed COVID-19 vaccine and a licensed influenza vaccine into a single shot is safe and can help produce antibodies to defend the body against both SARS-CoV-2 (the virus that causes COVID-19) and influenza. Participants enrolled in this trial will be healthy adults, 50 years of age or older. |
PFIZER | 2024-01-31 |
| 83 | A Single-center, Observer-blind Study to Evaluate Safety, Immunogenicity, and Immunological Mechanisms of TETRALITE Influenza Vaccine With LiteVax Adjuvant, in Healthy Participants Aged 60 Years and Older and 18 to 50 Years PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics. |
LITEVAX BV | 2024-01-29 |
| 84 | Performance and Safety Assessment of HUMER STOP VIRUS Nasal Spray in Adults With Early Symptoms of Viral Respiratory Infection (COVID-19, Flu, Common Cold): An Open-label Randomized Controlled Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: There is no cure for cold or flu, most people recover in about within two weeks. Paracetamol may be used to reduce aches or treat fever, headache, … |
CAROLE PERRIN; | 2024-01-26 |
| 85 | Financial Incentives for Influenza Vaccination PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: In this work, we are assessing the impact of messaging with or without a $50 financial incentive on influenza vaccination rates in a county health system. Our main hypothesis is that a message with a $50 financial incentive will increase vaccination rates relative to a control/treatment as usual group. We further hypothesize that the financial incentive will increase vaccination rates relative to the message only arm. |
MIREILLE JACOBSON; | 2024-01-17 |
| 86 | Evaluation of A Screen and Treat Protocol for Influenza in Socially Vulnerable Communities PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study seeks to demonstrate that the laboratory can mitigate respiratory virus transmission in underserved populations by using laboratory data to identify communities at risk for increase vial activity (hot spots) and intervening with a test-to-treat model provides increased access to influenza diagnostics and treatment in vulnerable and underserved communities. |
MICHAEL CROSSEY; | 2024-01-15 |
| 87 | The Effectiveness of Adding Multiple Intermittent High-dose Inhalations of Nitric Oxide to Standard Antibacterial Therapy in The Treatment of Pneumonia PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a multicenter, prospective randomized controlled trial. At least 2 but no more than 5 centers are expected to participate in the study. The primary objective is to test the hypothesis that the addition of high-dose inhaled nitric oxide therapy to standard treatment has a positive effect on the clinical course of pneumonia and the structure and function of cardiopulmonary system. Number of participants: 200, including the subproject NO-PNEUMONIA-CAP – 100 CAP participants, the subproject NO-PNEUMONIA-NP – … |
TATIANA P. KALASHNIKOVA; | 2024-01-15 |
| 88 | Patient-Reported Outcomes Associated With COVID 19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Laboratory-Confirmed Illness in The United States PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to understand: – the symptoms of COVID-19 or influenza – health-related outcomes of people with COVID-19 or influenza – the effects of vaccines in people with COVID-19 or influenza. This study will take in participants who are: – 18 years or older – … |
PFIZER | 2024-01-08 |
| 89 | Efficacy of Physiological Saline and Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children Aged 2-5, in Son Tay Province, Hanoi PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Acute respiratory infections are common diseases worldwide with the highest incidence and mortality rates, especially among children. Currently, the prevention of acute respiratory infections in children still faces certain limitations. Although there is a vaccine available for influenza, there are no vaccines yet for RSV and adenovirus in children, and influenza vaccination needs to be repeated annually to achieve optimal effectiveness. Therefore, maintaining respiratory and throat hygiene is essential for both treatment and prevention, ensuring respiratory health for children and reducing the risk of bacterial co-infections. In recent years, preventive strategies for respiratory inflammation have garnered increasing attention, … |
THU TH NGUYEN; | 2024-01-02 |
| 90 | Wearable Assisted Viral Evidence (WAVE) Study A Decentralized, Prospective Study Exploring The Relationship Between Passively-collected Data From Wearable Activity Devices and Respiratory Viral Infections PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this decentralized, observational study is to enroll and observe adults in the contingent United States during the 2023-2024 flu season. The main study objectives are to create a dataset of paired wearable data, self-reported symptoms, and respiratory viral infection (RVI) from PCR testing during the 2023-2024 flu season and to develop algorithm that is able to accurately classify asymptomatic and symptomatic RVI and understand the algorithm’s performance metrics. |
ERNESTO RAMIREZ; | 2024-01-01 |
| 91 | A Prospective, Multicenter, Randomized Controlled Clinical Study on The Efficacy and Safety of Xuanfei Baidu Granule in The Treatment of Influenza A PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a prospective, multicenter, randomized controlled trial and aims to evaluate efficacy and safety of Xuanfei Baidu Granule in the treatment of influenza A. This study plans to enroll 584 subjects. The subjects will be randomly divided into 4 groups according to the ratio of 1:1:1:1, and they will be treated with Xuanfei Baidu Granule Placebo, Xuanfei Baidu Granule, Xuanfei Baidu Granule combined with Baloxavir Marboxil tablet.1 bag of Xuanfei Baidu Granule and Xuanfei Baidu Granule Placebo in the morning and evening, and take with boiling water for 5 days. Baloxavir Marboxil Tablet was taken orally 2 tablets, … |
ZHAOHUI TONG; | 2024-01-01 |
| 92 | Using A Telehealth Model to Address Vaccine Hesitancy and Increase Vaccine Completion Among Vulnerable Communities in Southeastern Louisiana PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a 24-30 month behavioral intervention study to assess the impact of enrolling individuals a clinical pharmacist run telehealth education focused on wellness and vaccination. Individuals will be randomized to either a wellness only model focusing on nutrition, diabetes and hypertension or a wellness model with a vaccination education component. All participants will complete individual and group based interventions. Individuals will be recruited from industries with high risk for COVID-19 and other respiratory illness infection, such as health workers, teachers aides and the food industry. We are recruiting individuals who identify as African-American, Hispanic, … |
SARA AL-DAHIR; | 2024-01-01 |
| 93 | A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 7500 participants will be assigned into 1 of 4 vaccination groups (Group A, B, … |
BIONTECH SE | 2023-12-21 |
| 94 | A Randomized, Double-blind, Parallel, Placebo-control Study to Evaluate The Efficacy and Safety of Formosa 1-Breath Free (NRICM101) in Subjects With The Symptoms of COVID-19 or Influenza-like PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Formosa 1-Breath Free (NRICM101) has been widely known in Taiwan to treat COVID-19. However, there is no phase III pivotal clinical trial of Formosa 1-Breath Free (NRICM101) . In order to obtain scientific, standardized, and comparable clinical results, … |
CHINA MEDICAL UNIVERSITY HOSPITAL | 2023-12-15 |
| 95 | A Feasibility Study of Xofluza Treatment of Influenza in Pediatric Transplant Recipients, Waitlisted Subjects and Household Members After Early Infection Alerting Using Wearable Devices PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this prospective, interventional, single-center study is to assess whether the early detection of Influenza with smart wearable device algorithms and alerting, rapid testing, and subsequent Baloxavir treatment demonstrate better post-infection outcomes versus publicly available- and Centers for Disease Control (CDC)-derived national statistics for equivalent household populations as well as pediatric kidney, heart, liver, lung transplant recipients and waitlisted patients. |
MATTHEW O CONNOR; | 2023-12-14 |
| 96 | A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate The Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter \[mL\]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India. |
GLAXOSMITHKLINE | 2023-12-14 |
| 97 | A PHASE 1, RANDOMIZED, OBSERVER-BLIND, DOSE-RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST PANDEMIC INFLUENZA IN HEALTHY ADULTS PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine. This study is seeking for participants who are: * between the ages of 18 to 49 years old or 65 to 84 years old. * willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, … |
PFIZER | 2023-12-13 |
| 98 | Randomized, Double-blind, Placebo-controlled Phase 2 Trial of ТВ/Flu-05Е Intranasal Vector Vaccine for The Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years |
TATYANA ZUBKOVA; | 2023-12-13 |
| 99 | Randomized, Double-blind, Placebo-controlled Phase 2 Trial of RSV/Flu-01E Vaccine for The Prevention of Respiratory Syncytial Virus Infection in Volunteers Over 60 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of the study is to investigate immunogenicity and safety of the RSV/Flu-01E intranasal vaccine for the prevention of respiratory syncytial virus infection in volunteers over 60 years |
TATYANA ZUBKOVA; | 2023-12-07 |
| 100 | Clinical Performance Study for EDAN’s COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of: 1. ClariLight Influenza A/B & SARS-CoV-2 test kits and 2. ClariLight Influenza A/B & RSV test kits, for the qualitative detection and differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) present in anterior nasal and oropharyngeal swab, in combination with an automated molecular diagnostic analyzer and sample collection tube by comparing them against a CE marked, in-vitro diagnostic device, used in the standard of care. |
EDAN INSTRUMENTS | 2023-12-01 |
| 101 | Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this randomized control trial is to assess if prenatal vaccine education and in-office vaccination administration for non-birthing partners of pregnant patients increases Tdap vaccination rates compared to usual care. The main question[s] it aims to answer are: – To assess whether compared to standard prenatal care, targeted prenatal education regarding Tdap vaccination recommendations with and without in office vaccination opportunities improves Tdap uptake among non-birthing partners of pregnant patients. – … |
LAURIE GRIFFIN; | 2023-12-01 |
| 102 | A Phase 1, First-in-Human, Randomized, Observer-blind, Controlled, Dose-ranging Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of A Self-Amplifying MRNA Seasonal Influenza Vaccine (ARCT-2138), When Administered to Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults. |
KRISTI MCLENDON; | 2023-12-01 |
| 103 | Clinical Evaluation of The Panbio™ COVID-19/Flu A&B Panel to Support Home Use PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subjects/lay-users who are symptomatic and suspected of viral respiratory infection. They will perform, read, and interpret the test result. The test is intended for nonprescription home use for qualitative detection of COVID-19, Influenza A antigen, and Influenza B antigen. |
ABBOTT RAPID DX | 2023-11-30 |
| 104 | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate The Efficacy and Safety in The Treatment of Uncomplicated Influenza in Adolescents PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents. The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents. |
NANJING ZENSHINE PHARMACEUTICALS | 2023-11-30 |
| 105 | Randomised, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate The Antiviral Activity Against Influenza Infection, Safety, Tolerability, and Pharmacokinetics of CC-42344 Via A Human Viral Challenge Model in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Participants in this study will be given either CC-42344 (one of two dose levels) or placebo orally for 5 days after receiving an influenza (flu) challenge virus. Participants will not know whether they are getting placebo or CC-42344. The amount of virus in nasal samples will be measured over time. Side effects and pharmacokinetics (the amount of CC-42344 in blood) will also be measured. |
VICTORIA PARKER; | 2023-11-25 |
| 106 | The Effectiveness of A Comprehensive Lung Health Promotion Program Based on The 5A Self-management Support Model for The Elderly in Nursing Home: A Randomized Controlled Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This research will be conducted to examine the effect of the lung health promotion program based on the 5A self-management support model on some physiological parameters, Physical Activity Scale in the Elderly score, sleep quality, health status perception and vaccination status of adults aged 65 and over. The research will be carried out as a randomized controlled study with a parallel design. We estimate that the respiratory functions of the elderly will improve, their physical activity levels will increase, … |
NURSEZA AKGÖZ; | 2023-11-24 |
| 107 | Clinical Validation of The Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, … |
QIN YANG; | 2023-11-20 |
| 108 | Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients. A Cohort Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents. The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response. |
ANDREA GRAU FREIXINET; | 2023-11-06 |
| 109 | The Immunogenicity and Safety of The Booster Doses of A Live-attenuated Mumps Vaccine Administrated Alone and Concomitantly With A Quadrivalent Inactivated Influenza Vaccine in Junior High School Students PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a randomized, controlled, open-label phase Ⅳ clinical trial of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the booster doses of a mumps vaccine administrated alone and concomitantly with a quadrivalent inactivated influenza vaccine in healthy junior high school students. And the cross-neutralization of mumps vaccine immune serum and mumps virus strains |
WEIJUN HU; | 2023-11-04 |
| 110 | A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of A MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc) in Comparison With Quadrivalent Influenza Vaccines, in Adults Aged 50 Years and Older PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIV1, … |
SEQIRUS | 2023-11-03 |
| 111 | Improving Vaccine Counseling Skills Among Pediatric, Medicine/Pediatric and Family Medicine Residents Pilot Study: Evaluation, Education, and Promotion of Vaccine Confidence Using Educational Modules and Standardized Patient Encounters PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Unfortunately, only 40% of US pediatric residency programs reported in a survey that vaccine safety and counseling training is provided to residents. The success of a residency curriculum focused on communication strategies with patients hesitant to receive the influenza vaccine has been demonstrated, finding a decreased rate of vaccination refusal in the post curricular period. In a recent 2020 study, … |
ANDREA HERNANDEZ-TROYA; | 2023-11-01 |
| 112 | Impact on Influenza Vaccination Rates of A Telephone Text Message Recall From The Attending Physician – A Cluster Randomized, Controlled and Pragmatic Trial PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a clinical trial designed to assess the impact on influenza vaccination rates among people aged over 65 of a telephone text message recalling them to be vaccinated by their GP. Twenty-two GPs will be randomly selected in each arm (recall versus usual care, 1:1). Each GP will include a maximum of 210 patients by random selection from their patient list. A difference of 4 percentage points is expected between the two arms at the end vaccination campaign in the vaccination rate. |
LAURENT RIGAL; | 2023-10-30 |
| 113 | A Randomized, Triple-blinded, Placebo-controlled, Parallel Group Study, to Assess The Effect of Multistrain Probiotic on The Immune Response to The Influenza Vaccination PF:3 Related Papers Related Patents Related Grants Related Experts View Abstract: Change in serum strain-specific geometric mean antibody titers (determined by hemagglutination inhibition \[HAI\] tests) specific for each of the 3 (out of the 4) virus strains … |
THE ARCHER DANIELS MIDLAND COMPANY | 2023-10-27 |
| 114 | Study of The Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Immune response to influenza vaccine in kidney transplant patients |
GOSSET CLÉMENT; | 2023-10-26 |
| 115 | A Phase 3 Randomized Double-blind Controlled Study to Evaluate The Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone. |
JANSSEN RESEARCH & DEVELOPMENT | 2023-10-24 |
| 116 | A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate The Efficacy, Safety and Immunogenicity of An MF59-Adjuvanted Subunit Inactivated Influenza Vaccine Compared to A Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age. The aim of the study is to evaluate MF59-adjuvanted influenza vaccine compared with non-adjuvanted influenza vaccine in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age. |
SEQIRUS | 2023-10-23 |
| 117 | Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want to use them to learn how respiratory viruses affect people in different ways. Objective: To use digital devices to collect data from participants in challenge studies that could indicate subtle changes in health during an infection that might otherwise go unnoticed. Eligibility: Healthy adults who have enrolled, were recently enrolled, … |
LUCA T GIURGEA; | 2023-10-23 |
| 118 | Dose-Escalation Study of A Low Pathogenicity Avian H10N7 Influenza Virus in A Healthy Human Challenge Model PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Influenza, also called flu, is a virus. It can cause mild symptoms such as fever, cough, sore throat, and aches. Sometimes, flu can cause serious complications. Researchers want to see how people s immune systems respond to the flu. Objective: To find the smallest dose of influenza H10N7 virus that may cause an uncomplicated mild to moderate flu infection in healthy people. This dose will be used in the future to test how well new flu vaccines work. Eligibility: Healthy adults age 18-50. Design: Participants will be screened with: Physical exam with vital signs and weight Medical and medicine review Blood and urine tests Electrocardiogram to measure the heart s electrical activity. Screening tests will be repeated during the study. Participants will be tested for SARS-CoV-2 and other respiratory infections. For this, a swab will be inserted into the back of the nose. Participants will be admitted to an isolation room in the Clinical Center. They will stay in the hospital for at least 10 days. They will not have visitors. Participants may have a heart ultrasound. They may have lung function tests. For this, they will blow into a tube to measure lung capacity. One dose of the flu virus will be sprayed into participants nostrils. Participants will be monitored 24 hours a day. They will give nasal samples (using nasal washes and brushes) and blood samples almost every day. They will complete surveys about their symptoms. Participants will be discharged after they have 2 consecutive negative tests for flu. Participants will have at least 4 follow-up visits: 1 visit every 2 weeks for 8 weeks. |
MATTHEW J MEMOLI; | 2023-10-23 |
| 119 | A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to <65 years of age (Cohort B). |
MODERNATX | 2023-10-19 |
| 120 | Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy Study: Randomized Trial to Compare The Clinical Efficacy of Novavax Vs. MRNA COVID-19 2023-2024 Updated Vaccines Among Adults 18-49 and 50+ Years in The United States PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this research study is to find out how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus), and to determine if getting a 2023-2024 updated vaccine provides better protection from COVID-19 than not getting a vaccine. If the participant chooses to get a 2023-2024 updated COVID-19 vaccine as part of this study, they will have a 50/50 chance of receiving either the Novavax or Pfizer mRNA vaccine. If the participant decides not to get a 2023-2024 updated COVID-19 vaccine, … |
SARANG K. YOON; | 2023-10-16 |
| 121 | An Exploratory Study To Establish The Dose, Safety, And Pathogenicity Of A New Influenza B Challenge Strain In Healthy Participants 18 To 55 Years Of Age PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age. |
VICTORIA PARKER; | 2023-10-03 |
| 122 | Improving Influenza Vaccination Delivery Across A Health System By The Electronic Health Records Patient Portal RCT 6 PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial is taking place in Los Angeles, CA at 21 clinics within the UCLA Health System. The study design is a 3 arm randomized trial. Patients will be randomized into 1) receiving portal based reminder messages with a video from their PCP encouraging them to receive the influenza vaccine, 2) portal-based reminder messages with an infographic with the image of their PCP encouraging them to receive the influenza vaccine, … |
PETER G SZILAGYI; | 2023-10-02 |
| 123 | CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness. The main question it aims to answer are: • the study is to validate that the device intended use in terms that the device’s performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver. |
BAEBIES | 2023-10-02 |
| 124 | Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High Dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During The Influenza Season 2023/24 PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This EPSS will determine the vaccinee reporting rates (RRs) of suspected ADRs following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the NH influenza season 2023/24. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) of suspected adverse drug reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the Northern Hemisphere (NH) influenza season 2023/24. Study duration per participant 2 months (including 6 weeks for VC distribution 2 weeks for vaccinee reporting) following the first vaccination |
SANOFI | 2023-10-02 |
| 125 | Do Evidence-based Fact Boxes Improve Informed Decision-making About COVID-19 and Influenza Vaccination in More and Less Disadvantaged Groups Equally? – Study Protocol for A Multi-center Cluster RCT in Health and Social Care in Germany PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The study aims to evaluate whether evidence-based fact boxes on COVID-19 and influenza vaccination contribute to the decision making of laypeople from different social backgrounds in different educational settings (e.g. medical practices, outreach work). Furthermore, the study will investigate whether evidence-based fact boxes can contribute to more equitable health care by improving shared decision-making. |
FELIX G. REBITSCHEK; | 2023-10-01 |
| 126 | Phase 1, Randomized, Placebo-Controlled, Observer Blind Study to Evaluate The Safety, Reactogenicity and Immunogenicity of An Investigational Self-Amplifying MRNA Influenza Vaccine in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of one or two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults. Approximately 128 evaluable subjects will be enrolled in this study; n=96 receiving investigational vaccine and n=32 receiving placebo. The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202). |
SEQIRUS | 2023-09-28 |
| 127 | A Phase 3, Randomized, Observer-Blind Study to Evaluate Safety, Tolerability, and Immunogenicity of MRNA-1345, An MRNA Vaccine Targeting Respiratory Syncytial Virus, When Coadministered With A High-Dose, Quadrivalent Seasonal Influenza Vaccine in Adults ≥65 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains. |
MODERNATX | 2023-09-25 |
| 128 | Immunogenicity of Concomitant Administration of Omicron-containing COVID-19 Vaccines With Influenza Vaccines : In-depth Immunogenicity Analysis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal is to evaluate the in-depth immunogenicity analysis (including B-cell and T-cell response) of coadministration of a omicron-containing COVID-19 vaccine and influenza vaccine among healthy adults during 2023-24 season. |
MIN JOO CHOI; | 2023-09-25 |
| 129 | Multi-center, Randomized, Double-blind, Placebo-controlled Trial of A Live Attenuated Influenza Vaccine in People Aged 3-17 PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine. To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine. |
CHANGCHUN BCHT BIOTECHNOLOGY | 2023-09-22 |
| 130 | An Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate The Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35months PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine. |
LEI WANG; | 2023-09-16 |
| 131 | A Randomized, Blinded, Comparable Vaccine-controlled Phase IIIb Clinical Trial to Evaluate The Safety and Immunogenicity of Meningococcal Polysaccharide Conjugate Vaccine, Group ACYW135 (CRM197 Vector), in A 4 to 6 Year-old Population PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous membranes of the human nasopharynx or causes local infection and can cross the mucosal barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can often cause serious disease epidemics worldwide, the main clinical features of its infection are fever, rash and meningitis, the most common clinical manifestation is acute bacterial meningitis. |
CANSINO BIOLOGICS | 2023-09-16 |
| 132 | Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake Among Adults With Chronic Disease PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. This study will investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among adults aged 18-64 years with chronic diseases. |
TOR BIERING-SØRENSEN; | 2023-09-15 |
| 133 | Nationwide Utilization of Danish Government Electronic Letter System for Confirming The Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. Conducted during the 2022/2023 influenza season, the first NUDGE-FLU trial demonstrated the effectiveness of two electronic behavioral nudging letter strategies in increasing influenza vaccination rates among older adults in Denmark – … |
TOR BIERING-SØRENSEN; | 2023-09-15 |
| 134 | Randomized Study of The Immunogenicity and Duration of Antibody Response Against Circulating SARS-CoV-2 Variant and Influenza Viruses Following Concomitant Versus Sequential Administration of MRNA COVID-19 Vaccine and Quadrivalent Cell Culture-based Influenza Vaccine Among Children and Adults PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites. |
MICHAEL WHITE; | 2023-09-15 |
| 135 | Study on The Impact of Coordinated Immunizations Against RSV and Influenza on The Prognosis in Patients With Chronic Heart Failure PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of patients with chronic heart failure. The main question it aims to answer is: • Does coordinated care through vaccinations improve the prognosis of patients with chronic heart failure? |
JAN BIEGUS; | 2023-09-15 |
| 136 | Double-blind Placebo-controlled Randomized Trial of Efficacy and Safety of Cycloferon, Enteric-coated Tablets, 150 Mg, for Post-exposure Prophylaxis of Acute Respiratory Viral Infection and Influenza PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Influenza and other acute respiratory viral infections remain practically uncontrollable diseases due to the high variability of the antigenic structure of influenza viruses and the heterogeneity of pathogens of acute respiratory infections. Therefore, for the prevention and treatment of influenza, acute respiratory viral infections and herpes infections, it is relevant to develop drugs – immunomodulators that mobilize the reserves of nonspecific and specific immune systems and enhance the effects of these systems against the pathogens. The drug CYCLOFERON, 150 mg, enteric-coated tablets, contains the active substance meglumine acridone acetate, … |
POLYSAN SCIENTIFIC & TECHNOLOGICAL PHARMACEUTICAL COMPANY | 2023-09-15 |
| 137 | Mushboost: Evaluating The Effect of Agaricus Bisporus Powder Intake on The Vaccination Response to An Influenza Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: There are numerous in vitro and animal studies that suggested that mushrooms beneficially influence the immune system. We have recently shown that a wild isolate of the edible Agaricus bisporus mushroom had a clear effect on parameters reflecting a better function of the immune system, both in vitro and in vivo in animals. The question now is whether this efficacy can also be translated to humans. In humans, measuring the antibody response is the golden standard to evaluate immune function. If Agaricus bisporus powder indeed has beneficial effects on the immune system, … |
MAASTRICHT UNIVERSITY MEDICAL CENTER | 2023-09-14 |
| 138 | Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women with NILM, ASC-US, LSIL or Low-grade CIN PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1). |
BLUESKY IMMUNOTHERAPIES | 2023-09-12 |
| 139 | Effect of Health Education on Promoting Influenza Vaccination Health Literacy Among Primary School Students PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China. Individuals aged 7 to 12 years who are in grades 4-5 in primary schools in Dongguan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a monthly health education intervention focused on influenza vaccination for 5 months, … |
LIN XU; | 2023-09-11 |
| 140 | A Phase II, Randomized, Double-blind, Multi-centre Trial to Evaluate The Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19. In this study approximately 300 adults aged 65 or older will be enrolled and followed for 1 month after study treatment. Safety and immunogenicity of all participants will be assessed. |
HIPRA SCIENTIFIC S L U | 2023-09-04 |
| 141 | Determining The Relationship Between Gut Microbiota and Immune Response to Influenza Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the effect of the microorganisms in the gut on how well the flu vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for 1 month. |
FREDDY CALDERA; | 2023-09-01 |
| 142 | A Comparative Evaluation of Specimen Adequacy of A Traditional Nasopharyngeal Swab As Compared to Nasopharyngeal Saline Wash, Saliva, and Serum to Test for Respiratory Viruses and Antibody Response PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Respiratory tract infections (RTIs) are prevalence community diseases and is the third leading cause of death worldwide. Rapid diagnosis of RTIs is essential as it drives decision points such as treatment, disposition, and containment. According to recent CDC (The Centers for Disease Control and Prevention) updates, nasopharyngeal swabbing is the preferred method of specimen collection for most RTIs such as SARS-COV-2. This process is invasive and traumatizing for patients as it requires probing (20 seconds) of the posterior nasopharynx with swab applicator. In some cases, … |
THANH NGUYEN; | 2023-08-21 |
| 143 | VRC 326 (001614): A Phase I Open-Label Clinical Trial to Evaluate The Safety, Tolerability, and Immunogenicity of A Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths per year worldwide. Current vaccines work well against single strains of flu virus. But no single vaccine works well against all flu viruses that can cause illness. Objective: To test an experimental flu vaccine (FluMos-v2) in healthy adults. Eligibility: Healthy adults aged 18 to 50 years. Design: Participants will have 11 clinic visits in 10 months. They must agree not to get a licensed flu vaccine while taking part in this study. FluMos-v2 will be given with a needle injected into a muscle in the upper arm. Participants will receive a follow-up phone call the following day. Participants will be given a diary card, a ruler, and a thermometer. They will take their temperature every day for 7 days after receiving the shot. They will measure any skin changes at the injection site. They will record their findings and how they feel. Participants will receive a second FluMos-v2 shot after 4 months. They will repeat the other follow-up steps. Participants will have 9 other clinic follow-up visits. Blood will be drawn at each visit. Participants should also come to the clinic if they develop flu-like symptoms during the study. Participants may opt for an apheresis 2 weeks after each shot: Blood will be removed through a needle in the vein of 1 arm. The blood will run through a machine that separates out the white blood cells. The remaining blood is returned through a needle in the other arm. |
LASONJI A HOLMAN; | 2023-08-09 |
| 144 | A Single-blind (Patient-blind), Randomized, Placebo-controlled, Intranasal Administration Study on Mechanisms and Potential Efficacy of AD17002 in Subjects With Poorly Controlled, Moderate to Severe Eosinophilic Asthma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this clinical trial is to investigate patients who have poorly controlled, moderate to severe eosinophilic asthma. The main questions it aims to answer are Could the LTh(αK) intranasal treatment improve the clinical condition of these patients? Could patients self-administrate LTh(αK) via the intranasal route? Is the LTh(αK) at multiple doses safe for asthmatic patients? Participants will be asked to self-administrate two doses per week for a total of 6 weeks and a diary on the usage of LTh(αK), adverse event, and reliever medication used will be recorded. |
ADVAGENE BIOPHARMA | 2023-08-07 |
| 145 | A Phase I/II Observer-blind, Randomized, Multi-center Trial to Evaluate The Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System (Referred to As Q-Pan H5N8), Given As A Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (\>=)18 years of age. |
GLAXOSMITHKLINE | 2023-08-03 |
| 146 | Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included. |
LAUREN FONTANA; | 2023-08-01 |
| 147 | UCLA Health Patient Health Maintenance Text Reminder July 2023 PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text message reminders impact patient engagement with primary care. This prospective randomized control trial is being implemented in conjunction with UCLA Health’s larger quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order to improve primary care preventive measure completion rates. |
RICHARD K. LEUCHTER; | 2023-07-27 |
| 148 | A Phase 1, Comparator-Controlled, Dosage-Escalation Study to Evaluate The Safety and Immunogenicity of Two Doses of DCVC H1 HA MRNA-LNP in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1, comparator-controlled, dosage escalation study of an intramuscularly administered mRNA-LNP vaccine, DCVC H1 HA mRNA Vaccine, encoding full-length H1 HA of influenza A/California/07/2009 (H1N1), in up to 50 adult volunteers aged 18 to 49 years, designed to assess vaccine safety and immunogenicity at varying doses. Eligible participants will be sequentially enrolled into dosing groups (10 mcg, 25 mcg, 50 mcg, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2023-07-20 |
| 149 | An Open Label, Dose Escalation Phase I Trial to Assess Safety and Immunogenicity of The H7HLAII DNA Vaccine, Encoding Influenza Hemagglutinin H7 Directed to HLA Class II, for Prophylaxis of Pandemic Influenza Infection in Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess safety and immunogenicity of H7HLAII, a DNA vaccine encoding influenza hemagglutinin (HA) from influenza A/Shanghai/2/2013 (H7N9) directed to cells expressing human leukocyte antigen class II (HLAII) molecules, for prophylaxis of pandemic H7N9 influenza infection in healthy volunteers. |
GUNNVEIG GRØDELAND; | 2023-07-15 |
| 150 | Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG). |
MODERNATX | 2023-07-10 |
| 151 | Analysis of Volatile Organic Compounds in Expired Air in Healthy Volunteers: Comparison of Three Mass Spectrometry Techniques for The Characterization of Volatolome in Clinical Studies PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A major obstacle in precision medicine is the unavailability of biomarkers that are easy to access, non-invasive, measurable with high-performance techniques, fast, easy to use, reproducible, inexpensive and easily deployable on a large scale. The analysis of exhaled air (volatolomics) is an omics approach devoted to the analysis of volatile organic compounds (VOCs) eliminated by the pulmonary route with real-time detection, at the patient’s bedside. The reference technology for the analysis of VOCs is mass spectrometry (MS). Several types of mass spectrometers can be used, and, in the absence of a consensual and standardized method, … |
HOPITAL FOCH | 2023-07-08 |
| 152 | Therapeutic Management and Current Situation Related to The Use of Resources and Costs of Spinal Muscular Atrophy (SMA) in Spain: A Retrospective, Multicenter Analysis Based on Medical Record Review. TREaSURE Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: An observational, retrospective, cross-sectional, multicenter study. Real-world data were obtained from medical records of Spanish public hospitals (9 hospitals). |
NOVARTIS | 2023-07-05 |
| 153 | Tick-borne Encephalitis Virus Research in Limousin PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Cases of encephalitis of varying severity have been described in recent years in eastern France involving tick-borne encephalitis virus (TBEV). The main objective is to demonstrate the presence of TBEV in Limousin, in patients with a positive Lyme serology, or a neurological picture compatible with TBEV. |
SEBASTIEN HANTZ; | 2023-07-01 |
| 154 | Clinical Evaluation of SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1). |
AUSDIAGNOSTICS PTY | 2023-07-01 |
| 155 | A Phase I/II Randomized Double Blind Controlled Study to Evaluate The Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The study is aim to evaluate the safety and immunogenicity of one dose TetraFluvac TF vaccine (15 μg HA per strain per dose) of the GPO seasonal quadrivalent inactivated split virion influenza vaccine in healthy adults aged 18 year and above over 90 days post-injection. |
PUNNEE PITISUTTITHUM; | 2023-07-01 |
| 156 | Emission Patterns of Respiratory Pathogens PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Airborne transmission represents one of the most rapidly spreading and dangerous dissemination mechanisms for pathogens. Public health strategies to prevent and control the often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment, if available, 2) isolation and barrier precautions such as face masks, and 3) decontamination of the exposed areas and surfaces. A lack of understanding how these pathogens are transmitted hampers the ability to develop effective prevention measures. This study will be used to collect preliminary data of the emission patterns of respiratory pathogens. |
WERNER BISCHOFF; | 2023-07-01 |
| 157 | Autonomous Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and Influenza Treatment System With Machine Learning in Outpatient Settings PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open-tabled, one-arm observatory trial to assess the effectiveness and safety of the Autonomous Treatment System Based on Machine Learning in patients with Covid-19, Post-Acute Sequelae of SARS-CoV-2 infection and influenza. |
LIZORA | 2023-06-16 |
| 158 | A Phase 2, Multi-Center, Randomized, Observer-Blind Study, to Evaluate Safety and Immunogenicity of Homologous or Heterologous Priming and Booster Vaccinations With H5N8 or H5N6 MF59-adjuvanted, Cell Culture-derived Influenza Vaccine in Healthy Subjects ≥18 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, … |
SEQIRUS | 2023-06-07 |
| 159 | A Phase 1, Randomized, Observer-Blind, Multi-Center, Dose Ranging Study to Evaluate The Immunogenicity, Safety and Tolerability of Different Formulations of An Adjuvanted or Non-Adjuvanted Cell Culture-derived A/H2N3 Subunit Influenza Virus Vaccine in Healthy Subjects 18 Years and Above PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, … |
SEQIRUS | 2023-06-01 |
| 160 | Active Surveillance of Influenza Virus Zoonotic Transmission Events: A Pilot Study in Belgium PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. People working with potentially infected animals have the highest risk. Moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, … |
CYRIL BARBEZANGE; | 2023-06-01 |
| 161 | Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in The Community PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The investigators propose a double-blind randomised placebo-controlled study in naturally occurring influenza virus infections in the community setting to compare the impact of a short course of clarithromycin versus placebo, on the clinical course, viral shedding, immunomodulation, and the antimicrobial resistance pattern of respiratory bacterial carriage of the patients. |
DENNIS KAI-MING IP; | 2023-06-01 |
| 162 | A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate The Efficacy and Safety of MK-4482 in Healthy Participants Inoculated With Experimental Influenza Virus PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a phase 2a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of molnupiravir (MK-4482) in healthy participants inoculated with experimental influenza virus. The primary hypotheses are that MK-4482 initiated 12 hours following intranasal inoculation of the influenza challenge virus reduces the peak viral load compared to placebo and that MK-4482 initiated 2 days following intranasal inoculation of the influenza challenge virus reduces the viral load area under the curve (AUC) compared to placebo. |
MERCK SHARP & DOHME | 2023-05-30 |
| 163 | UCLA Health Patient Health Maintenance With Interactive Text Reminder PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text message reminders impact patient engagement with primary care. This prospective randomized control trial is being implemented in conjunction with UCLA Health’s larger quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order to improve primary care preventive measure completion rates. |
RICHARD K. LEUCHTER; | 2023-05-23 |
| 164 | A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of A Universal Influenza (Uniflu) Vaccine With INFLUENZA G1 MHA in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (\>=) 18 to less than or equal to (\<=) 45 years of age. |
JANSSEN VACCINES & PREVENTION B V | 2023-05-17 |
| 165 | Investigation of The Passage of Antiviral Antibodies From Mother to Child PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Infections remain a major cause of neonatal morbidity and mortality worldwide. At birth, multiple microorganisms, to which they are particularly vulnerable given the immaturity and naïve nature of their immune system, … |
CHRISTELLE VAULOUP FELLOUS; | 2023-05-15 |
| 166 | Exhaled Breath Aerosol for The Etiological Diagnosis of Respiratory Tract Infections: A Pilot Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Pilot study for the evaluation of the feasibility of pathogen detection in exhaled breath aerosols (XBAs) samples using the AveloCollect device. The aim of the study is to evaluate the feasibility of XBA collection and molecular detection of respiratory pathogens using the AveloCollect BlowTube device (index test) in subjects with a clinical presentation consistent with a respiratory infectious disease, compared to the same molecular assays performed on nasopharyngeal secretions (using commercially available swabs) and sputum (comparator tests). |
DANIELA MARIA CIRILLO; | 2023-05-15 |
| 167 | Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate The Immunogenicity and The Safety of The Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly As 2 Separate Injections Into Opposite Arms, in Comparison to The Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given The Same Way in Healthy Subjects Aged 18 to 60 Years PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The present study OVX836-006 aims principally to: – Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms; – Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ; – Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response in two strata of subjects aged either 18-44 years or 45-60 years; – Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response; – … |
OSIVAX | 2023-05-10 |
| 168 | Randomized, Double-blind, Placebo-controlled Phase 1 Trial of The RSV/Flu-01E Vaccine for The Prevention of Respiratory Syncytial Virus Infection in Volunteers Aged 18 to 59 Years and Over 60 Years PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of the study is to investigate the safety and immunogenicity of the RSV/Flu-01E vaccine for the prevention of respiratory syncytial virus infection in volunteers aged18 to 59 years and over 60 years. |
TATYANA ZUBKOVA; | 2023-05-10 |
| 169 | Randomized, Double-blind, Placebo-controlled Phase 1 Trial of ТВ/Flu-05Е Intranasal Vector Vaccine for The Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of the study is to investigate safety, reactogenicity and immunogenicity of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years. |
TATYANA ZUBKOVA; | 2023-05-10 |
| 170 | A Single-blinded Sham-controlled Crossover Trial to Evaluate The Effect of Immunoadsorption on Post-Corona Virus Disease (COVID)-Syndrome PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to evaluate the efficiency and safety of immunoadsorption for the treatment of post-COVID syndrome (PCS). Efficacy will be measured (1) subjectively as an improvement of the score of questionnaires like the multidimensional fatigue inventory (MFI-20), Chalder fatigue scale, Bell-score, … |
JULIA WEINMANN-MENKE; | 2023-05-08 |
| 171 | The Technical and Operational Performance of The QuidelOrtho Savanna RVP4 Analyzer PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120 archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene (WSLH) by RT-PCR and multiplex respiratory pathogen panel within the last year. |
JONATHAN TEMTE; | 2023-05-05 |
| 172 | Investigating Uptake and Subsequent Health Outcomes Associated With Pfizer-BioNTech Bivalent COVID-19/Influenza Vaccine Concomitant Administration Using A Claims-based Real-world Data Source in The US Related Papers Related Patents Related Grants Related Experts View Highlight: This study intends to describe the characteristics of patients given the Pfizer-BioNTech bivalent mRNA COVID-19 vaccine and any commercially available influenza vaccines at the same time versus at different times. |
PFIZER | 2023-05-05 |
| 173 | A Stepped-Wedge Cluster Randomized Trial of Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary care visits are a key aspect of clinical care focused on helping patients to close care gaps related to preventive care such as vaccination, diabetes testing, statin therapy and cancer screening. However, less than 50% of care gaps are closed during these visits and new approaches are needed to prime patients for a discussion during these visits. In this study, the study team will evaluate a health system initiative that uses text messaging to patients in days preceding a primary care visit to prime patients to be amenable to ordering of vaccination, diabetes testing and cancer screening. |
ASCENSION SOUTH EAST MICHIGAN | 2023-05-01 |
| 174 | Promoting Protection of Others to Increase Future COVID-19 Booster Shot Vaccination Intentions in Younger Adult Canadians: Evaluating The Efficacy of Short Video-based Interventions PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: While COVID-19 vaccine uptake has generally been high in Canada, with 83.4% of the total population having received the first two doses (i.e., primary series), additional booster uptake has been slower, especially among young adults aged 18-39. Throughout the pandemic, young adults have experienced less personal risk from COVID-19 infection and this has led to lower motivation to vaccinate when it is recommended. Achieving high rates of up-to-date vaccine coverage is important in this group to anticipate new variants and waves of infection and changes to recommendations which might include annual or seasonal vaccination. Three video interventions, … |
ZEEV ROSBERGER; | 2023-05-01 |
| 175 | Clinical Validation of The LumiraDx SARS-CoV-2 & Flu A/B Test in Anterior Nares Nasal Samples For Point-of-Care (POC) Use PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 & Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation. |
RANDALL QUINN; | 2023-05-01 |
| 176 | A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate The Reactogenicity, Safety and Immunogenicity of MRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline’s (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA). |
GLAXOSMITHKLINE | 2023-04-27 |
| 177 | A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate The Immunogenicity, Reactogenicity and Safety of MRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against vaccine-matched influenza A and B strains at Day 29 and to evaluate the safety and reactogenicity of mRNA-1010. |
MODERNATX | 2023-04-17 |
| 178 | A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of One Monovalent Modified Influenza MRNA Vaccine Encapsulated in LNP, in Adults Aged 18 to 49 Years and 60 Years and Above PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1, parallel, randomized, active-controlled, multi-center, dose-esclation study with a Master Protocol design which will include several substudies that are developed to evaluate the safety and immunogenicity of different dose levels of modified messenger ribonucleic acid (mRNA) vaccines encoding full length hemagglutinin (HA) sequence of influenza virus encapsulated in lipid nanoparticles (LNPs) (hereafter referred to as HA mRNA vaccines) compared to control(s). The HA mRNA vaccine candidates and control(s) are presented in the substudy protocols. The aim is to generate clinical data across different substudies to provide learnings regarding the mRNA technology to support optimization of the mRNA platform including mRNA and LNP design and to support the decision of LNP and dose selection for future projects using mRNA technology. The purpose of this Substudy 01 is to evaluate the safety and immunogenicity of a single IM injection of up to 5 dose levels of a monovalent modified mRNA encoding the full-length HA sequence of A/Tasmania/503/2020 (H3N2) influenza virus encapsulated in LNP (hereafter referred to as H3 mRNA /LNP) administered as a single intramuscular (IM) injection in adults 18 to 49 years of age and 60 years of age and above, compared to the following active control: a quadrivalent recombinant influenza vaccine (RIV4). |
SANOFI PASTEUR A SANOFI COMPANY | 2023-04-17 |
| 179 | A Blind Randomized Clinical Trial, With Active Controls, to Evaluate The Immunogenicity and Safety of The Quadrivalent Influenza Vaccine (Split Virion, Inactivated) From Instituto Butantan, in Infants and Children Aged 6 to 35 Months PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age. |
BUTANTAN INSTITUTE | 2023-04-15 |
| 180 | Assessment Of Gene Expression Of Suppressor Of Cytokine 3, Interferons Alpha And Beta In Cutaneous Warts PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Warts are common epidermal growths caused by various strains of human papilloma virus (HPV). Viral warts are common with a prevalence rate of 7-12%. Human papilloma virus is small non enveloped viruses that contain a double-stranded DNA genome. There are more than 200 HPV genotypes are reported, however, the high-risk types, including HPV genotype-16 (HPV16), 18, 31, and 45, are the causes of 80% of cervical cancers. |
REHAM HELAL ABOELHAMD; | 2023-04-15 |
| 181 | A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. |
MODERNATX | 2023-04-14 |
| 182 | Systems Biological Assessment of The Durability of Vaccine Responses PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, … |
NADINE ROUPHAEL; | 2023-04-11 |
| 183 | A Phase 1, Open-Label, Comparator-Controlled, Dose-Escalation Study to Evaluate The Safety and Immunogenicity of A Single Dose of VRC H1ssF-3928 MRNA-LNP in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1, single-site, open-label, comparator-controlled dose escalating study of an intramuscularly (IM) administered mRNA-LNP vaccine encoding for (Vaccine Research Center) VRC H1ssF 3928 of up to 50 healthy adult volunteers aged 18 to 49 years, inclusive. This study is designed to assess the safety and immunogenicity of one dose of H1ssF 3928 mRNA Vaccine. Eligible participants will be sequentially enrolled into dosing groups (10 mcg, 25 mcg, and 50 mcg, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2023-04-05 |
| 184 | Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate The Efficacy, Immunogenicity and Safety of One Dose of OVX836 Influenza Vaccine 480μg, After Intramuscular Administration in Healthy Subjects Aged 18-55 Years PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The present study will evaluate the efficacy, immunogenicity and safety of one dose of OVX836 influenza vaccine 480μg, after intramuscular administration in healthy subjects aged 18-55 years. |
ODILE LAUNAY; | 2023-04-01 |
| 185 | Efficacy of Vitamin D Supplementation for Children With Bronchiolitis at Sohag University Hospital PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Vitamin D plays an important role in enhancing mucosal immune defense, decreasing excessive inflammation, and increasing mucociliary clearance. Experimental studies have shown that vitamin D reduces inflammation of epithelial cells in airways infected with Respiratory Syncytial Virus and confers antiviral effects. Furthermore, several studies have shown lower serum vitamin D levels in hospitalized children with bronchiolitis. However, studies on the efficacy of Vitamin D supplementation for children with bronchiolitis are scarce with inconsistent findings. In this study, we aim to evaluate the efficacy of vitamin D supplementation in children with bronchiolitis. |
YOUSTINA SAFWAT LABIB; | 2023-04-01 |
| 186 | A Phase 1/2, Randomized, Open-Label Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-1011.1, MRNA-1011.2, and MRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants. |
MODERNATX | 2023-03-27 |
| 187 | UCLA Health Patient Health Maintenance Text Reminder PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text message reminders impact patient engagement with primary care. This prospective randomized control trial is being implemented in conjunction with UCLA Health’s larger quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order to improve primary care preventive measure completion rates. |
RICHARD K. LEUCHTER; | 2023-03-23 |
| 188 | Characterization of Immunological Parameters in Blood from Healthy Participants Before and After High- to Moderate-intensity Aerobic Exercise PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Exercise has been shown to influence the immune system and, for example, improve anti-viral immune response. However, knowledge of how exercise impacts the immune system is still lacking. Therefore, … |
PER THOR STRATEN; | 2023-03-15 |
| 189 | UCLA Health Patient Health Maintenance Outreach Text Message PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text messages impact patient engagement with primary care. This prospective randomized control trial is being implemented in conjunction with UCLA Health’s larger quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order to improve primary care preventive measure completion rates. |
RICHARD K. LEUCHTER; | 2023-03-09 |
| 190 | A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY COMBINATION VACCINE CANDIDATES IN ADULTS 60 YEARS OF AGE AND OLDER PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The study aims to learn about the safety and effects of two new vaccines for RSV (RSVpreF) and influenza (modRNA qIRV) when given as a single shot compared to when given separately. RSV and influenza lead to infections, mainly in the fall and winter. These vaccines are being developed to help prevent respiratory syncytial virus (RSV) and influenza (Flu) disease. This study is seeking participants who: – are 60 years or older – are healthy or have well-controlled chronic conditions – have not had a flu shot in the last 120 days – … |
PFIZER | 2023-03-09 |
| 191 | Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, … |
TOBIAS TODSEN; | 2023-03-03 |
| 192 | MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test in home use. |
MEDICAL GROUP CARE | 2023-02-14 |
| 193 | A Prospective Multicenter Study Conducted to Evaluate The Performance of The LumiraDX SARS-CoV-2 Ag Ultra and LumiraDX SARS-CoV-2 & Flu A/B Tests At Point of Care Sites PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and LumiraDx SARS-CoV-2 \& Flu A/B test in differential detection of SARS-CoV-2, Influenza A (Flu A) and Influenza B (Flu B) at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and/or Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing in the device(s) under evaluation. |
LUMIRADX UK | 2023-02-09 |
| 194 | Immunogenicity and Safety of A Quadrivalent Influenza Virus Subunit Vaccine in Subjects Aged 6-35 Months : A Randomized, Double-blind, Active-controlled Phase III Trial PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months. A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, … |
AB&B BIOTECHNOLOGY CO LTD JS | 2023-02-06 |
| 195 | IVD_ Starfish_Clinical Performance Study Protocol for US – Project STARFISH – PRJ0002679 PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor. In order to meet the minimum sample requirements, and to demonstrate performance on a range of viral strains, the prospective collection may be supplemented with banked remnant nasal and/or nasopharyngeal samples. |
THERMO FISHER SCIENTIFIC | 2023-02-01 |
| 196 | Clinical Evaluation of The GRIP Influenza and SARS-CoV-2 Point-of-care Assays Using Fresh Patient Nasal Swab Samples PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this research is to determine if the use of a new device can accurately detect a virus infection. |
MATTHEW J. BINNICKER; | 2023-02-01 |
| 197 | A Novel Electrolyzed Water Spray Reduces The Number of Bacteria E-coli and An Attenuated Human Flu Virus on Human Hands PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to test whether spraying the hand of patients by use of the novel electrolyzed water spray will decrease the number of bacteria E-coli and the virus titer of an attenuated human flu virus. |
DOVE MEDICAL PRESS | 2023-01-29 |
| 198 | The Application and Research of Mesenchymal Stem Cells in Alleviating The Severe Development of Novel Coronavirus Infection to Clarify Its Safety and Effectiveness PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is to evaluate the safety and efficacy of umbilical cord mesenchymal stem cells Therapy for COVID-19. |
QUANHAI LI; | 2023-01-28 |
| 199 | ADaptive ASsessment of TReatments for InfluenzA: A Phase 2 Multi-centre Adaptive Randomised Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic Influenza Infection (AD ASTRA) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated influenza, to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential, adaptive, platform trial, we will compare the performance of available influenza antivirals, and those with potential activity, relative to the control (no treatment) and each other. AD ASTRA study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator |
UNIVERSITY OF OXFORD | 2023-01-22 |
| 200 | Uptake of The Childhood Live Attenuated Influenza Vaccine (LAIV) and Influenza-related Healthcare Resource Use in England During The 2012 to 2022 Flu Seasons; A Retrospective, Observational Study in The CPRD and HES Databases PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: In 2013, the NHS started a vaccination program in some regions of England to provide free flu vaccines to children aged 2 years or older, and younger than 16 years. The program has since been rolled out across England. Most children are given a vaccine that is sprayed into their nose. In clinical trials, this vaccine has been shown to protect children from experiencing severe flu symptoms. It is important to describe how it is used, … |
ASTRAZENECA | 2023-01-18 |
| 201 | Phase 1 Study of CodaLytic, An Intratumoral Influenza-based Oncolytic Virus, in Patients With Metastatic or Otherwise Inoperable Breast Cancer PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this phase 1 open label clinical trial is to evaluate the safety and preliminary efficacy of CodaLytic, an intratumorally-administered oncolytic virus, in patients with metastatic or otherwise inoperable breast cancer. The main questions it aims to answer are: – How safe is CodaLytic when administered in escalating dosing groups into targeted lesions? – … |
CODAGENIX | 2023-01-15 |
| 202 | A Randomized, Blind, Position-controlled Phase III Clinical Trial to Evaluate The Immunogenicity and Safety of Quadrivalent Influenza Virus Split Vaccine in 6-35 Months of Age PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety. |
TAO HUANG; | 2023-01-10 |
| 203 | Impact on The Use of Antibiotics of A Multimodal Algorithm for The Diagnosis and Management of Acute Community-acquired Pneumonia in The Emergency Room PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Reducing antibiotics prescription is still to date, the main goal in low respiratory tract infections (LRTI). Several studies have shown conflicting results on the impact of multiplex PCR as a point of care tool. Our experience has highlighted an impact on single room assignments during the winter season but not yet on antibiotics prescriptions. This project aims to evaluate a new multimodal algorithm including multiplex PCR at the point of care to reduce antibiotics prescription and therefore has the ability to have a positive impact on antibiotics resistance phenomenon. |
DONIA BOUZID; | 2023-01-09 |
| 204 | Effects of Probiotics in Immune Response to Influenza Vaccination in Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Assess efficacy of oral ingestion of a probiotic product on immune function in a population of healthy adult men and women in a clinical vaccination study. |
THE ARCHER DANIELS MIDLAND COMPANY | 2023-01-01 |
| 205 | A Phase 2, Randomized, Observer-Blinded Study to Evaluate The Safety and Immunogenicity of A SARS-CoV-2 RS Nanoparticle and Quadrivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Healthy Participants ≥ 50 to ≤ 80 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, observer-blinded, Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) (SARS-CoV-2 rS) nanoparticle and quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) combination vaccine with Matrix-M™ adjuvant; this combination vaccine. |
NOVAVAX | 2022-12-30 |
| 206 | ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients. They will also analyze whether these efforts lower the cost of care compared to standard of care. |
JULIA MOORE VOGEL; | 2022-12-22 |
| 207 | INFLUENCEF STUDY: Epidemiology, Risk Factors and Clinical Phenotype of Headache Associated With Influenza Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this observational analytic study with a cohort desing is to evaluate the epidemiology, risk factors and clinical phenotype of headache during Influenza infection. The study will be done in collaboration with the Healthcare Sentinel Network of Castile and Leon (Red Centinela Sanitaria de Castilla y León, RCSCYL) and the National Influenza Center of Valladolid (CNGV). First, the historical data of the VIGIRA network of the 2010-2022 flu seasons will be analyzed, assessing the epidemiology and risk factors of headache during Influenza infection; and second, … |
DAVID GARCÍA AZORÍN; | 2022-12-20 |
| 208 | Efficacy and Safety of Healsea® Hypertonic Nasal Spray 2.7% in The Treatment of Acute Infectious Rhinitis in Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Healsea® Rescue* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria. Healsea® Rescue* is indicated in adults for the treatment of symptoms of acute respiratory tract infections, rhinitis or rhinosinusitis, … |
EMIL KOLEV; | 2022-12-14 |
| 209 | Community-based Design and Evaluation of A Conversational Agent to Promote SARS-COV2 Vaccination in Black Churches PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of this study is to assess the use of and satisfaction with the ECA intervention over a 12-month period, its ability to increase SARS-CoV-2 and influenza vaccination in the BMATP community, and the comparative effectiveness of proactive engagement strategies and cultural tailoring on these factors. The Investigators will assess app use and satisfaction among these participants, along with self-reported vaccination attitudes and behavior, … |
NORTHEASTERN UNIVERSITY | 2022-12-12 |
| 210 | Safety and Immunogenicity of Quadrivalent Influenza MRNA Vaccine MRT5413 in Adults Aged 18 Years and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-dose (SD), QIV high-dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older. |
SANOFI PASTEUR A SANOFI COMPANY | 2022-12-12 |
| 211 | HBV Vaccination of Healthy Volunteers to Evaluate The Composition of Germinal Centers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Antibodies are the primary mediators of the protection against infection provided by vaccination. Antibodies become most powerful after the B cells that produce them undergo an evolutionary process called affinity maturation, in which antibodies increase their ability to bind to their targets, and thus neutralize pathogens. Affinity maturation occurs in structures within secondary lymphoid organs (for example lymph nodes or tonsils) known as germinal centers. Germinal centers are well known to be triggered by the first dose of vaccines, generating affinity matured plasma cells (B cells that secrete antibody into serum) and memory B cells, … |
GABRIEL D. VICTORA; | 2022-12-10 |
| 212 | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Study of The Safety and Efficacy of ADC189 Tablets in The Treatment of Influenza A Virus Infection/Influenza B Virus Infection in Adolescents and Adults PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection. The main aim to answer: – Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study. – … |
JIAXING ANDICON BIOTECH | 2022-12-07 |
| 213 | Prognostic Impact of Early Oseltamivir Carboxylate Low Plasma Concentration in Critically Ill Patients With Severe Influenza: A Prospective Cohort Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Introduction Pandemic and seasonal influenza epidemics can be associated with a high degree of morbidity and mortality, especially in patients developing severe influenza pneumonitis with the acute respiratory distress syndrome (ARDS) or the less frequent fulminant myocarditis. Early administration (i.e. in the first 48 hours) of the neuraminidase inhibitor oseltamivir is associated with reduced mortality in patients hospitalized for severe influenza. Early oseltamivir administration, which can only be given orally (or through a nasogastric tube), is thus recommended by the World Health Organization in patients hospitalized for severe influenza, including those requiring intensive care (ICU) admission. However, … |
ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS | 2022-12-01 |
| 214 | A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients. |
AVM BIOTECHNOLOGY | 2022-12-01 |
| 215 | Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection. The secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, … |
JENNIFER CAMERON; | 2022-11-30 |
| 216 | Safety and Immunogenicity of Quadrivalent Influenza MRNA Vaccine MRT5410 in Adults Aged 18 Years and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD \[adults ≥ 65 years of age only\], or RIV4) in adults 18 years of age and older. |
SANOFI PASTEUR A SANOFI COMPANY | 2022-11-28 |
| 217 | Clinical Efficacy of Xylitol Based Nasal Spray for The Treatment of Mild COVID-19 Infection PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. The nasal spray is comprised of xylitol and GSE (Grapefruit Seed extract) which provides antibacterial properties as well as preventing viral adhesion in the nasal passage. Studies into Xlear’s antiviral effects on SARS-CoV-2 are currently ongoing but hypothetically, a Xylitol Based Nasal spray may prove to be a useful and inexpensive treatment for COVID-19 infection. |
AHSAN W RATHORE; | 2022-11-28 |
| 218 | A Randomized, Double-blind Clinical Trial to Evaluate Lot-to-lot Consistency , Immunogenicity and Safety of Quadrivalent Influenza Vaccine (Split Virion), Inactivated in Health Populations Aged 9~59 Years Old PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated in health subjects aged 9-59 years old. |
QINGHU GUAN; | 2022-11-27 |
| 219 | Symphony IL-6 Study in Patients at Risk of Severe Sepsis Due to COVID-19 And/or Influenza Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, … |
BLUEJAY DIAGNOSTICS | 2022-11-22 |
| 220 | An Open Label, Single Arm Study to Evaluate Single and Multiple Dose Pharmacokinetics, Safety and Tolerability, and to Explore Clinical Outcomes of Treatment With Intravenous (IV) Zanamivir in Neonates and Infants Under 6 Months of Age With Confirmed Complicated Influenza Infection PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality. The PK, pharmacodynamics (PD), safety and efficacy of IV zanamivir have been evaluated in adults, adolescents and infants more than or equal to (\>=) 6 months of age with hospitalized influenza in the IV zanamivir global development program. However, antiviral treatment of neonates and infants under 6 months of age hospitalized with influenza infection remains a medical unmet need. Given the immaturity of the immune system at this age, … |
LEILA BIANCHI; | 2022-11-21 |
| 221 | Prevalence of Seasonal Influenza and Pneumococcal Vaccination and Determinants of Vaccination in The Elderly: Nested Case-Control Study PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The elderly population and individuals with chronic diseases are at high risk for influenza and influenza-related pneumonia, and it is emphasized that taking pneumonia and influenza vaccine together is effective in reducing mortality as well as hospitalization rates and costs due to pneumonia, influenza, … |
BELGIN AKIN; | 2022-11-15 |
| 222 | Comparison of 3% Normal Saline Nebulization Versus Steroid Nebulization in The Treatment of Bronchiolitis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To compare the efficacy of 3% normal saline nebulization and steroid nebulization in the treatment of bronchiolitis in infants. |
FAIZAN SADIQ; | 2022-11-15 |
| 223 | Evaluation of The Type 1 IFN Response in Viral Infections PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Respiratory viral infections (RVIs) represent a major public health problem and a great burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the source of an infection, microbiology laboratories routinely perform a crucial step: the search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety of pathogens, testing for the existence of all potential viruses, bacteria, or fungi accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic, … |
HOSPICES CIVILS DE LYON | 2022-11-11 |
| 224 | Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years. |
SANOFI PASTEUR A SANOFI COMPANY | 2022-11-10 |
| 225 | Modulation of Immune Responses to COVID-19 Vaccination By An Intervention on The Gut Microbiota: A Randomized Controlled Trial PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The elderly, who are often in poorer health, have been particularly affected by the COVID-19 pandemic. Recent study results show that while vaccines have been very effective in the short term, protection for the elderly may not be sufficient 6 months after the 2nd dose. Some countries have started to offer a 3rd dose. We are considering acting on the intestinal flora of the elderly (which is often unbalanced) in order to increase the effectiveness of the vaccination. Indeed, … |
UNIVERSITÉ DE SHERBROOKE | 2022-11-10 |
| 226 | Baby2Home (B2H) Mobile Health Application: A Randomized-Controlled Trial PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life. This randomized controlled trial will evaluate whether, compared to usual care, Baby2Home 1) improves maternal, paternal, and infant health service utilization outcomes over the first year postpartum, … |
EMILY MILLER; | 2022-11-09 |
| 227 | Impact of The Presence of Anti-interferon Autoantibodies on The Viral Load in Severe Respiratory Infections in Intensive Care PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Type I interferons (IFN-I) production is induced by the detection of viral molecules, such as RNA or DNA viral strands, through pattern recognition receptors (PRR) present on many immune cell types. Despite a minimal concentration, IFN-I secretion activate the secretion, by neighbouring cells, of more than 700 proteins with antiviral properties (inhibition of viral replication, destabilization of virus membranes, etc.). IFN-I constitute therefore one of the major first line of defence established by the immune system in response to viral infection. Briefly, during the Coronavirus disease (COVID-19) pandemic, several teams including ours, … |
FLORENT WALLET; | 2022-11-08 |
| 228 | Post-market, Randomized and Controlled Clinical Study to Assess The Performance and Safety of Sentinox in The Prevention of Acute Respiratory Infections PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a post market, single-center, randomized, controlled, clinical study to assessTo evaluate the performance of self-administered Sentinox intranasal spray in preventing ARI caused by at least one respiratory virus |
APR APPLIED PHARMA RESEARCH S A | 2022-11-07 |
| 229 | Randomized Controlled Trial, Double Blind, Phase III, to Evaluate The Immunogenicity of An Adjuvanted Influenza Vaccine Among Health Care Personnel (EDUCATE) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This randomized, double-blinded trial will assess humoral immune responses to adjuvanted, egg-based quadrivalent influenza vaccines compared to unadjuvanted, standard dose, egg-based quadrivalent influenza vaccines among healthcare personnel (HCP). The trial will be conducted at two sites in Lima, Peru during 2022 and 2023. |
GISELLE SOTO; | 2022-11-04 |
| 230 | Multicenter, Randomized, Open, Phase III, Trial Assessing The Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Obesity has been considered as a risk factor for mortality and development of complications during infection with the influenza virus. Several case studies of severe and fatal infections have identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, … |
ODILE LAUNAY; | 2022-11-04 |
| 231 | A Parallel-group, Phase I/II, Randomized, Modified Double-blind, 3-arm, Active Comparator, Multi-center, Prevention Study to Evaluate The Immunogenicity and Safety of Two Adjuvanted Dose Levels of Panblok H7+MF59 Influenza Vaccine Compared With An Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, … |
SANOFI PASTEUR A SANOFI COMPANY | 2022-11-03 |
| 232 | Emergency PanorOmic Wide Association Study in Respiratory Infectious Disease (ePWAS-RID) PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Develop an emergency PanorOmics Wide Association Study (ePWAS) for the early, rapid biological and pathophysiological characterisation of known and novel Infectious Diseases in adult patients presenting to emergency departments with suspected, acute, community-acquired respiratory infectious disease (scaRID). Phase 1 1. Develop an ED-ID biobank (named ePWAS-RID). Phase 2 2. Targeted research for the discovery of novel diagnostics, prognostics and therapeutics |
TIMOTHY HUDSON RAINER; | 2022-11-02 |
| 233 | Phase 2, Open-Label Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29. |
MODERNATX | 2022-11-02 |
| 234 | Using The CRP Test in Children Under 12 Years With Respiratory Symptoms in Kyrgyz Republic PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Rationale: Overuse of antibiotics globally is leading to increasing rates of antibiotic resistance and may lead to a ‘post-antibiotic’ era. Case fatality rates for pneumonia in children remain high in Central Asia and there is a lack of knowledge of which viruses and bacteria cause the disease. Antibiotic resistance patterns of common bacteria remain largely unknown in Central Asia which makes it challenging for clinicians to choose the right antibiotic to treat children with suspected bacterial pneumonia and sometimes healthcare workers overuse an antibacterial therapy even when the child does not need it. Randomised trials of using CRP point of care test (POCT) to guide antibiotic prescription for respiratory tract infections has been successful in lowering unnecessary antibiotic prescriptions in adults in high income countries but left a small concern for safety in the form of possibly slightly increased risk of hospitalisation in the CRP group. Objective: This study seeks to gain evidence on whether use of C-reactive protein point-of-care test can safely decrease prescription of antibiotics for children under 12 with acute respiratory symptoms in primary level healthcare centres in Kyrgyzstan. Study design: Multicentre, open-label, individual randomised controlled clinical trial with 14 days blinded follow-up in rural Chui and Naryn regions of Kyrgyz Republic. Healthcare workers from ten selected healthcare centres will be trained in the CRP POCT and in interpreting the results in the field. Study population: Children aged from 6 month to 12 years attending the primary level healthcare centres during normal business hours with acute respiratory symptoms. Main study parameters: The proportion of patients in the two groups prescribed an antibiotic within 14 days of index consultation; length of disease, antibiotics given at index consultation, admissions and vital status. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks, inconvenience and burden associated with participating in this observational study are low. As part of the inclusion children in the CRP cluster group will have a finger-prick test performed. This may be unpleasant and course transient discomfort but poses no risks to the child. Follow-up will be three short phone calls day 3, 7 and 14 after inclusion. Risks includes possible undertreatment of serious disease, however previous studies have not found safety issues with CRP testing in children. There is no direct benefit to participants, but side effects and non-necessary medications are likely minimised. |
JESPER KJÆRGAARD; | 2022-11-01 |
| 235 | Interventional Pilot Study to Evaluate The Effect of A Resveratrol-based Nasal Spray Associated With Carboxymethylbetaglucan in Isotonic Solution in The Prevention of RTI in Children With Pre-school Wheezing PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To determine whether or not preventive administration of resveratrol in the form of a nasal spray is effective in reducing the number of asthma exacerbations typical of preschool wheezing children who develop viral infections. |
MICHELE MIRAGLIA DEL GIUDICE; | 2022-11-01 |
| 236 | AIDI – Research and Development of A Multisensor-Based Technology for Real-time Automated Detection of Post-acute COVID-19 Sequelae PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: We are conducting a research study at the VA hospital in Bedford, MA to learn more about how a multisensor rapid health assessment device, MouthLab, can help predict or anticipate future health complications in patients with underline conditions after contracting COVID-19. The device was created by a health technology and digital medicine company called Aidar Health, Inc. MouthLab is a non-invasive, hand-held device that works like a breathalyzer. An individual breathes into the device for 60 seconds and the MouthLab gathers more than 10 vital health parameters like temperature, heart rate, SpO2, ECG, … |
VARSHA VIMALANANDA; | 2022-10-31 |
| 237 | A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Evaluate The Efficacy and Safety of VIR-2482 for The Prevention of Illness Due to Influenza A PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIR-2482 compared to placebo in preventing influenza A illness in healthy adults 18 to <65 years of age without pre-existing risk factors for serious complications from influenza infection. |
VIR BIOTECHNOLOGY | 2022-10-30 |
| 238 | A PHASE 1 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either: – qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations – qIRV (22/23) at dose level 1, – qIRV (22/23) at dose level 2, or – bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV). |
BIONTECH SE | 2022-10-28 |
| 239 | International Sites: CONNECTS Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue) PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. |
ANTON POZNIAK; | 2022-10-27 |
| 240 | Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children (EPIC Study) PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Pregnant women and children with chronic medical conditions are at increased risk of hospitalisation, intensive care admission and death from influenza and COVID-19 infections. However, there appears to be a high level of vaccine hesitancy among women of reproductive age. We will develop nudge interventions to improve influenza and COVID vaccine uptake among pregnant women and medically at risk children and test the effectiveness of the interventions using randomised controlled trials. |
HELEN MARSHALL; | 2022-10-26 |
| 241 | Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants. |
SANOFI PASTEUR A SANOFI COMPANY | 2022-10-25 |
| 242 | Melatonin and Vaccine Response, Immunity, and Chronobiology Study (MAVRICS): The Impact of Sleep, Circadian Health, and Melatonin on Vaccine Immunogenicity and Outcomes PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity. |
RACHEL LEE; | 2022-10-25 |
| 243 | A Multicenter Prospective Cohort Study of The Clinical Characteristics and Prognosis of Respiratory Failure Patients With ECMO Therapy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The present study is a multicentre cohort study. Respiratory failure patients treated with extracorporeal membrane oxygenation (ECMO) were enrolled. Clinical data before and during ECMO treatment were collected. Clinical data before and during ECMO treatment were collected. By this retrospective clinical data and prospective study, to observe the current status of respiratory failure patients treated with ECMO in China, analyze the clinical characteristics and prognosis of patients, and explore the clinical prevention and treatment strategies of major complications of ECMO. |
QINGYUAN ZHAN; | 2022-10-20 |
| 244 | Low-grade Inflammatory Challenge and Social Behavior PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This randomized, double-blind, placebo-controlled study of the influenza vaccine will shed important light on how the immune system responds to different positive and negative social experiences. Building on the nuanced animal literature showing that, while animals exposed to an inflammatory challenge show reductions in social exploration consistent with the sickness behavior of social withdrawal, they actually show increases in social engagement behavior during interactions with a cage mate or pair-bonded animal. The present study will examine if a mild inflammatory challenge (receipt of the influenza vaccine) leads to change in actual social behavior in interactions, … |
KEELY MUSCATELL; | 2022-10-17 |
| 245 | A Phase I Clinical Trial to Evaluate The Safety and Tolerability of VLP Peanut in Healthy Subjects and Subjects With Peanut Allergy and to Explore Preliminary Signals of Its Efficacy (PROTECT) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA. |
ALLERGY THERAPEUTICS | 2022-10-17 |
| 246 | A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate The Immune Response, Safety and Reactogenicity of An RSVPreF3 OA Investigational Vaccine When Co-administered With FLU AQIV (Inactivated Influenza Vaccine – Adjuvanted) in Adults Aged 65 Years and Above PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA). |
GLAXOSMITHKLINE | 2022-10-14 |
| 247 | Phase 1, Randomized, Observer-blind Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines MRNA-1045 (Influenza and RSV) or MRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With MRNA-1010 (Influenza), MRNA-1345 (RSV), and MRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years of Age PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants. |
MODERNATX | 2022-10-14 |
| 248 | Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines Among Healthcare Workers : A Single Center Prospective Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthcare workers (HCWs) during 2022-23 season. |
MIN JOO CHOI; | 2022-10-12 |
| 249 | Immune Benefits of Blueberry Consumption and Response to Influenza Vaccination in Overweight Older Men and Postmenopausal Women: A Randomized Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight older men and postmenopausal women |
JOAN SABATE; | 2022-10-12 |
| 250 | Performance Evaluation of The Lucira COVID-19 & Flu Test Versus FDA Authorized SARS-CoV-2 and Influenza A&B Assays PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The Lucira COVID-19& Flu Test is a real-time RT-LAMP test intended for the qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A and Influenza B in self-collected nasal swab samples. The test consists of a nasal swab, a sample vial the nasal swab sample is placed in to prepare the sample for testing, and a test unit which detects whether SARS-CoV-2, Influenza A, and Influenza B virus is present within the specimen. The Lucira test uses a proprietary, molecular based detection process to detect whether a person is actively shedding the genomic RNA from the SARS-CoV-2, Influenza A, … |
LUCIRA HEALTH | 2022-10-11 |
| 251 | Evaluating The Effect of Different Daily Plant Stanol Ester Intakes on The Vaccination Response to An Influenza Vaccine PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C). However, recent studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. BMI and age have previously been negatively associated to vaccination responses. If plant stanols indeed have beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming plant stanols prior to receiving the influenza vaccination. |
MAASTRICHT UNIVERSITY MEDICAL CENTER | 2022-10-11 |
| 252 | Response to Influenza Vaccination in Pediatric Oncology Patients PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine. Primary Objective * To determine the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. * To describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, … |
RAMILO OCTAVIO; | 2022-10-07 |
| 253 | Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High-dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During The Influenza Season 2022/23 PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) of suspected adverse drug reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2022/23. The secondary objectives of the study are: – To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, … |
SANOFI PASTEUR A SANOFI COMPANY | 2022-10-06 |
| 254 | Safety and Immunogenicity of Quadrivalent Influenza MRNA Vaccine MRT5407 in Adults Aged 18 Years and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 2 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5407 compared to an active control (QIV standard-dose (SD), QIV high-dose (HD) [adults ≥ 65 years of age only], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older. |
SANOFI PASTEUR A SANOFI COMPANY | 2022-10-03 |
| 255 | A Randomized First-in-human, Observer-blind, 3-arm Study to Evaluate Safety, Tolerability, and Immunogenicity of A Single Administration of TETRALITE, A Novel Adjuvanted, Low-dose Influenza Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: There is an obvious need for an affordable and more effective seasonal influenza vaccine. TETRALITE is a novel, inactivated, adjuvanted influenza vaccine combining a low dose of a licensed vaccine with the novel, potent LiteVax Adjuvant. A licensed vaccine (Cohort 1) with a normal dose [15 ug per strain] and no adjuvant will be compared with two TETRALITE study vaccines with 1/5th of the licensed vaccine added with a low (Cohort 2) or high (Cohort 3) dose of LiteVax Adjuvant. |
ISABEL LEROUX-ROELS; | 2022-10-03 |
| 256 | Nasal Mucosal Immune Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Phenotypes PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will determine the functional status of the nasal immune environment with LAIV exposure in COPD persons with frequent exacerbations (defined as individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months) and COPD persons without frequent exacerbations to determine acute exacerbation of COPD (AECOPD)-associated dysfunction in a) cytokines and immune effector cells of the nasal mucosa and b) viral replication. The investigators hypothesize that: 1) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate altered mucosal immune responses to LAIV exposure, … |
MICHAEL B DRUMMOND; | 2022-10-03 |
| 257 | PROmotion of FLU Vaccine Uptake in The Emergency Department – PROFLUVAXED PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this research is to increase influenza vaccine acceptance and uptake in vulnerable populations whose primary (and often only) health care access occurs in emergency departments (ED Usual Source of Care Patients). Toward this goal, the investigators will conduct one on one interviews and focus groups with ED Usual Source of Care Patients and community partners and produce trusted messaging informational platforms (PROmotion of FLU VA(X)ccination in the Emergency Department – PROFLUVAXED) that will address barriers to flu vaccination, especially vaccine hesitancy. The investigators will then conduct a cluster-randomized, … |
ROBERT RODRIGUEZ; | 2022-10-01 |
| 258 | Prospective In Vitro Diagnostic Clinical Performance Study for An Influenza A+B Point-of-Care Test Kit on Patients Exhibiting Influenza-like Illness PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Prospective clinical study on the performance of an Influenza A+B rapid test kit. The main goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to a gold standard. Option of participating in this clinical study will be presented to patients displaying influenza-like illness. Informed consent will be collected from patients or patient’s next of kin/guardian before samples (nasopharyngeal swab) are taken from the patient. Nasopharyngeal swabs are tested using both the investigational test kit and a predicate fluorescence immunoassay test kit. All samples will be tested using a molecular-based PCR test kit as a confirmatory test. The results will be analysed statistically and the performance of the Influenza A+B test kit can be evaluated. |
PAUL KS CHAN; | 2022-10-01 |
| 259 | Systems Biology Analysis of Vaccine-induced Immunity to Infectious Diseases in Healthy Participants and Participants With Cancer PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Many cancer patients are highly susceptible to infection and respond poorly to vaccination. This observational study will determine molecular and cellular features of immunity to viral pathogens in participants with cancer and compare them to healthy controls. The aim is to identify how antiviral immunity in participants with cancer differs from that in healthy participants to understand why cancer patients are more susceptible to infections. In this context, … |
UNIVERSITY HOSPITAL TUEBINGEN | 2022-10-01 |
| 260 | A Randomized, Double Blind, Placebo Controlled Trial of Intravenous N-acetylcysteine and Oseltamivir Versus Intravenous 5% Dextrose and Oseltamivir in Adults Hospitalized With Influenza Complicated By Lower Respiratory Tract Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Seasonal influenza epidemics are important causes of morbidity and mortality. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza. Early therapy with a neuraminidase inhibitor (NAI) is associated with better outcome in patients hospitalized with influenza, but significant mortality occurs despite use of antivirals. N-acetylcysteine (NAC) is a modified form of the amino acid cysteine, with anti-oxidant properties. NAC was shown to inhibit the production of pro-inflammatory molecules in lung epithelial cells infected with influenza viruses. Previous case report showed that high dose NAC, administered as continuous intravenous infusion, … |
DAVID SHU CHEONG HUI; | 2022-10-01 |
| 261 | A Randomized Controlled Trial of Adjunctive Sirolimus and Oseltamivir Versus Oseltamivir Alone for Treatment of Influenza PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Seasonal influenza epidemics are important causes of mortality and morbidity. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza A(H1N1)pdm09 virus infection, A(H5N1) infection, and A(H7N9) infection. We aim to investigate the effects of adjunctive sirolimus in adults hospitalized with influenza A or B infections involving the lower respiratory tract. |
DAVID SHU CHEONG HUI; | 2022-10-01 |
| 262 | Acceptability, Cost-Effectiveness, and Capacity of A Facility-Based Seasonal Influenza Vaccination: A Study in Selected Hospitals of Bangladesh PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: In Bangladesh, seasonal influenza imposes considerable health and economic burden, particularly for those at high risk of severe disease. To prevent influenza and lessen the economic burden, despite the World Health Organization’s (WHO) recommendation of seasonal influenza vaccination prioritizing high-risk groups, many low-income countries, including Bangladesh, lack a national policy/programme and relevant statistics on seasonal influenza vaccination. Objectives: 1. To determine influenza vaccine acceptability, health beliefs, barriers, … |
INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH BANGLADESH | 2022-09-29 |
| 263 | Investigation and Comparison of The Antibody Response Initiated By Recombinant, Cell-Based and Egg-Based Influenza Vaccines PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a prospective randomised trial of 3 influenza vaccine formulations with different manufacturing processes: 1) egg-grown (QIV-E); 2) cell-grown (QIV-C); and 3) recombinant protein (QIV-R). The main objective is to compare the antibody responses following influenza vaccination among these 3 vaccines to determine whether recombinant vaccines offer superior protection over standard egg or cell-based formulations. The attenuating effects of prior vaccination on vaccine immunogenicity will also be evaluated. Hypothesis: Vaccination with recombinant vaccine results in better antibody responses, particularly against A(H3N2) viruses, than either standard egg-grown vaccines or cell-grown vaccines. |
BARNABY YOUNG; | 2022-09-29 |
| 264 | CSP #2038 – COVID-19 Pharmacotherapy Effectiveness in The VA Healthcare System (COPE-VA) PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to comprehensively describe the temporal and geographic utilization of COVID-19 therapies used for mild to moderate disease during different periods of SARS-CoV-2 variant circulation as well as to compare demographic and clinical characteristics of Veterans who are treated or do not receive these different therapies. The investigators will also perform similar descriptive epidemiology for other respiratory viruses, including RSV and influenza and other infectious diseases. This first phase will critically inform feasibility and direction of the second phase, … |
VA OFFICE OF RESEARCH AND DEVELOPMENT | 2022-09-26 |
| 265 | Enhancing Innate Anti-Viral Resistance Through A Community-Based Intervention – Generation Xchange PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This randomized controlled trial will test whether a recently developed community-based intergenerational mentoring program known as Generation Xchange (GenX) can enhance antiviral resistance in older African-American women and men in a low-SES urban community. Additional studies will identify the biological processes that promote resistance to respiratory virus infections and viral disease in older African-American women and men. |
STEVE COLE; | 2022-09-26 |
| 266 | A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate The Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination. |
MERCK SHARP & DOHME | 2022-09-23 |
| 267 | A Pragmatic Randomized Trial to Evaluate The Effectiveness of High-Dose Quadrivalent Influenza Vaccine Vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this pragmatic randomized trial is to evaluate the relative vaccine effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) in older adults. Participants will be randomized 1:1 to either QIV-HD or QIV-SD. |
TOR BIERING-SØRENSEN; | 2022-09-22 |
| 268 | Multicenter, Double-blind, Randomized, Parallel Group Study to Evaluate The Immunogenicity, Reactogenicity and Safety of The Grippol® Quadrivalent Vaccine in Children Aged 6 Months to 5 Years (Inclusive) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination. |
NPO PETROVAX | 2022-09-21 |
| 269 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Evaluate The Efficacy and Safety of ZX-7101A Tablets in Adults With Uncomplicated Influenza PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are: – The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza. – The safety of ZX-7101A in Chinese Adults patients with uncomplicated influenza. |
HONG WEN ZHANG; | 2022-09-17 |
| 270 | Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. This study will investigate investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among eligible influenza vaccination candidates. |
TOR BIERING-SØRENSEN; | 2022-09-16 |
| 271 | Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: this study will be conducted to investigate the effect of Active Cycle Breathing Technique and incentive spirometer on COVID19 patient |
CAIRO UNIVERSITY | 2022-09-15 |
| 272 | A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate The Safety and Efficacy of MRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older. |
MODERNATX | 2022-09-14 |
| 273 | Improving Influenza Vaccination Delivery Across A Health System By The Electronic Health Records Patient Portal RCT 5 (LADHS) PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial is taking place in Los Angeles, CA at clinics within the Los Angeles Department of Health clinics. The study design is a comparative effectiveness trial design. Patients will be randomized into 1) receiving enhanced texting with a callback by a trained call-center staff member to schedule a vaccine visit if the patient presses 1 in response to the text, 2) receiving enhanced bidirectional texting with a texting response from a trained call-center staff member who will help the patient schedule a vaccine visit through a series of back-and-forth texts, … |
PETER G SZILAGYI; | 2022-09-13 |
| 274 | Nudging Flu Vaccination in Patients at Moderately High Risk for Flu and Flu-related Complications PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will test the relative efficacy of high-risk messages in increasing flu shot rates in patients at moderately high risk for flu and complications (those in the top 11-20% of risk). It will also examine whether informing patients that their high-risk status was determined by analyzing their medical records or by an artificial intelligence (AI) / machine-learning (ML) algorithm analyzing their medical records will affect the likelihood of receiving a flu vaccine. |
CHRISTOPHER F CHABRIS; | 2022-09-13 |
| 275 | Randomized Participant- and Investigator-Blinded Trial to Compare The Clinical Efficacy of Recombinant Influenza Vaccine to Standard Dose Egg-Based Inactivated Influenza Vaccine Among Adults Aged 18-64 Years in The United States PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This randomized, active comparator trial will compare the clinical efficacy of recombinant influenza vaccine (RIV) to standard-dose egg-based inactivated influenza vaccine (SD IIV) among adults aged 18-64 years. The primary study hypothesis is that the clinical efficacy of RIV is superior to that of SD IIV to prevent and attenuate influenza-like illness (ILI)-associated influenza virus infection. Relative efficacy will be assessed by comparing rates of ILI-associated reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza virus infection and measures of infection and illness attenuation among participants who receive RIV versus SD IIV. A secondary hypothesis is that humoral and cell-mediated immune responses to RIV are superior to responses to SD IIV. Relative immunogenicity will be assessed by comparing markers of humoral and cell-mediated immune responses post-vaccination among a subset of participants who receive RIV versus SD IIV. |
FATIMAH DAWOOD; | 2022-09-13 |
| 276 | A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA COMPARED TO LICENSED INACTIVATED INFLUENZA VACCINE IN HEALTHY ADULTS 18 YEARS OF AGE OR OLDER PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older. |
PFIZER | 2022-09-12 |
| 277 | Survivorship Plan HEalth REcord (SPHERE) Implementation Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To understand the effectiveness and implementation of the SCP-PHR, we will conduct a hybrid type 1 effectiveness-implementation trial consisting of the following components: (A) a randomized clinical effectiveness trial, and (B) a mixed methods implementation study. |
DAVID A. HAGGSTROM; | 2022-09-09 |
| 278 | A Proof-of-concept, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Assess The Prophylactic Antiviral Activity Against Influenza, Safety, Tolerability, and Pharmacokinetics of CD388 Via A Human Viral Challenge Model PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the preventative antiviral activity of CD388, as compared to saline placebo, when administered as a single dose to healthy adult participants in a human viral challenge model of influenza. |
ARUN ANANDAKUMAR; | 2022-09-09 |
| 279 | Improving Influenza Vaccination Delivery Across A Health System By The Electronic Health Records Patient Portal RCT 5 PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial is taking place in Los Angeles, CA at clinics within the UCLA Health System. The study design is a 2×2 nested factorial design. Patients will be randomized into 1) receiving text based reminder messages with direct scheduling link, 2) portal-based reminder messages with direct scheduling link, or 3) the control group. Patients randomized to the intervention arms will receive reminders if they are due for influenza vaccine. Nested within the portal reminder arm, we will have two additional components for which patients will be randomized separately: 1. A pre-commitment prompt, asking patients which time (September, October, … |
PETER G SZILAGYI; | 2022-09-07 |
| 280 | An Exploratory Study to Establish The Dose, Safety and Pathogenicity of A New Influenza H1N1 Challenge Strain in Healthy Participants 18 to 55 Years of Age PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A total of up to 90 participants may be given H1N1 influenza challenge virus. In Part A, 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2). Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose 2, or another virus dose (e.g., Virus Dose 3) |
HVIVO | 2022-09-07 |
| 281 | Alerts With Risk Information to Increase Influenza Vaccinations PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess, prospectively, the effect on flu vaccination rates of salient alerts in the electronic health record that indicate a patient’s high risk for flu and its complications. The investigators hypothesize that the salient alerts will lead to increased flu vaccination compared with a standard flu alert. |
CHRISTOPHER F CHABRIS; | 2022-09-01 |
| 282 | Digital Health Intervention On Awareness Of Vaccination Against Influenza Among Adults With Diabetes PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The study leveraged the Dario digital health platform to retrospectively analyze data from 64,904 users with diabetes assigned by the platform into three groups: Group A received previously studied monthly flu nudge messages; Group B received an adapted intervention with 2-3 monthly messages; Group C served as the control with no intervention. Surveys were conducted at baseline, three months, and six months to assess vaccination status, awareness of influenza risks, and recollection of educational content. Statistical analyses, including logistic regression, Chi-square tests, and t-tests, were used to evaluate differences between groups. |
LABSTYLE INNOVATIONS | 2022-09-01 |
| 283 | Phase Ⅲ, Randomized, Double-blind, Active Controlled to Evaluate The Immunogenicity and Safety of IL-YANG Quadrivalent Seasonal Influenza Vaccine in Healthy Infants From 6 Months to Under 3 Years of Age(≥ 6 Months and < 3 Years) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and < 3 years) |
IL YANG PHARM | 2022-09-01 |
| 284 | Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-2) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Observational study about adherence to guidelines for Covid-19, Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus. |
CASTILLA LA MANCHA HEALTH SERVICE | 2022-09-01 |
| 285 | Snack Foods and Their Impact on Immune Optimisation to The Influenza Vaccination: A Randomised Controlled Trial of A Vaccination Model of Immune Response PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the impact of replacing usual snacks with alternative snack foods on the immune response to influenza vaccination in a population of healthy, middle-aged adults. |
KING’S COLLEGE LONDON | 2022-09-01 |
| 286 | Attitudes and Believes About Vaccinations in A Supportive Care Patient Population PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To learn about the attitudes and beliefs towards vaccination both before and after the COVID-19 pandemic in patients who have received supportive care. |
MICHAEL TANG; | 2022-08-31 |
| 287 | A Phase 2b, Randomized, Observer-Blind, Antigen and Adjuvant Dose-Confirmation Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 2, randomized, observer-blind, dose-confirmation Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects are to be randomized into 1 of 4 possible treatment groups with 250 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data. |
SEQIRUS | 2022-08-25 |
| 288 | Comorbidities And Complications Associated With Covid-19 Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the spectrum of comorbidities and complications and its impact on the clinical outcome in hospitalized patients with coronavirus disease 2019 (COVID-19). |
MAHMOUD GAMAL HUSSEIN; | 2022-08-25 |
| 289 | Impact of High Dietary Fiber on Microbiome and Vaccine Responses PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To learn if diet can enhance the microbes (such as bacteria and viruses) found in your gut and improve the body’s immune response to the influenza (flu) vaccine. |
JENNIFER WARGO; | 2022-08-23 |
| 290 | Pre-visit Questionnaire to Increase Influenza Vaccinations PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess, prospectively, the effect on flu vaccination rates of a pre-visit questionnaire that asks patients to indicate their preferences for a flu shot. Responses to the questionnaire will also be shown to clinicians via additional text in an existing flu shot alert. The investigators hypothesize that the pre-visit questionnaire will lead to increased flu vaccination compared with standard practices. |
CHRISTOPHER F CHABRIS; | 2022-08-18 |
| 291 | A Randomized, Double-blind, Placebo-controlled, Phase 2a Study To Assess The Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza, Via A Human Viral Challenge Model in Healthy Adult Participants PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants |
MELISSA BEVAN; | 2022-08-12 |
| 292 | A Phase 1 Randomized, Observer-blind, Dose-escalation Study to Evaluate The Safety, Reactogenicity and Immunogenicity of An MRNA-based Monovalent Influenza Vaccine Candidate in Healthy Younger and Older Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline’s (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA). |
GLAXOSMITHKLINE | 2022-08-09 |
| 293 | Nasal Immune Challenge Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Respiratory viral infections cause significant illness, especially in vulnerable individuals and is a topic of immense significance during the current COVID-19 global pandemic. Respiratory diseases such as asthma involve inflammation of the airways and viruses are a major cause of asthma attacks. The nose is easier to access than the lungs but has similar cells and is therefore useful to study immune responses throughout the respiratory tract. Rather than study the effects of a live virus on the immune system, … |
AKHILESH JHA; | 2022-08-09 |
| 294 | An Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate The Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35months PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The study of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co., Ltd will conduct in two phases,the phaseⅠclinical trial of the study will be open-label design,and the phase III clinical trial of the study will be randomized, double-blind, active controlled design.the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged 6 to 35 months. |
HONGXING PAN; | 2022-08-08 |
| 295 | Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Pediatric cancer survivors have increased infection-related morbidity and mortality. This study will evaluate immune dysfunction following cancer directed systemic therapy completion, with attention to clinical relevance and infection rate in this population compared to healthy siblings, when applicable. The investigators will also restart vaccinations at earlier time points than previously studied, at 3 months post therapy, and will assess whether boosters or revaccination schedules are superior for regaining immunity against potentially serious infections in survivors. |
ASHLEY HINSON; | 2022-08-08 |
| 296 | Immunogenicity and Safety of Inactivated COVID-19 Vaccine Coadministered With 23-valent Pneumococcal Polysaccharide Vaccine and Quadrivalent Influenza Vaccine in Hemodialysis Population: A Multicentre, Randomised, Controlled, Phase 4 Trial PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population. |
TAO HUANG; | 2022-08-05 |
| 297 | A Double-blind, Randomized, Placebo-controlled, Comparative, Multicenter Phase III Clinical Trial to Study The Clinical Efficacy and Safety of XC221, Tablets, 100 Mg in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of the study was to evaluate the effectiveness of XC221, tablets, at a dose of 200 mg/day compared to placebo in patients with uncomplicated influenza or other acute respiratory viral infections (ARIs). An additional purpose of the study was to evaluate the safety of XC221, tablets, at a dose of 200 mg/day compared to placebo in patients with uncomplicated influenza or other ARIs. |
VALENTA PHARM JSC | 2022-08-05 |
| 298 | Characterisation of The Effects of Spermidine, A Nutrition Supplement, on The Immune Memory Response to Coronavirus Vaccine in Older People PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Easing the morbidity and economic burden of age-related diseases is one of the major medical challenges. One of the key obstacles to healthy ageing is immune senescence, including the failure of lymphocytes to respond adequately to infection, malignancy and vaccination. Infectious diseases remain the fourth most common cause of death among the elderly in the developed world. Moreover, the gain of chronic low-grade non-specific inflammation with age contributes to many age-related diseases. Our early work showed that autophagy, the main cellular bulk degradation pathway in the cell, … |
KATJA SIMON; | 2022-08-01 |
| 299 | A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on The Safety and Efficacy of GP681 Tablets in The Treatment of Acute Uncomplicated Influenza PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 to 65 years with acute uncomplicated influenza virus infection |
BIN CAO; | 2022-07-28 |
| 300 | A Phase 2, Randomized, Study to Evaluate Safety and Immunogenicity of One or Two Heterologous Booster Vaccinations With An MF59-adjuvanted, Cell Culture-derived H5N6 Influenza Vaccine in Adults Primed With MF59-adjuvanted, Cell Culture-derived H5N1 Influenza Vaccine or Unprimed PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89_18 in the <65 years of age cohort. The study investigates whether two priming doses of MF59-adjuvanted H5N1 cell culture-derived vaccine (aH5N1c) followed by one or two booster vaccinations with a MF59-adjuvanted H5N6 cell culture derived vaccine (aH5N6c) 3 weeks apart elicit immune responses to the antigens used for priming (H5N1) and boosting (H5N6) after first and second heterologous booster vaccination. Eligible subjects, ... |
SEQIRUS | 2022-07-18 |
| 301 | Yeast-derived Beta-glucan Supplementation on Antibody Response Following Influenza Vaccination: A Randomized, Placebo-controlled Study (M-Unity) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial in healthy adults will determine the effects of beta-glucan, a dietary fiber supplement isolated from baker’s yeast, on immune response to the influenza vaccine. |
UNIVERSITY OF FLORIDA | 2022-07-18 |
| 302 | Investigating The Inflammatory Cytokines and Cytokine Storm Among Bangladeshi Patients With COVID-19: A Prospective, Observational Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic by spreading up to 213 countries. Bangladesh is also facing its havoc with the death of 3000 among 229,185 cases at its 141st day. Most are mild cases presenting with influenza-like illness with expected recovery. According to World Health Organization, the overall global case fatality rate is currently estimated to be 2.9%. However, patients having severe or critical illness presenting with severe respiratory distress, … |
MONIRA SARMIN; | 2022-07-15 |
| 303 | A Phase III, Randomized, Double-blind and Controlled Clinical Trial to Evaluate The Immunogenicity and Safety of Influenza Vaccine, Inactivated, Quadrivalent Developed By Sinovac Biotech Co., Ltd. Compared to A Licensed Quadrivalent Influenza Vaccine, VaxigripTetra™, in Individuals Aged 3 Years and Older in Chile PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study compares the immunogenity and safety of quadrivalent inactivated influenza vaccines. The experimental group receives the quadrivalent influenza vaccine developed by Sinovac Biotech Co., Ltd and the control group immunized with Vaxigrip Tetra™. The group has 1600 persons from general population 3 years and older. The design is double-blind and randomized. The primary outcome is the immunogenicity against the 4 strains of influenza included in both vaccines. |
PABLO A GONZALEZ; | 2022-07-14 |
| 304 | A Phase Ⅲ, Randomized, Double-blind and Controlled Clinical Trial to Evaluate The Immunogenicity and Safety of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Individuals Aged 3 Years and Older in Chile PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and immunogenicity of Influenza vaccine (Split virion), Inactivated, Quadrivalent developed by Sinovac Biotech Co., Ltd. (Sinovac-QIV) as compared to a licensed comparator in Chile, Vaxigrip Tetra™ (Vaxigrip Tetra-QIV) in individuals aged 3 years and older. |
PABLO GONZÁLEZ; | 2022-07-14 |
| 305 | Proof of Concept Trial of Adjuvant Activity of SWE, A Squalene-based -Oil-in-water Emulsion Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to characterize safety and tolerability of the squalene-based adjuvant candidate SWE and its potential to enhance the immune response to seasonal influenza vaccine antigens in healthy older adults. |
BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE | 2022-07-14 |
| 306 | A Ph1 Randomized Double-Blind Controlled Dose-Range Safety Tolerability & Immunogenicity Study of 2 Doses of Intranasal RH5 Flu Vaccine With & Without Nanoemulsion Adjuvant Followed By 1 Boost of Intramuscular H5N1 Vaccine in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu. The study will be conducted in 40 healthy adults volunteers, age 18 – 45, in one center in the United States. The study will compare 3 different dose levels of rH5 (25µg, … |
JUSTIN ORTIZ; | 2022-07-07 |
| 307 | Randomized Controlled Trial Of A Health Belief Model-Based Intervention To Prompt To Take Up The Childhood Vaccines And Effect On Vaccination Attitudes PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to determine the effect of pregnant women aged 18 years and older who have completed their 28th week of pregnancy and received intervention based on the Health Belief Model, on encouraging childhood vaccinations and influencing their vaccination attitudes, compared to pregnant women who receive standard care group. The 12-month vaccination rate of newborns and the change in their attitudes will be determined according to the Public Attitude Towards Vaccination Scale – Health Belief Model. |
KÜBRA SULTAN DENGIZ; | 2022-07-04 |
| 308 | A Phase 1, Randomized, Rater and Subject Blinded Placebo Controlled Study to Evaluate The Safety, Reactogenicity, Tolerability and Immunogenicity of A Standard and A Fractional Dose of H1 Influenza Vaccine Delivered By VX-103 (a MIMIX Microneedle Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age |
VAXESS TECHNOLOGIES | 2022-07-02 |
| 309 | Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of The Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Influenza (flu) is a virus that infects people of all ages. Some people may have mild flu symptoms. Others may get very sick and even die from the flu. Flu vaccines help protect people against the flu, but if the flu strains in the vaccine are not a good match with the strains circulating in the community, … |
MATTHEW J MEMOLI; | 2022-06-27 |
| 310 | The Roles of Childhood Adversity and Inflammatory Reactivity in Promoting Pain and Fatigue After Provocation PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this observational study is to investigate how adverse experiences during childhood are linked to people experiencing persistent pain and fatigue in adulthood. The questions the investigators aim to answer are: 1. Does participant-reported childhood adversity predict levels of IL-6 and TNF-α after in vitro provocation of whole blood using endotoxin? 2. Do levels of IL-6 and TNF-α after in vitro immune provocation using endotoxin predict vulnerability to persistent pain and fatigue after in vivo immune provocation (tetravalent influenza vaccine)? 3. Do levels of IL-6 and TNF-α after in vitro immune provocation using endotoxin predict vulnerability to persistent pain and fatigue after in vivo neural provocation? For this study, the investigators will recruit and enrol 96 healthy human adults (18 – 65 years old) with a range of adverse experiences during childhood. Participants will attend 2 study sessions during which the investigators will take a sample of blood, assess pressure pain threshold before and after cold water immersion, assess heart rate variability, and assess the surface area of secondary skin hypersensitivity after electrical stimulation. At the end of the first session, participants will receive the influenza vaccination. |
VICTORIA MADDEN; | 2022-06-21 |
| 311 | Phase 1b Study to Investigate The Safety and Immunogenicity of Cam2020 (A/Cambodia/e0826360/2020) M2SR H3N2 Monovalent Influenza Vaccine Administered Alone or With Licensed, Inactivated Influenza Vaccine in Adults 65 to 85 Years Old PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult population age 65 to 85 years at time of enrollment. |
FLUGEN | 2022-06-14 |
| 312 | A Phase 3, Randomized, Stratified, Observer-blind, Active-Controlled Study to Evaluate The Immunogenicity and Safety of MRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against vaccine-matched influenza A and B strains at Day 29, and to evaluate the safety and reactogenicity of mRNA-1010. |
MODERNATX | 2022-06-06 |
| 313 | A Real-world Evidence Study of BNT162b2 MRNA Covid-19 Vaccine Among Children Aged 5 to 11 Years in Brazil PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences among children aged 5 to 11 years in the city of Toledo in Southern Brazil. Individuals aged 5 to 11 years who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 will be classified as cases, … |
REGIS G ROSA; | 2022-06-01 |
| 314 | Value of Platelet-Rich Plasma in Post Severe Acute Respiratory Syndrome Coronavirus 2 Smell Disorders PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The study will be conducted to evaluate : The efficacy of Platelet Rich plasma in treatment of smell disorders post severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via the growth factors involved in accelerating and enhancing healing. |
AYA ABDELNASSER HASSANI; | 2022-06-01 |
| 315 | Tropism and Pathogenesis of Influenza Virus and Coronavirus in Human Brain Explant Culture PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Influenza and coronavirus have been repeatedly causing pandemic recently. Like the Influenza A/H7N9 virus has caused five epidemics in China since its first detection in East China in 2013. In 2017, the previously low pathogenic avian influenza (LPAI) H7N9 virus underwent mutation in its haemagglutinin to give to a highly pathogenic avian influenza (HPAI) virus causing 32 human cases and potentially poses a threat to animal and human health. More recently, … |
OWEN HO KO; | 2022-05-26 |
| 316 | Study to Evaluate The Safety, Reactogenicity and Immunogenicity of Modified MRNA Vaccines Using A Systems Biology Approach in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines. |
MODERNATX | 2022-05-24 |
| 317 | Influenza Human Challenge Model PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study examines how the immune system responds to the flu virus (H3N2) during and after infection and how the flu virus is transmitted in the environment. The study will used a flu virus called the H3N2 influenza challenge virus which was produced specifically for use in clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy subjects. Mild to moderate symptoms are expected based on previous studies with this strain of influenza. |
NADINE ROUPHAEL; | 2022-05-24 |
| 318 | Evaluating The Effectiveness of An Intervention Involving Rapid Antigen Testing of Students for COVID-19 in Reducing Absences From Schools in Bangladesh PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this trial is to evaluate the impact of different testing strategies with Rapid Antigen Testing (RAT) on reduction of school absences. RATs are relatively inexpensive, fast, and can be performed at the point of care. Provision of testing in schools will allow rapid identification and isolation of individuals infected with Covid-19. This will likely reduce COVID-19 transmission, as well as allow symptomatic COVID-19 negative students to return to classroom, avoiding the 10-days isolation period. If proven successful, … |
ARIFA NAZNEEN; | 2022-05-18 |
| 319 | A Clinical Challenge Study to Evaluate Controlled Human Infection With BCG Administered By The Aerosol Inhaled Route in Historically BCG-vaccinated Healthy Adult Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the human clinical response to BCG challenge in historically BCG-vaccinated healthy adult volunteers. It will involve 12 participants in a controlled dose escalation. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity. |
HELEN MCSHANE; | 2022-05-17 |
| 320 | Phase 1/2, Randomized, Stratified, Observer-blind Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-1073 (SARS-CoV-2 and Influenza Vaccine) Compared to Co-administered MRNA-1010 (Influenza) and MRNA-1273 (SARS-CoV-2) Vaccines and to MRNA- 1010 Vaccine and MRNA-1273 Vaccine Alone in Healthy Adults 18-75 Years of Age PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants. |
MODERNATX | 2022-05-13 |
| 321 | Phase 2a, Randomized, Double-blind (Double-dummy), Controlled, Parallel-group Study to Evaluate The Immunogenicity and The Safety of The Concomitant Administration of OVX836 Influenza Vaccine and A Quadrivalent Inactivated Influenza Vaccine Given Intramuscularly As 2 Separate Injections in The Same Arm, in Comparison to Co-administration of Quadrivalent Inactivated Influenza Vaccine and Placebo and to Co-administration of OVX836 and Placebo Given Intramuscularly in Healthy Subjects PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest. |
ROSS ALDRICH; | 2022-05-09 |
| 322 | Prevalence, Genetic Risk Factor and The Use of Intradermally-administered Inactivated Influenza Vaccine With Topical Imiquimod in Influenza Vaccine Non-responsive Children PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Aims and hypotheses to be tested: Primary objective – To compare the IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders. Secondary objectives – To determine the IIV non-responder rate in healthy Hong Kong children. – To investigate the association between HLA molecules and IIV non-responsiveness. Hypotheses – The investigators hypothesize that among IIV non-responder children, … |
GILBERT CHUA; | 2022-04-30 |
| 323 | Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Raphamin in The Treatment of Coronavirus Disease 2019 in Outpatients PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Multicenter double-blind placebo-controlled parallel-group randomized clinical trial of efficacy and safety of Raphamin in the treatment of coronavirus disease 2019 in outpatients. |
OKSANA BELOUSOVA; | 2022-04-29 |
| 324 | A PHASE 1, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF SELF-AMPLIFYING RNA VACCINE PREPARATIONS AGAINST INFLUENZA IN HEALTHY INDIVIDUALS PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: – Are between the age of 18 to 49 years old. – Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. – Are healthy as determined by medical history, physical examinations, and the study doctor. – For male participants, … |
PFIZER | 2022-04-28 |
| 325 | Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe Cerebral Palsy (CP) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will pilot test a just-in-time (JIT) adaptive intervention to reduce severe respiratory illness, for children with severe cerebral palsy (CP). The intervention program, called RE-PACT, delivers timely, customized action planning and health coaching when mobile text messaging with families predicts hospitalization risk is elevated. A total of n=90 caregivers of children with severe CP will be enrolled from the University of Wisconsin-Madison (UW) and the University of California, Los Angeles (UCLA) and can expect to be on study for up to 6 months. |
RYAN COLLER; | 2022-04-27 |
| 326 | Randomized Double-blind, Placebo-controlled Single Center Pilot Study to Evaluate The Efficacy and Safety of Baloxavir in Combination With Oseltamivir in Adult Allogeneic Bone Marrow Transplant Recipients With Influenza Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, double-blind, placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. Although there are no data about this treatment option currently available, the investigator hypothesizes that combination therapy may be more effective in clearing influenza virus infection and decreasing the rate of emergence of resistant influenza in immunocompromised human hosts. |
MIRELLA SALVATORE; | 2022-04-22 |
| 327 | A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). – Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group – The duration of the study for each participant will be approximately 2 months – … |
BIONTECH SE | 2022-04-20 |
| 328 | Division of Microbiology and Infectious Diseases, (DMID) 21-0018: Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a double-blind randomized controlled trial to test whether the group B meningitis vaccine 4 component Neisseria meningitidis serogroup B vaccine (BEXSEROTM) (4C-MenB), trade name Bexsero™), currently approved for use by the United States Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) for protection from Neisseria meningitidis infections, … |
JOSEPH A DUNCAN; | 2022-04-18 |
| 329 | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE IN ADULTS ≥65 YEARS OF AGE PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination. |
PFIZER | 2022-04-11 |
| 330 | A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of A Monovalent MRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include: Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control. Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181 |
SANOFI PASTEUR A SANOFI COMPANY | 2022-04-11 |
| 331 | Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of The Safety, Tolerability, and Immunogenicity of Intramuscular CodaVax-H1N1 in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49 years. Participants will be enrolled in autumn 2022 (southern hemisphere) and followed through the 2022 influenza season (Part A) or enrolled in autumn 2023 and followed through the 2023 influenza season (Part B). Participants will be screened within 28 days of randomization, and eligible participants in Part A will be enrolled into 1 of 3 sequential cohorts and randomised to receive a single dose of CodaVax-H1N1, placebo (normal saline), … |
CODAGENIX | 2022-04-11 |
| 332 | Phase 1/2, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-1020 and MRNA-1030 Candidate Seasonal Influenza Vaccines in Healthy Adults PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1020, mRNA-1030, and mRNA-1010 vaccines against vaccine-matched influenza A and B strains. |
MODERNATX | 2022-04-06 |
| 333 | A Random, Double-Blind, Multicenter, Positive Control and Placebo Control Phase Two Trail to Evaluate The Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase two trail is to evaluate the immunogenicity of LAVI (non freeze- dried). The secondary objective is to evaluate the safety of LAVI (non freeze- dried). |
CHANGCHUN BCHT BIOTECHNOLOGY | 2022-04-01 |
| 334 | A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of MRNA-1345, An MRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With A Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given As An Open-label Boost at 1 Year Following A Primary Dose in Adults ≥ 50 Years of Age PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; … |
MODERNATX | 2022-04-01 |
| 335 | Assessment of Pulmonary Artery Pressure in COVID-19 Survivors Using Right Heart Catheterization PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Post COVID-19 pulmonary hypertension can develop as a result of lung parenchymal damage and altered pulmonary circulation induced by COVID-19 infection. It has been proposed that this type of PH should be considered a combination between PH of group 3 (due to interstitial fibrosis and alveolar inflammation) and 4 (induced by thrombotic/thromboembolic processes, endothelial injury, or, at least, hypoxic vasoconstriction). Right heart catheterization (RHC) is the gold standard for assessing pulmonary hemodynamics and is mandatory for confirming the diagnosis of pulmonary hypertension (PH), assessing the severity of hemodynamic impairment, and performing vasoreactivity testing in selected patients |
MOHAMED ABD ELMONIEM MOHAMED; | 2022-04-01 |
| 336 | Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for The Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT) |
ALLOVIR | 2022-03-21 |
| 337 | Clinical and Virological Characterization of Severe Acute Respiratory Infection Using PCR-Based Methods and Metagenomic Sequencing: A National Registry in Saudi Arabia PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: SARI is a major public health problem in Saudi Arabia and leads to considerable morbidity and mortality. Most SARI-related mortality occurs in patients admitted to ICUs across the country. RVIs alone and as precipitating causes of bacterial co-infections are under-recognized as causes of critical SARI. Therefore, data regarding the role of RVIs in critically ill patients with SARI in Saudi Arabia are greatly needed to fill the current gaps with respect to pathogens, disease pathogenesis, current treatment approaches, and clinical outcomes. In the VERIFY multicenter national registry, … |
YASEEN ARABI; | 2022-03-20 |
| 338 | Seasonal Influenza Vaccine Uptake Among Health Care Workers Following Awareness and Availability of Influenza Vaccine Supply in Tertiary Care Hospitals, Bangladesh PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: 1. Burden: Health-care workers (HCWs), such as doctors, nurses, and support staff involved in direct or indirect patient care, are at increased risk of influenza virus infections. HCWs may also transmit and spread influenza among hospitalized patients and other caregivers. HCWs often (40-83%) work while experiencing influenza-like illness (ILI), increasing the likelihood of influenza transmission to colleagues and patients. 2. Knowledge gap: Despite the World Health Organization recommendation for seasonal influenza vaccination among priority target groups such as health care workers, the low-income country such as Bangladesh lacks a seasonal influenza vaccination policy among this high-risk group, … |
INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH BANGLADESH | 2022-03-12 |
| 339 | Influenza-associated Pulmonary Aspergillosis (IAPA) in ICU Patients With Severe Influenza: Incidence and Host- and Pathogen Related Risk Factors PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza. |
JOOST WAUTERS; | 2022-03-10 |
| 340 | Improving Safe Antibiotic Prescribing in Telehealth: Evaluation of A Randomized Trial PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: Appropriate use of antibiotics reduces resistance and protects patients from unnecessary harm. Important advances in antibiotic stewardship have been achieved in outpatient settings, but little is known about stewardship in the rapidly growing telehealth sector. Prior pragmatic randomized trials have shown that Centers for Disease Control (CDC) Core Element interventions constructed using insights from decision and social psychology can greatly reduce inappropriate prescribing in outpatient settings. In a randomized trial, the investigators will adapt and test two aspects of CDC Core Elements in a telehealth environment (Teladoc®), … |
DANIELLA MEEKER; | 2022-03-03 |
| 341 | To Identify The Immunogenicity and Safety of Inavtivated Quadrivalent Influenza Virus Split Vaccine in Children Aged 3-8 Years With Two Doses and One Dose Pre-immunization PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study. Sample size and test grouping: In this study, a total of 360 subjects were enrolled in a self-controlled trial design. In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), … |
JIKAI ZHANG; | 2022-03-02 |
| 342 | Evaluation of The Prevalence and Antibiotic Susceptibility Pattern of Multidrug Resistance Bacteria and Its Association With Patients’ Predictive Factors PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: 1. To determine the prevalence of multidrug resistance bacteria in patient with different infections 2. To evaluate patients’ predictive risk factors of antimicrobial resistance 3. To assess the association between patients’ factors and prevalence of MDR bacteria |
ZAHRAA NAJAH MOHSIN; | 2022-03-01 |
| 343 | Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers in The Maternity Hospital of Nancy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Pertussis is a bacterial respiratory infection caused by Bordetella pertussis. Highly contagious, it is potentially serious and even fatal in infants under 6 months of age. The immunity acquired through vaccination is very limited in time, requiring regular booster shots. There is a passive protection of the newborn by the maternal-fetal transmission of maternal antibodies, … |
JEAN-MICHEL HASCOET; | 2022-03-01 |
| 344 | A Phase 2b Study to Assess The Effect of Dose Interval on The Effectiveness of A Protein-based Covid-19 Vaccine (Spikogen® Vaccine) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A study to assess the effect of varying the time interval between doses on the immunogenicity of an adjuvanted recombinant spike protein Covid-19 vaccine (Spikogen/Covax-19) |
DIMITAR SAJKOV; | 2022-03-01 |
| 345 | Phase 2a Study in Healthy Adult Participants Pre-treated With INNA-051 and Challenged With Influenza Virus PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in healthy adults, administered prior to administration of an influenza challenge virus. This study will evaluate 2 active dose levels of INNA-051 and placebo. |
VICTORIA PARKER; | 2022-02-28 |
| 346 | A Phase 1 Study in Healthy Participants to Evaluate The Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of The Influenza A Virus Replication Inhibitor CC-42344 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts. |
SAM SALMAN; | 2022-02-11 |
| 347 | A Phase 1, Open-label, Dose-escalation, First-in-human, Clinical Trial to Evaluate The Safety, Reactogenicity and Immunogenicity of The Investigational Seasonal Quadrivalent Influenza MRNA Vaccine CVSQIV Administered Intramuscularly in Healthy Younger and Older Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to evaluate the safety and reactogenicity profile of CVSQIV at different dose levels. |
CUREVAC | 2022-02-07 |
| 348 | Evaluation of The Effect of A Soluble Fiber Consumption on The Immune Response Post-influenza Vaccination in Healthy Subjects Aged 50 to 70 Years PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: At European level, the European Food Safety Agency has recognized two claims relating to the effects of prebiotics on the gastrointestinal sphere and on the immune system. In subjects aged 45-63, it was shown that a pre- … |
CEN BIOTECH | 2022-02-07 |
| 349 | Evaluation of An Interactive Risk Information Tool to Increase COVID-19 Vaccination Incidence in Vaccine-hesitant People During Omicron Wave in Germany PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Coronavirus (COVID-19) vaccines have saved millions of lives since release and remain a key tool in the fight against the pandemic. However, most countries have not reached the vaccine uptake rates needed to relieve pressure on hospitals and intensive care units (ICUs) during peak corona periods. Reduced effectiveness of vaccines in preventing infections with the Omicron variant and milder courses of the disease may trigger and support beliefs that vaccination is no longer necessary, especially among vaccine sceptics.The term ‘vaccine sceptic’, however, … |
ODETTE WEGWARTH; | 2022-02-03 |
| 350 | Impact of The Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on The Risk of Multiple Sclerosis Clinical Relapse or Clinical Worsening PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, … |
EDOUARD JANUEL; | 2022-02-03 |
| 351 | Linking Novel Diagnostics With Data-Driven Clinical Decision Support in The Emergency Department PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to validate the use of an electronic clinical decision support (CDS) tool, TriageGO with Monocyte Distribution Width (TriageGO-MDW), in the emergency department (ED). TriageGO-MDW is non-device CDS designed to support emergency clinicians (nurses, physicians and advanced practice providers) in performing risk-based assessment and prioritization of patients during their ED visit. This study will follow an effectiveness-implementation hybrid design via the following three aims (phases), … |
SCOTT LEVIN; | 2022-02-01 |
| 352 | Patient-Reported Outcomes Associated With COVID-19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Test-Confirmed Illness in The United States PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to understand: * the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses) * the potential effects of COVID-19 vaccines in people with COVID-19 This study will enroll participants who are: * 18 years or older * reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS pharmacy COVID-19 or influenza test sites. The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during multiple follow-ups over a 6-month period. |
PFIZER | 2022-01-31 |
| 353 | Immunogenicity of H. Influenzae Type B PRP-OMP Vaccines in American Indian and Alaska Native Children PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB. |
LAURA HAMMITT; | 2022-01-27 |
| 354 | Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating The Efficacy and Safety of AV5080 in Patients With Uncomplicated Influenza PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the efficacy of AV5080 versus Placebo based on time to symptom resolution in patients with uncomplicated influenza. |
VIRIOM | 2022-01-15 |
| 355 | Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization With Other Vaccines in Shanghai PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is an open clinical trial of the EV71 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co.,Ltd.The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), Inactivated co-administration with other vaccines |
LINLIN WU; | 2022-01-04 |
| 356 | A Multicenter Study Conducted to Evaluate The Performance of The LumiraDx SARS-CoV-2 & FLU A/B Test, and LumiraDx SARS-CoV-2 & RSV Test at Point of Care Testing Sites PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 & FLU A/B Test, and LumiraDx SARS-CoV-2 & RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation. |
RAMIN FARSAD; | 2022-01-04 |
| 357 | Influenza and The Heart: An Investigation Into The Acute and Lasting Cardiac Effects of Influenza Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Influenza and the Heart: An investigation into the acute and lasting cardiac effects of influenza infection the investigators aim to assess the mechanisms for cardiovascular disease in patients suffering an acute influenza infection. The project will be carried out by creating a prospective clinical cohort study of consecutive patients hospitalized at Herlev & Gentofte University Hospital with a laboratory confirmed influenza. |
TOR BIERING-SØRENSEN; | 2022-01-01 |
| 358 | The Effects of Probiotic Against Reducing Abundance of Human Papilloma Virus (HPV) in Women PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log colony forming unit (CFU)/day to reduce vaginal abundance of HPV in women compared to placebo via the use of vaginal self-swab. |
MIN-TZE LIONG; | 2021-12-27 |
| 359 | Interest of Plasma Exchange in Patients With Anti-interferon Type 1 Autoantibodies With Severe COVID-19 – PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: COVID-19 associated mortality remains high despite the advances in therapeutics such as dexamethasone. The severity of COVID-19 results from direct viral cytotoxicity, and the inflammatory response, which is associated with a hypercoagulable state, contribute to lethal hypoxemic pneumonia. During the SARS-CoV-2 replication phase, infected cells secrete chemokines and die by activating the immune system locally. A local inflammatory loop induces tissue destruction, which activates the immune system’s circulating cells, leading to another amplifying loop called the cytokine storm. In these phenomena, … |
MAZERAUD AURÉLIEN; | 2021-12-22 |
| 360 | Acute Respiratory Infections Global Outpatient Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the positivity rate of respiratory syncytial virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk participants presenting with acute respiratory infections (ARIs) in outpatient settings during the influenza/RSV season and to evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV. |
JANSSEN RESEARCH & DEVELOPMENT | 2021-12-20 |
| 361 | A Randomized, Double-blind, Placebo-controlled, Phase 2a Multiple Ascending Dose Study to Examine The Safety, Tolerability and Efficacy of AV-001 Injection in Patients Hospitalized With Pneumonia Due To COVID-19 or Other Respiratory Infections PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, … |
VASOMUNE THERAPEUTICS | 2021-12-20 |
| 362 | An Open Phase IV Clinical Trial of Quadrivalent Influenza Virus Split Vaccine to Evaluate The Safety and Immunogenicity in Healthy Population Aged 3-8 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures. |
LI ZHANG; | 2021-12-14 |
| 363 | Use of Wearable Sensors for Early Detection and Tracking of Viral Respiratory Tract Infections: The WE SENSE Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Viral respiratory tract infections (VRTI) are among the most common human illnesses, impacting billions globally. There is an unmet need to identify novel ways to detect, treat and prevent their spread. New wearable devices could address this need, using special biosensors worn by patients. This is a single centre, controlled, before and after, longitudinal, clinical trial. Participants will receive FluMist, a live attenuated influenza vaccine, … |
EMILY MCDONALD; | 2021-12-10 |
| 364 | A Phase III Randomized, Modified Double-blind, Active-controlled, Multi-center Study to Describe The Immunogenicity and Safety of The Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus A Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: – To describe the immune response induced by RIV4 and IIV4 in 18-49 and ≥ 50 years of age participants by hemagglutination inhibition (HAI) measurement method – To describe the safety profile of all participants in RIV4 and IIV4 groups |
SANOFI PASTEUR A SANOFI COMPANY | 2021-12-07 |
| 365 | PROmotion of COvid-19 VA(X)Ccination in The Emergency Department – PROCOVAXED PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this research is to increase COVID-19 and influenza vaccine acceptance and uptake in vulnerable populations whose primary (and often only) health care access occurs in emergency departments (ED Usual Source of Care Patients). Toward this goal, the investigators will conduct one on one interviews and focus groups with ED Usual Source of Care Patients and community partners and produce trusted messaging informational platforms (PROmotion of COvid-19 VA(X)ccination in the Emergency Department – PROCOVAXED) that will address barriers to COVID-19 and influenza vaccination, especially vaccine hesitancy. The investigators will then conduct a cluster-randomized, … |
ROBERT RODRIGUEZ; | 2021-12-06 |
| 366 | A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo or Oseltamivir Patients With Acute Uncomplicated Influenza A PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a multi-center, randomized, double-blind, placebo-controlled, and active controlled clinical trial to assess the efficacy and safety of ZSP1273 tablets in the treatment of Acute Uncomplicated influenza A. |
GUANGDONG RAYNOVENT BIOTECH | 2021-12-01 |
| 367 | A Randomized Controlled Trial Evaluating An Online Intervention Based on The Trans-Theoretical Model in Increasing Seasonal Influenza Vaccination Among Community Dwelling People Aged ≥65 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A non-blinded two-arm parallel randomized controlled trial will be conducted. Inclusion criteria are: 1) aged ≥65 years, 2) having Hong Kong ID, 3) Chinese speaking, 4) willing to be followed up by telephone, 5) having a smartphone, and 6) have not received SIV for the incoming flu season. Exclusion criteria include: 1) cognitive impairment, blindness or deafness, 2) not able to communicate with others effectively, and 3) with known contradictions of SIV (allergic to previous SIV, diagnosed/suspected egg allergy, … |
ZIXIN WANG; | 2021-12-01 |
| 368 | Assessment of The Immune Response to SARS-CoV-2/COVID-19 Vaccination in Patients With Sarcoidosis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines are highly efficacious in preventing COVID-19 in the general population, whether vaccination provides similar protection in people with sarcoidosis is unknown. The investigators hypothesize that people with sarcoidosis develop less robust antibody and cell-mediated immune responses to SARS-CoV-2 vaccination than healthy individuals, … |
PETER SPORN; | 2021-12-01 |
| 369 | A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study Evaluating Safety and Immunogenicity of Influenza A Hemagglutinin Stabilized Stem Nanoparticle Vaccine Candidate in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this Phase 1, single- center, randomized, double blind, placebo-controlled dose-escalation study is to evaluate the safety, tolerability and immunogenicity of UFluA vaccine candidate at two dose levels and two schedules in healthy adult (18-45-year-old, inclusive) male and non-pregnant female subjects. |
EMERGENT BIOSOLUTIONS | 2021-12-01 |
| 370 | A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness in An Urban and Suburban Population of Healthy Subjects Aged 18-55 Years, Not Vaccinated Against Influenza PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This Prospective epidemiological cohort study is being conducted in order to generate epidemiological data in support of Osivax’s clinical development of a broad spectrum influenza vaccine based upon the internal influenza nucleoprotein (NP) as a target for immune response. |
ISABEL LEROUX-ROELS; | 2021-12-01 |
| 371 | Quality of Life for Patients Who Are Treated Using Integrative Medicine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Integrative Medicine is an approach to health that addresses a person’s mental, physical, social, spiritual, and environmental factors. Chronic diseases are best treated if the root cause is addressed, improving one’s overall health. Health is defined by the WHO as a state of complete physical, mental and social wellbeing, and not merely the absence of disease or infirmity. Many national institutions, such as the American Heart Association, American College of Cardiology, American Diabetes Association, and more, all affirm that lifestyle modifications are the number one treatment and prevention for the most common disorders: high blood pressure, obesity, diabetes, high cholesterol, … |
AMBEREEN AHMED; | 2021-12-01 |
| 372 | Optimizing The Timing of Influenza Vaccination in Patients With Heart Failure: The FLU-HF Randomized Trial: A Randomized Controlled Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Heart failure (HF) is one of the most common causes of hospital admission in Canada and costs the Canadian healthcare system over $1 billion annually. Influenza vaccination is an inexpensive strategy to prevent influenza infections and reduce an important trigger for HF decompensation and hospital readmission. Yet, the optimal timing of vaccine administration remains unclear. When patients with HF are admitted to the hospital with an acute decompensation in advance of, or during, the ‘flu season’, this can be an ideal time to administer the vaccine. However, patients with acute HF decompensation have significant inflammatory injury, … |
ABHINAV SHARMA; | 2021-11-23 |
| 373 | Phase IV Clinical Study on Safety and Efficacy of Quadrivalent Influenza Virus Split Vaccine in Larger Population PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰. |
HUALAN BIOLOGICAL BACTERIN | 2021-11-17 |
| 374 | The SARS-CoV-2 Vaccine Response and Safety in Rheumatology Patients and The Influence of Temporary Interruptions in Immunomodulatory Therapy PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The COVID-19 VaccinE Response in Rheumatology patients (COVER) study is a multicenter randomized controlled trial designed to evaluate the efficacy and safety of a mRNA COVID-19 vaccine supplemental dose (booster) in patients with autoimmune conditions and to evaluate the impact of different immunomodulatory therapies on vaccine response. The investigators propose to recruit up to 1000- patients with autoimmune conditions who have a completed 2-dose regime of mRNA COVID-19 vaccine (>28 days prior) and who are planning to receive an additional dose of mRNA COVID-19 vaccine (i.e., … |
JEFFREY CURTIS; | 2021-11-15 |
| 375 | Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate The Immunogenicity and The Safety of One Single Administration of OVX836 Influenza Vaccine at Two Dose Levels (300μg and 480μg) Given Intramuscularly (IM), in Comparison to OVX836 Influenza Vaccine at 180μg and Placebo Given IM in Healthy Subjects Aged 18-55 Years and in Healthy Subjects Aged 65 Years and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 2a clinical trial is designed to evaluate the immunogenicity and the safety of one administration of OVX836 influenza vaccine at different dose levels (180µg, 300μg and 480μg) in order to assess the dose response of the OVX836 influenza vaccine. |
ISABEL LEROUX-ROELS; | 2021-11-15 |
| 376 | Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older. |
CECILE JANSSEN; | 2021-11-15 |
| 377 | Analysis of The Determinants of Refusal and Adherence to Coadministration of Influenza Vaccination With The Booster Dose of Anti-SARS-CoV-2 Vaccine Conducted on Health Care Personnel of The Fondazione Policlinico Universitario A. Gemelli IRCCS PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: Analysis of the determinants of refusal and adherence to the coadministration of influenza vaccination with the booster dose of anti-SARS-CoV-2 vaccine conducted on healthcare personnel of the University Polyclinic Foundation A. Gemelli IRCCS New evidence now suggests that co-administration of COVID-19 vaccines with inactivated vaccines is acceptable in terms of immunogenicity and reactogenicity (6). In particular, a recent randomized placebo-controlled phase IV study (7), established that both ChAdOx1 and BNT162b2 COVID-19 vaccines could be safely co-administered with seasonal influenza (SIV) vaccines adjuvanted with MF59 or derived from cell culture, … |
LAURENTI PATRIZIA; | 2021-11-13 |
| 378 | Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in The Elderly Aged 60 Years and Above PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above. |
ZHONGKUI ZHU; | 2021-11-13 |
| 379 | A Cluster Randomized Trial of Two Mask Systems (Acteev™ N95 + Acteev™ Fabric Masks Vs. Standard N95 + Fabric Masks During Shifts & in Community) in Preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) in HCWs PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: A cluster randomized trial will be conducted to evaluate the difference between an Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) and a standard system (standard N95 masks during shifts+ fabric masks in community) in preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2)in healthcare workers(HCWs). |
RAINA MACINTYRE; | 2021-11-13 |
| 380 | A Pilot Study of Dietary Taxifolin/Dihydroquercetin and Ergothioneine and Immune Biomarkers in Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The complexities of the immune system make measuring the impact of dietary interventions upon its function challenging. The immune system is highly responsive to environmental influences, including the diet. An individual’s diet provides the energy required to mount a strong and protective immune response, the building blocks required for synthesis of immune mediators such as antibodies and cytokines, and can also indirectly affect immune function via changes in the gut microbiome. Immune function varies across the lifecourse, with a well understood decline in immune function with age, … |
CAROLINE E CHILDS; | 2021-11-10 |
| 381 | Nivolumab, Ipilimumab and Radiation in Combination With Influenza Vaccine in Patients With Pancreatic Cancer (INFLUENCE) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Pancreatic cancer (PC) remains a dreadful disease due to its often advanced stage at diagnosis and poor sensitivity to chemotherapy. Progression after 1. line chemotherapy is inevitable in patients with advanced PC, and treatment options for patients who progress after 1. line chemotherapy are limited. Considering the emerging role of the tumor microenvironment, the combination of checkpoint blocking antibodies with immunomodulation of the tumor microenvironment could lead to better responses in tumor historically resistant to radiation and checkpoint blocking antibody approaches as single modalities. Influenza vaccination in cancer patients receiving immune checkpoint inhibitors resulted in a better survival, … |
INNA CHEN; | 2021-11-05 |
| 382 | Effectiveness of Pfizer-BioNTech BNT162b2 MRNA COVID-19 Vaccine on Symptomatic SARS-CoV-2 Infection and COVID-19-related Hospitalizations, Mortality, and Long-term Consequences in Brazil: A Real-world Evidence Study PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences following a mass vaccination campaign in the city of Toledo in Southern Brazil. Individuals aged 12 years or older who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 will be classified as cases, and those with negative PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of one year by means of structured telephone interviews. |
REGIS G ROSA; | 2021-11-03 |
| 383 | A Randomized, Double-blind, Phase 3 Study to Evaluate Safety, Reactogenicity, and Immunogenicity of Co-administration of Ad26.COV2.S and Influenza Vaccines in Healthy Adults 18 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone. |
JANSSEN VACCINES & PREVENTION B V | 2021-11-02 |
| 384 | Clinical Presentations and Outcomes of Patients With Covid-19 Pneumonia PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims at determining clinical presentations and outcomes of patients with covid-19 pneumonia and also follow up of patients for up to 6 months to detect possibility of post covid fibrosis |
GHADA MOHAMED BAHY; | 2021-11-01 |
| 385 | A Single-center, Randomized, Blinded, Positive Controlled Clinical Trial to Assess The Reactogenicity and Immunogenicity of A Quadrivalent Inactivated Influenza Vaccine in Healthy Participants Aged 6-35 Months PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: In this single-center, randomized, blinded, positive-controlled design, the investigators will assess the safety and immunogenicity of 2 doses of an inactivated quadrivalent influenza vaccine in children aged 6 to 35 months. About 120 healthy participants are planned to be enrolled, of who 60 participants were enrolled in the low-dose group and 60 participants were enrolled in the high-dose group. In the low-dose group, participants were randomly (2:1:1) assigned to receive a quadrivalent inactivated influenza vaccine (IIV4) at 0.25 mL including A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, and a trivalent inactivated influenza vaccine (IIV3) at 0.25 mL including A/H1N1, A/H3N2 and B/Victoria, … |
JIANGSU PROVINCE CENTERS FOR DISEASE CONTROL AND PREVENTION | 2021-10-26 |
| 386 | Efficacy and Safety of A Multistrain Probiotic Formula to Boost The Immune Response to Influenza Virus Vaccination PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Randomized clinical trial to determine whether a probiotic formulation containing 4 probiotic strains which belong to Lactiplantibacillus plantarum and Pediococcus acidilactici species can boost the immune response to influenza vaccination evaluated at 4 weeks in a population between 50 and 80 years of age. Secondary outcomes comprise evaluation of immune response at 8 weeks after vaccination, percentage of patients with seroconversion, incidence and duration of influenza-like infections and respiratory infections throughout a 4-month period and safety. |
AB BIOTICS SA | 2021-10-26 |
| 387 | Intralesional Influenza Vaccine for Patients With Melanoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This phase I trial investigates the effects of influenza vaccine in treating patients with stage I, II, and IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body. |
CARLO CONTRERAS; | 2021-10-20 |
| 388 | Impact of An SMS Reminder on Influenza Vaccination Coverage in Patients With Rheumatoid Arthritis Taking Anti-TNF : An Ancillary Study to The French National Registry ART E-cohort PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Biotherapies have significantly improved the prognosis of rheumatoid arthritis (RA), particularly anti-TNF. However, these molecules are associated with a well-demonstrated increase in infectious risk, including an over-risk of pneumococcal and influenza infection.. Therefore, when initiating anti-TNF treatments, it is recommended to update the vaccination schedule of these patients, to vaccinate them against pneumococcus and carry out an annual anti influenza vaccination.. However, vaccination coverage remains sub-optimal. The means to improve this vaccination coverage are multiple but often require human resources. Medical teams often lack time, … |
RAPHAELE SEROR; | 2021-10-19 |
| 389 | A Single Center, Randomized ,Controlled and Open Clinical Trial to Evaluate The Immunogenicity and Safety of The Booster Immunization With The Third Dose of COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a single center , randomized ,controlled and open-label phase Ⅳclinical trial of the booster immunization with the third dose of inactivated COVID-19 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the third dose of COVID-19 vaccine,inactivated (Vero Cell) co-administration with influenza vaccine and pneumococcal polysaccharide vaccine in healthy population aged 18 years and older. |
JIANG WU; | 2021-10-15 |
| 390 | COVID-19 Booster Vaccination in Persons With Multiple Sclerosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The success of the U.S. vaccination program against SARS-Cov-2 is shown by a dramatic drop in infection rates, hospitalizations and deaths.However, it appears that many persons who take medications that chronically suppress the immune system do not produce neutralizing antibodies to COVID-19 proteins in response to vaccination. This group includes a significant number of persons with multiple sclerosis (PWMS), … |
JOSEPH B GUARNACCIA; | 2021-10-15 |
| 391 | Improving Influenza Vaccination Delivery Across A Health System By The Electronic Health Records Patient Portal RCT 4 PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial is taking place in Los Angeles, CA at clinics within the UCLA Health System. The study design is a 2×2 nested factorial design. Patients will be randomized into 1) receiving text based reminder messages, 2) portal-based reminder messages or 3) the control group. Patients randomized to the intervention arms will receive reminders if they are due for influenza vaccine. Nested within the reminder arms (text or portal), … |
PETER G SZILAGYI; | 2021-10-14 |
| 392 | Point-of-care Ultrasound for The Diagnosis and Risk Stratification of Lower Respiratory Tract Infections in TB Endemic Regions: A Multicenter Prospective Cohort Study PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: In Sub-Saharan Africa, lower respiratory tract infections (LRTIs) and tuberculosis (TB) jointly are the leading cause of overall mortality. There is a need to integrate sustainable triage and management strategies into standard care. The TrUST study investigates the utility of point-of-care ultrasound (POCUS) for diagnosis and prognosis of LRTIs in TB endemic regions in the outpatient triage setting. Automated interpretation of POCUS by artificial intelligence (AI) may further standardize and improve its predictive utility as well as facilitate its implementation into usual practice. |
BOILLAT-BLANCO NOEMIE; | 2021-10-14 |
| 393 | Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During The Influenza Season 2021/22 PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22. The secondary objectives of the study are: – To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups. – To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period. – … |
SANOFI PASTEUR A SANOFI COMPANY | 2021-10-12 |
| 394 | Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an antiviral drug that blocks enzymes on the surfaces of influenza viruses, interfering with cell release of complete viral particles. Giving baloxavir in combination with oseltamivir may shorten or decrease the intensity of influenza infection compared to oseltamivir alone. |
ROY F CHEMALY; | 2021-10-11 |
| 395 | An Exploratory Clinical Trial to Evaluate The Immunogenicity and Safety of One Vs Two Doses of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children. |
HONGXING PAN; | 2021-10-10 |
| 396 | Clinical Observation of Combined Immunization of COVID-19 Inactivated Vaccine With Quadrivalent Influenza Vaccine(QIV) and 23-valent Pneumococcal Polysaccharide Vaccine PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The main objective of this study was to evaluate the immunogenicity and safety of the booster dose of COVID-19 inactivated vaccine and co-immunization with quadrivalent influenza vaccine and 23-valent pneumonia polysaccharide vaccine in people aged 18 years and older. A randomized controlled, open trial design was adopted. The study was conducted with informed consent of the subjects for immunogenicity and safety in the population aged 18 years and older. A total of 3000 healthy subjects were selected, (1)600 healthy subjects were selected for the immunogenicity and safety study of co-immunization, … |
WU JIANG; | 2021-10-08 |
| 397 | A Phase III, Randomized, Open-label, Controlled, Multicenter Study to Evaluate The Immune Response and Safety of Both Herpes Zoster Subunit Vaccine in Healthy Adults Aged 50 Years and Older AND The Influenza Virus Vaccine in Healthy Adults Aged 18 Years and Older When Administered Sequentially or Coadministered With MRNA-1273 Booster Vaccination PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to evaluate the immune response and safety of both GlaxoSmithKline Biologicals SA’s (GSK’s) herpes zoster (HZ) subunit (su) vaccine in healthy adults 50 years of age (YOA) and older and quadrivalent seasonal influenza (Flu D-QIV) vaccine in healthy adults 18 YOA and older, when administered sequentially or co-administered with Moderna’s mRNA-1273 booster vaccination against COVID-19. |
GLAXOSMITHKLINE | 2021-10-07 |
| 398 | Influenza Vaccination During COVID19 Outbreak After Acute Coronary Syndrome and Chronic Heart Failure PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Study Description: Background: Well-known fact that the number of cardiovascular diseases is on the rise during influenza epidemic. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. A number of studies have shown that the risk of cardiovascular complications (ACS, stroke, CHF decompensation, … |
DMITRY DUPLYAKOV FESC; | 2021-10-06 |
| 399 | A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate The Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately. |
JANSSEN VACCINES & PREVENTION B V | 2021-10-04 |
| 400 | Safety of Simultaneous Versus Sequential Administration of MRNA COVID-19 Vaccines and Quadrivalent Inactivated Influenza Vaccine (IIV4) in Adults and Adolescents: A Randomized Observer Blinded Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID vaccine either simultaneously or sequentially, 14 days apart. A second dose of mRNA COVID vaccine will be administered either 3 or 4 weeks following the first dose, depending upon the mRNA COVID vaccine received for participants receiving their initial dose of mRNA COVID vaccine. For those receiving a third dose of mRNA COVID vaccine, … |
EMMANUAL B WALTER; | 2021-10-04 |
| 401 | Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine Vs. Standard-Dose Quadrivalent Influenza Vaccine in A Pragmatic Registry-Based Setting PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to assess the feasibility of identifying, recruiting and randomizing a large sample of Danish citizens aged 65-79 years to high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine in the 2021/2022 influenza season in a registry-based setting using Danish nationwide registries for all data collection including baseline information and outcome assessment. |
TOR BIERING-SØRENSEN; | 2021-10-01 |
| 402 | Effect of One-week Vs Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a multi-center, randomized, single-blinded, prospective, parallel group intervention study to investigate whether methotrexate (MTX) discontinuation for 1 week is non-inferior to MTX discontinuation for 2 weeks in regard to satisfactory vaccination response to a seasonal influenza. |
SEOUL NATIONAL UNIVERSITY HOSPITAL | 2021-10-01 |
| 403 | Do Far-UVC Light Devices Reduce The Incidence of Influenza-Like Illnesses, Respiratory Illnesses, and COVID-19 Infections in Long-term Care Facilities? PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Elderly people who have multiple health problems are at higher risk of illness from viral respiratory infections, such as influenza (the flu) and COVID-19. This is especially true for residents in long-term care because the usual methods of infection control (handwashing, mask-wearing, and distancing) are difficult to enforce due to the memory problems of many residents and the frequently shared common spaces. It can also be difficult to prevent the spread of viral infections within long-term care because many residents are unable to tell their caregivers when they are feeling ill. Also, … |
KENNETH ROCKWOOD; | 2021-10-01 |
| 404 | A Multicenter, Randomized, Double-blind, Placebo-сontrolled Comparative Study to Evaluate The Safety, Tolerability and Efficacy of XC221 Used at 100 Mg Daily and at 200 Mg Daily in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A multicenter, randomized, double-blind, placebo controlled comparative study to evaluate the safety, tolerability and efficacy of XC221 used at 100 mg daily and at 200 mg daily in patients with uncomplicated influenza or other acute viral upper respiratory infections (URIs) for 5 days of treatment. The primary objective of the study is to evaluate the efficacy of ХС221 at 100 mg and at 200 mg in comparison with placebo regarding its effect on the severity and duration of influenza symptoms and symptoms of other viral URIs (fever and other major signs and symptoms). The secondary objective of the study is to evaluate the safety of ХС221 at 100 mg and at 200 mg in comparison with placebo in the treatment of influenza ad other viral URIs. |
VALENTA PHARM JSC | 2021-10-01 |
| 405 | COVID-19: A Phase 3, Randomized, Observer-blinded, Multicenter Clinical Study Evaluating The Immunogenicity, Safety, and Reactogenicity of The Investigational SARS-CoV-2 MRNA Vaccine CVnCoV, When Co-administered With A Licensed Quadrivalent Influenza Vaccine Versus Separate Administration of The Two Vaccines in Adults 60 Years of Age and Older Related Papers Related Patents Related Grants Related Experts View Highlight: The most recently discovered coronavirus (SARS-CoV-2) may cause illness in humans ranging from the common cold to serious illness, also referred to as Coronavirus disease 2019 (COVID-19). As of January 2021, … |
BAYER | 2021-10-01 |
| 406 | A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of An MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comparison With A Licensed Quadrivalent Influenza Vaccine, in Adults 50 to 64 Years of Age PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age. The aim of the study is to demonstrate a noninferior immune response for aQIV versus the comparator vaccine for all four vaccine strains, and a superior immune response for at least two of the four vaccine strains. |
SEQIRUS | 2021-09-30 |
| 407 | Evaluation of The Vaccination Coverage in A Prospective Cohort of Cirrhotic Patients Followed in The General Hospitals in France in 2021 and in 2022 PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the |
CENTRE HOSPITALIER SUD FRANCILIEN | 2021-09-27 |
| 408 | Natural History of Systemic and Nasal Mucosal Immunity After Influenza Vaccination in A Pediatric Population PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: The influenza (flu) virus infects millions around the world every year. Children are at increased risk of complications from the flu. The flu vaccine protects against influenza, … |
ALISON HAN; | 2021-09-24 |
| 409 | A Multicenter, Double-blind, Randomized, Placebo-controlled Study of The Efficacy and Safety of Ingavirin®, Syrup, 30 Mg/5 Ml, in Children Aged 6 Months to 2 Years With Influenza and Other Acute Respiratory Viral Infections Against Standard Therapy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, syrup, 30 mg/5 ml, in the treatment of influenza or other acute respiratory infections in children from 6 months to 2 years compared with placebo. |
VALENTA PHARM JSC | 2021-09-23 |
| 410 | Effect of Protons Versus Photons on Immunological Function in Head and Neck Cancer: A Pilot Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a pilot prospective observational cohort study, comprising patients with head and neck cancer (HNSCC) treated with standard of care definitive (chemo)radiation either with photons or protons. Patients will be assigned for protons or photons based on the guidelines of the National Indication Protocol for Proton therapy of the Netherlands. Immunological function will be evaluated by the collection of peripheral blood mononuclear cells (PBMCs). Blood samples will be collected at baseline, during (chemo)radiation (end of week 3 and/or before week 4 of treatment) and after completion of (chemo)radiation (week 9, week 12, week 20, week 34 and week 60, … |
UNIVERSITY MEDICAL CENTER GRONINGEN | 2021-09-23 |
| 411 | Safety of Simultaneous Vaccination With Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Inactivated Influenza Vaccine (aIIV4) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The overall aim of the study is to compare the safety of simultaneous RZV (SHINGRIX®) and inactivated adjuvanted influenza vaccine aIIV4 (FLUAD®) versus simultaneous RZV (SHINGRIX®) and inactivated influenza HD-IIV4 (Fluzone® HD) vaccine in persons ≥65 years. A prospective, randomized, blinded clinical trial that will be conducted during the 2021/2022 and 2022/2023 influenza seasons. Over the course of these two influenza seasons, approximately 220 older adults will be enrolled at Duke University Medical Center, … |
KENNETH SCHMADER; | 2021-09-21 |
| 412 | A Random, Double -Blind, Placebo Control Phase Ⅰ Trail to Evaluate The Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried). |
CHANGCHUN BCHT BIOTECHNOLOGY | 2021-09-20 |
| 413 | Exploratory Study Into Age-related Immunological Differences Related to Immunogenicity in Influenza Vaccination and Herpes Zoster Vaccination PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Vaccines are used to prevent infectious diseases worldwide. Unfortunately, many vaccines, like the flu vaccine, are less effective in older adults. This single-centre open label partially randomised, partially placebo-controlled trial evaluates the differences in immune response between young and older adults after vaccination with a quadrivalent inactivated influenza vaccine and an adjuvanted herpes zoster vaccination. Exploring the underlying mechanisms between the differences in immunogenicity can provide important information for future vaccine development. |
JAAP TEN OEVER; | 2021-09-20 |
| 414 | A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of An Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, … |
FANGYUE MENG; | 2021-09-19 |
| 415 | A Phase III, Randomized, Multi-country Study to Evaluate The Lot-to-lot Consistency of GSK’s Investigational RSV Maternal Vaccine and The Immune Response, Safety and Reactogenicity of RSV Maternal Vaccine When Co-administered With GSK’s Quadrivalent Influenza D-QIV Vaccine in Healthy Non-pregnant Women 18-49 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK’s quadrivalent seasonal influenza (Flu D-QIV) vaccine. |
GLAXOSMITHKLINE | 2021-09-15 |
| 416 | The Shandong Provincial Center for Disease Control and Prevention, China PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this [To evaluate the immunogenicity and safety of 1 – and 2-dose schedules of quadrivalent influenza vaccine (split virion) in healthy people with and without immunization history.] is to [aged 3-8 years] in [Healthy people]. The main question[s] it aims to answer are: • [To evaluate the immunogenicity of a two-dose schedule of quadrivalent influenza vaccine (quadrivalent influenza vaccine) in healthy population aged 3-8 years with or without vaccination history.] •[ To evaluate whether antibody levels are different 30 days after one dose of quadrivalent influenza vaccine versus two doses of quadrivalent influenza vaccine in healthy people aged 3-8 years with or without vaccination history.] |
HUALAN BIOLOGICAL BACTERIN | 2021-09-15 |
| 417 | A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA IN HEALTHY INDIVIDUALS PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will be divided into two substudies – Substudy A (SSA) and Substudy B (SSB) Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either: – 1 of 4 dose levels of mIRV (either A or B Strain), – 1 of 4 dose levels of bIRV (containing both A and B strains), – … |
PFIZER | 2021-09-13 |
| 418 | A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of AnInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, … |
JIANGSU PROVINCE CENTERS FOR DISEASE CONTROL AND PREVENTION | 2021-09-11 |
| 419 | A Phase 1b, Double-Blind, Randomized, Dose-Escalating, Age De-Escalating, Placebo-Controlled Study to Assess The Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine Delivered Intranasally In A Healthy Pediatric Population 6 Months Through 17 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1b, randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled study of 200 children, ages 6 months to 17 years. This clinical trial is designed to assess the safety, tolerability/reactogenicity, and immunogenicity of one and two doses of Sing2016 M2SR H3N2 influenza vaccine (manufactured by FluGen) administered intranasally in seven cohorts of children. The first two groups to be vaccinated will be Cohorts 1 and 2. Cohort 1 consists of 45 children 9-17 years old. Thirty of them will receive one dose of the vaccine at a dose of 10^9 TCID50, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2021-09-10 |
| 420 | Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: The study team previously demonstrated that patients are more likely to receive flu vaccine after learning that they are at high risk for flu complications. Building on this past work, … |
MICHELLE N MEYER; | 2021-09-09 |
| 421 | A Phase 1/2, Randomized, Observer-Blinded Study to Evaluate The Safety and Immunogenicity of A Quadrivalent Hemagglutinin Nanoparticle Influenza and SARS-CoV-2 RS Nanoparticle Combination Vaccine With Matrix M1™ Adjuvant in Healthy Participants ≥ 50 to ≤ 70 Years of Age PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine. |
NOVAVAX | 2021-09-08 |
| 422 | Collection of Serum Samples From Children 6 Months to < 9 Years of Age Who Received Fluzone® Quadrivalent and Adults ≥ 65 Years of Age Who Received Fluzone® High-Dose Quadrivalent, Influenza Vaccines, 2021-2022 Formulations PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process. |
SANOFI PASTEUR A SANOFI COMPANY | 2021-09-08 |
| 423 | Lottery Incentive Nudges to Increase Influenza Vaccinations PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: In the current study, the study team will explore whether small incentives are effective at promoting flu vaccine uptake. The study is designed to compare the relative efficacy of incentives of equal perceived expected value (EV) or equal implementation costs, to assess whether people are more likely to get vaccinated in response to lotteries with very high payoffs than to small certain cash payout or slightly higher-probability, more moderate payoffs. In particular, given the potential appeal of official state lottery tickets, … |
MICHELLE N MEYER; | 2021-09-04 |
| 424 | Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in Adolescents With Type 1 Diabetes: A Prospective Observational Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Adolescents with type 1 diabetes may be at increased risk for severe coronavirus disease-2019 (COVID-19) and are therefore prioritized for access to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. The pivotal trial that assessed the efficacy of the BNT162b2 vaccine among adolescents demonstrated 100% protection against SARS-CoV-2 infection after a two-dose regimen. However, the research did not include adolescents with type 1 diabetes. In this study, … |
HAMDI CIHAN EMEKSIZ; | 2021-09-03 |
| 425 | Clinical Study on Immunogenicity and Safety of Recombinant Novel Coronavirus（COVID-19）Vaccine (CHO Cell) Combined With Tetravalent Influenza Virus Lysis Vaccine in People Aged 18 Years and Over PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Popular topic：Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Overall design:An open experimental design was adopted in this study, … |
TAO HUANG; | 2021-09-03 |
| 426 | The Impact of The Qatar 2022 FIFA World Cup During Winter Epidemics on Paediatric Emergency Department Use and Misuse Patterns: A Multicentre, Retrospective, Population-based Study PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: A retrospective cohort study to explore the impact of the FIFA World Cup 2022 Qatar on paediatric emergency department attendance at two tertiary centres during unprecedent winter viral epidemics. |
JOHAN SIEBERT; | 2021-09-01 |
| 427 | Development and External Validation of A Prediction Model for Critical Outcomes of Patients With Confirmed COVID-19 in The Hospital Setting Based on Demographic Characteristics, Medical Conditions and Oral Health PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The study aims to develop and externally validate a prediction model for the critical outcomes of COVID-19 patients using predictors which can be easily obtained in clinical practice, including patients’ demographic characteristics, self-reported medical conditions, and oral health. |
NAICHUAN SU; | 2021-09-01 |
| 428 | Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study evaluates the association between gut microbiome and dietary determinants and vaccine response. This study aims to learn if diet and the microbes (such as bacteria and viruses) found in your gut affect the body’s immune response to the influenza vaccine. |
JENNIFER WARGO; | 2021-08-24 |
| 429 | An Observational Pharmacokinetic Study of Intravenous Voriconazole Used for Treatment of Invasive Aspergillosis in Adult Patients With Severe Influenza / COVID-19 Supported With Extra-corporeal Membrane Oxygenation (ECMO) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Given the high burden of fungal co-infection in patients admitted to ICU and improved outcomes with prompt anti-fungal treatment, it is of vital importance that the doses of anti-fungal are optimum to improve the dismal outcome of influenza/Covid-19 Associated Pulmonary Aspergillosis. Due to the reported difficulties in dosing appropriately in ECMO patients, a prospective observational study is required to accurately evaluate the pharmacokinetics of voriconazole in patients supported on ECMO. This is to ensure that the dose of voriconazole is optimised to improve efficacy and reduce toxicity. |
HAKEEM YUSUFF; | 2021-08-24 |
| 430 | A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate The Potential Effect of Tezepelumab on The Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous [SC] every 4 weeks [Q4W]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022 in the USA. |
ASTRAZENECA | 2021-08-23 |
| 431 | A Multicenter, Blinded, Randomized, Placebo-Controlled, Dose-Ranging Influenza Challenge Study in Healthy Adult Volunteers to Determine The Optimal Infection Dose and Safety of A Recombinant H3N2 (A/Texas/71/2017 (H3N2), Clade 3C3a) Influenza Challenge Virus PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: An open-label, dose-ranging influenza challenge study in healthy adult volunteers to determine the optimal infection dose and safety of a recombinant H3N2 (A/Texas/ A/Texas/71/2017 (H3N2, clade 3C3a) influenza strain. The goal of this study is to find a challenge virus dose that is safe and can achieve a symptomatic influenza Attack Rate (AR) that will be sufficiently high for utilization in future vaccine or intervention studies. The optimal dose of the three considered is broadly defined as the minimum challenge virus dose that elicits the highest AR without meeting safety-stopping criteria. Additionally, viral recovery, clinical symptoms, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2021-08-16 |
| 432 | Selenium As A Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Given its anti-viral, anti-oxidative, immune-enhancing, cytokine-modulating, and anticoagulant properties, the investigators hypothesize that Selenium infusion at supranutritional doses for moderately-ill, severely-ill, and critically-ill COVID-19 patients will prevent further clinical deterioration thus decreasing overall mortality and improving survival. To test this hypothesis, a prospective, single-center, phase II trial is proposed to assess the efficacy of Selenium in hospitalized adult patients with moderate, severe, and critical COVID-19 infections. |
MOHAMED GHOWEBA; | 2021-08-15 |
| 433 | Effect of A Fermented Soy Product on Cognition, Immune Status and Response to Influenza Vaccine in Elderly Men and Women PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The research study will test the effects of Q CAN PLUS powder on the immune, inflammatory and cognitive functions. |
JOAN SABATE; | 2021-08-12 |
| 434 | Effect of Daily Consumption of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Middle -Aged Men: A Randomized Controlled Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men |
JOAN SABATE; | 2021-08-12 |
| 435 | Comparative Effectiveness of Baloxavir Versus Oseltamivir for Influenza Outbreak Management in U.S. Nursing Homes PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Influenza outbreaks are a prevalent event in nursing homes (NHs). We will study baloxavir compared to oseltamivir when used for influenza prophylaxis when facilities identify an index incident case of influenza. This study will help guide nursing home’s decision making and demonstrate the effectiveness of a novel antiviral for preventing influenza outbreaks. |
H E DAVIDSON; | 2021-08-06 |
| 436 | Isotretinoin in Treatment of COVID-19 (Randomized) PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 Mahmoud ELkazzaz(1),Tamer Haydara(2), Mohamed Abdelaal(3), Abedelaziz Elsayed(4) ,Yousry Abo-amer(5), Hesham Attia(6), Quan Liu(7)’ Tim Duong(8) and Heba Sahyon(9) 1. Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt. 2. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt 3. Department of Cardiothoracic Surgery, Faculty of Medicine, Kafrelsheikh University, Egypt 4. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Tanta University, Egypt. 5. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt 6. Department of Immunology and Parasitology, Faculty of Science, Cairo University, … |
MAHMOUD RAMADAN MOHAMED ELKAZZAZ; | 2021-08-01 |
| 437 | Post-marketing Safety Evaluation of 10 or 13-valent Pneumococcal Conjugate Vaccine in Children and 23-valent Pneumococcal Polysaccharide Vaccine in Elderly Adults PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this observational study is to examine the risk of adverse events following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age <59 months and 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults age 65 years and older. |
JU-YOUNG SHIN; | 2021-08-01 |
| 438 | One-health Approach in Epidemiological Investigation of SARS-CoV-2 in Laos PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The Respiratory infection COVID-19, due to a new coronavirus, SARS-CoV2, appeared in December 2019 in several people who attended the wildlife market in Wuhan, Hubei Province, China. While COVID-19 has spread to nearly 200 countries and caused two millions infections, Lao PDR detected its first confirmed case very recently, on March 20, three months after the start of the outbreak in China. As of April 12th, 2020, Lao PDR has only recorded 18 confirmed cases, a very low number compared to other countries around the world. However, … |
PHIMPHA PABORIBOUNE; | 2021-08-01 |
| 439 | Evaluation of The Efficacy of Triazavirin Versus Oseltamivir in Egyptian Patients Infected With Coronavirus Disease 2019 (COVID-19) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to evaluate the efficacy and safety (side effects and / or adverse effects) of Triazavirin and Oseltamivir as treatment of Coronavirus Disease 2019 in Egyptian patients in military hospitals. |
AMAL A. ELKHOLY; | 2021-08-01 |
| 440 | Hematological Disorders Associated With COVID-19 Infection PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The emergence of the Coronavirus Disease -19 (COVID-19) pandemic, has had a tremendous global impact, resulting in substantial morbidity and mortality worldwide. Although involvement of the lower respiratory track accounts for most of the morbidity and mortality seen, the virus involves several organ systems and the syndrome exhibits clinical diversity with a wide range of symptoms and manifestations. Aim of this study is to evaluate if there is a casual relationship between the development of aplastic anemias& other immune cytopenias, and recent COVID-19 infection. |
MAI ALI ABDELFATAH AHMED; | 2021-08-01 |
| 441 | Enhancing COVID-19 Vaccination Intentions By Eliciting Prosocial Altruistic Motives: Evaluating The Efficacy of A Brief Video-Based Intervention PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: As Canada records over 1,400,000 COVID-19 infections and 26,000 deaths, the need to stop the spread of the virus has become increasingly critical. Although younger individuals (aged 20-39) have lower hospitalisation and death rates than older adults, they have high rates of infection and may be less willing to accept a vaccine because they consider the disease to be less dangerous for themselves. It is of concern that around 30% of Canadians, especially younger adults, … |
ZEEV ROSBERGER; | 2021-07-30 |
| 442 | Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for The Treatment of Lassa Fever: A Randomized Controlled Open Label Phase II Clinical Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This exploratory, prospective, controlled, multisite, open label, randomized clinical trial with two treatment arms aims to compare favipiravir, a new treatment candidate for Lassa fever (LF), with the current standard of care, ribavirin. The primary endpoints of this research are (1) the description of classical pharmacokinetic parameters of favipiravir in comparison with ribavirin standard treatment in patients suffering from LF and (2) the safety and tolerability of both study drugs in the investigated regimens. |
PETER AKHIDENO; | 2021-07-30 |
| 443 | A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Historically, health disparities in the US are concentrated among underserved communities and socially vulnerable populations. The disproportionate COVID-19 related morbidity and mortality in communities of color and socioeconomic disadvantage acutely highlight this persistent public health problem, drawing attention to the urgent need for more equitable reach of testing, prevention, and control measures. The proposed research addresses this need using a 2-arm randomized controlled trial (RCT) that will evaluate the effectiveness of the Nurse-Community Health Worker (CHW)-Family Partnership intervention in promoting COVID-19 testing uptake, adoption of COVID control measures, … |
VINCENT M GUILAMO-RAMOS; | 2021-07-23 |
| 444 | A Phase II, Open-label Study to Assess The Safety and Immunogenicity of Fluzone® High-Dose Quadrivalent (Influenza Vaccine), 2021-2022 Formulation and A Third Dose of Moderna COVID-19 Vaccine (mRNA-1273 Vaccine) Administered Either Concomitantly or Singly in Adults 65 Years of Age and Older Previously Vaccinated With A 2-dose Schedule of Moderna COVID-19 Vaccine PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65 years of age and older having received their second dose of the 2-dose schedule of Moderna COVID-19 vaccine at least 5 months before enrollment in the study. |
SANOFI PASTEUR A SANOFI COMPANY | 2021-07-16 |
| 445 | CONNECTS Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue) PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. |
SEAN COLLINS; | 2021-07-15 |
| 446 | Safety and Efficacy of ALLOSTIM® Universal Anti-Viral Immunodulatory Vaccine for Healthy Elderly Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This protocol tests the safety and efficacy of a novel universal vaccine concept called allo-priming which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses. |
NICOLE THOMAS; | 2021-07-12 |
| 447 | Observational, Prospective Cohort Study of The Immunogenicity and Safety of SARS-CoV-2 Vaccines Administered During Pregnancy or Postpartum and Evaluation of Antibody Transfer and Durability in Infants PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from pregnant individuals and postpartum individuals and their infants following maternal receipt of licensed or Emergency Use Authorization (EUA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. |
FLOR MUNOZ; | 2021-07-06 |
| 448 | A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine. |
MODERNATX | 2021-07-06 |
| 449 | Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver （CQMU） PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), … |
HONG REN; | 2021-07-01 |
| 450 | Ivermectin Versus Standard Treatment in Mild COVID-19: A Prospective Cohort Study PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Rationale: Ivermectin, an inexpensive and available antiparasitic drug, with favourable safety profile, showed inhibitory effect on SARS-CoV2 viral replication in-vitro and in animal models. Several research groups investigated Ivermectin in COVID-19, particularly in mild symptomatic disease. There is high degree of uncertainty on its effects on clinical outcomes and larger studies are needed. Objectives: Plan to study the effect of Ivermectin versus standard treatment in patients with confirmed mild COVID-19. Study design: Multi-centre prospective cohort study Settings: Assiut University Hospital (Assiut University), Aswan and others, … |
ALIAE AR MOHAMED HUSSEIN; | 2021-07-01 |
| 451 | Phase 1b Clinical Study to Investigate The Safety and Immunogenicity of The Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years. |
FLUGEN | 2021-06-30 |
| 452 | Study of Lymphopenia As A Specific Biomarker or Prognostic Risk Factor for Disease Severity in Elderly Patients With COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Lymphopenia is reported to be associated with the severity of disease progression in COVID-19. Low lymphocyte count is also associated with increasing age. No study has yet investigated the effects of lymphopenia in this disease on the outcome in elderly people. Objectives: To assess the outcome of lymphopenia in elderly patients having COVID-19 and its usefulness as prognostic factor in elderly people. Methods: Retrospective cohort study. Clinical data (medical history, comorbidities, treatments, … |
NATHALIE COMPTÉ; | 2021-06-30 |
| 453 | Study of The Expression of Angiotensin-converting Enzyme 2 (ACE2), A Cell Membrane Receptor for SARS-CoV-2 and The TMPRSS2 Serine Protease in Tonsils and Adenoids of Children and Adults Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of the research is to study the expression of the ACE 2 receptor and the TMPRSS2 serine protease in the tonsils and adenoids of children and adults. |
ROMAIN LUSCAN; | 2021-06-30 |
| 454 | Using Telemedicine, Remote Physiologic Monitoring, and Mobile Self-reported Symptom Surveys to Improve Care for COVID-19 Patients PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study seeks to evaluate how secondary data retrieved from remote physiological monitoring performed during routine outpatient/at-home care periods can allow for the discovery of novel physiomarkers that predict acute deterioration or hospitalization among people testing positive for Coronavirus Disease 2019 (COVID-19). |
BLAKE ANDERSON; | 2021-06-25 |
| 455 | The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will develop and test an intervention, called OPTIMIZE, which includes the use of a perinatal checklist by clinic staff and provision of patient navigation support to African American pregnant women. Half of the clinics in the study will be assigned to the OPTIMIZE intervention and half will administer standard care. |
MELISSA SIMON; | 2021-06-23 |
| 456 | A Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate The Safety and Treatment Efficacy of SAB-176 (a Quadrivalent Anti-seasonal Influenza Immunoglobulin Product) in An H1N1 Challenge Model in Healthy Adult Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Healthy adult participants will be challenged with the H1N1 Influenza virus and then treated with either SAB-176 or placebo. |
VICTORIA PARKER; | 2021-06-23 |
| 457 | Effect of SARS-CoV-2 Disease on Immune Responses, Disease Severity and Treatment Outcomes in Pulmonary Tuberculosis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the Coronavirus disease (COVID-19). Tuberculosis (TB) is the foremost cause of infectious deaths globally. In 2025, an additional 1.4 million TB deaths could occur as direct consequence of the COVID-19 pandemic. It is postulated that individuals with latent or active TB are more susceptible to SARS-CoV-2 disease and that COVID-19 disease rate is high in patients with active TB, … |
S. SUBASH BABU; | 2021-06-21 |
| 458 | Gender Differences in Stroke With COVID-19: Epigenetic and Biochemical Study of ACE2 Receptor and Relationship With Rehabilitative Outcome PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The new coronavirus SARS-CoV-2, causes the COVID-19 infection, which showed a form of neurovirulence involving the Central and peripheral Nervous Systems [Baig et al, 2020]. In a mouse model for human ACE2 expression, the virus entered the brain mainly through the olfactory bulb pathway [Netland et al, 2008], with an encephalic invasion uniformly lethal even with low viral doses and without lung involvement. The death of the animal was reasonably related to neuronal dysfunction/death in cardiorespiratory bone marrow centers, while the absence of ACE2 prevented severe encephalopathy. Men has a highly frequency of severe and lethal COVID-19, … |
IRENE GIOVANNA APRILE; | 2021-06-10 |
| 459 | Nigelle 5 Study Project/ Prevention of Influenza Syndroms PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group) |
RIADH BOUKEF; | 2021-06-05 |
| 460 | Pneumococcal Nasopharyngeal and Oropharyngeal Carriage in Adults Older Than 50 Years of Age in Outpatient Health Care Facility in Novi Sad PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is the first baseline pilot-study that will evaluate the NP and OP colonization with the underline of pneumococcal serotype distribution among adults older than 50 years of age in Serbia and Southeastern Europe. Results of this project will serve as additional evidence in order to increase coverage among adults and elderly |
VLADIMIR PETROVIC; | 2021-06-02 |
| 461 | Effectiveness of Quercetin In The Treatment of SARS-COV 2 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: In 1937, Albert Szent-Gyorgyi received a Nobel Prize for discovering vitamin C and flavonoids, as well as for exploring their biochemical properties. Originally, he gave the flavonoids the name vitamin P because of their effectiveness in reducing the permeability of blood vessels. This name was abandoned when it was realized that these substances were not really vitamins. Quercetin is extracted from a variety of plant sources, including the onion peel and the seeds and pods of Dimorphandra mollis, a legume tree native to South America. Although we are far from knowing everything about quercetin, its antioxidant, anti-inflammatory, … |
RIADH BOUKEF; | 2021-06-01 |
| 462 | Clinical Outcomes and Characteristics of Critically Ill Patients With Influenza and COVID-19 Induced ARDS: A Retrospective, Matched Cohort Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza. |
LEV VOLKOV; | 2021-06-01 |
| 463 | Diagnosis of Invasive Pulmonary Aspergillosis (IPA) – Specific Testing in Bronchial Secretions Versus Bronchoalveolar Fluid in Patients With and Without COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this research project is to compare the results of Aspergillus specific test methods Aspergillus Galactomannan Enzyme Immunoassay (GM-EIA), Aspergillus polymerase chain reaction (PCR), Aspergillus Galactomannan Lateral Flow Assay (LFA) from different respiratory tract secretions. The bronchoalveolar lavage (BAL) fluid and bronchial secretions (NBL) are compared in the same examination for each patient. |
MARIA SCHROEDER; | 2021-06-01 |
| 464 | Multilevel, Multidisciplinary, Faith-Based Participatory Interventions to Reduce COVID-19 Related-Risks Among Underserved African Americans PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: African American adults, specifically those managing chronic disease and social isolation, are one of the most vulnerable groups susceptible to COVID-19. This intervention involves a multi-disciplinary and culturally sensitive approach to address two major COVID-19 related challenges in this population. First, this program collaborates with predominantly African American churches to implement Federal and State guidelines aimed at preventing outbreaks of COVID-19 at faith-based gatherings. Second, this program trains church-based health advisors to help African American older parishioners manage their chronic health conditions and reduce psychological distress during the pandemic. |
MOHSEN BAZARGAN; | 2021-06-01 |
| 465 | Amantadine for COVID-19: A Randomized, Placebo Controlled, Double-blinded, Clinical Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Introduction: Corona virus disease 19 (COVID-19) is a devastating pandemic. By early February 2021, more than 102 million people were infected globally with more than 2.2 million reported deaths. Current treatments are approved for hospitalized patients with severe COVID-19 only. No treatment is approved to prevent progression to severe COVID-19 in the early stages of disease. Previous studies have indicated that amantadine is effective against severe acute respiratory syndrome corona virus 1 (SARS-CoV-1). Trials are needed to determine if this translates to a beneficial effect in patients with COVID-19. We hypothesize that preemptive therapy with amantadine of non-hospitalized high-risk adults with SARS-CoV-2 infection disease will prevent disease progression and hospitalization. Methods and analysis: The study is a randomized, double-blinded, placebo-controlled, single center study with two treatment arms; oral amantadine or placebo. Individuals with confirmed SARS-CoV-2 infection and one of following; i) age ≥ 40 years or ii) ≥ 18 years of age with at least one comorbidity or iii) ≥ 18 years of age with a body mass index (BMI) above 30 will be enrolled in the study. We plan to enroll 121 persons in each arm, with a total of 242 participants. Follow up period is 90 days. The primary outcome is disease severity on day 14 assessed by the 8-point COVID outcome scale proposed by the world health organization. Ethics and dissemination: Approvals by the Ethics Committee and National Competent Authorities will be obtained prior to study initiation. Results will be submitted for publication in a peer-reviewed journal and presented at international conferences. Impact: The results of the study will contribute with important knowledge on the efficacy and safety of oral amantadine in the treatment of non-hospitalized high-risk individuals with SARS-CoV-2 infection. |
NINA WEIS; | 2021-06-01 |
| 466 | Pilot Study of Convalescent COVID-19 Plasma Transfusion in Severe COVID-19 Patients at A Type A Teaching Hospital in Jamaica PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Corona virus Disease 2019 (COVID-19) can be a severe respiratory illness caused by Severe Acute Respiratory Syndrome (SARS-CoV2) for which there is no standard treatment in affected persons nor a vaccine to prevent the infection. The investigators propose to test whether the use of Convalescent plasma given to patients with severe COVID-19 disease will decrease risk of death, decrease use of ventilatory support decrease biomarkers of inflammation and improve measures of viral replication compared with controls subjects who were not transfused.Convalescent plasma, … |
GILIAN G WHARFE; | 2021-06-01 |
| 467 | Study for The Evaluation of The Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the usability of the system which includes the wearable device, app and cloud data processing, including an algorithm (Aura) capable of detecting possible early signs of respiratory infections in healthy individuals. In addition, the investigators would like to evaluate the presence of any allergic reactions to materials used in the manufacture of the EmbracePlus. |
EMPATICA | 2021-05-31 |
| 468 | Iron and Vaccine-preventable Viral Disease – An Experimental Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to viral vaccines, and whether iron treatment improves their response. |
NICOLE STOFFEL; | 2021-05-29 |
| 469 | Evaluation of Effects, Safety, Viral Load and Antibody Level of Functional Food Dietary Supplement Containing Grape Products in Controlled, Randomized Study Using SARSCoV-2 RT-PCR Positive Covid-19 Patients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to determine the safety and efficacy profile of the food supplement (KUNAMIN®) containing grape juice, seed, stem, and bark given to patients treated with the established treatment regimen against novel coronavirus infectious disease (COVID-19) via comparing Kunamin® group versus control group in a clinical trial. In this study, both the therapeutic effect and the safety of the Kunamin® product has been evaluated. The study has been conducted on COVID-19 infected patients. Within the scope of the study, … |
RAAS NUTRITIONALS | 2021-05-29 |
| 470 | The Role of The Bacillus Calmette-Guérin Vaccine (BCG) in The Clinical Evolution of COVID-19 and in The Efficacy of Anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) Vaccines PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Clinical trial with randomized allocation in two arms (BCG vaccine versus placebo) of volunteers at risk but not yet infected nor vaccinated against SARS-CoV-2. Initially will be evaluated whether BCG has a protective role against severe form of the disease. After participants are vaccinated against COVID-19, it will be evaluated whether BCG favors the vaccine’s efficacy. Volunteers will be recruited in three Brazilian states, with at least 250 seronegative in each group. The BCG-trained immunity stimulus will be investigated by assessing cytokines at D0 and D60 in a subsample of 50 participants per group. Until being vaccinated against COVID-19, … |
SIMONE LADEIA-ANDRADE; | 2021-05-27 |
| 471 | Effect of Kan-Jang® Supplementation in Patients Diagnosed With COVID-19: A Randomized, Quadruple-blind, Placebo-controlled Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The complexity of COVID-19 suggests a potential need for a range of therapies, including antiviral agents, immunostimulants, immunosuppressants, adaptogens, and anticoagulants. In this context, implementation of polyvalency drugs, which exhibit a wide range of biological activities and multitarget effects that is common for herbal medicines and specifically for Kan Jang, the fixed combination of Andrographis paniculata (Burm. F.) Wall. ex. Nees and Eleutherococcus senticosus (Rupr. & Maxim.) Maxim which are known to exhibit antiviral, immunomodulatory, … |
LEVAN RATIANI; | 2021-05-26 |
| 472 | Disease Registry for Pregnant Women With Suspected COVID-19 or Confirmed SARS-CoV-2 and Their Neonates PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The in-utero exposure of acute viral infection in some instances is proven to have short- and long-term neonatal effects during the postnatal and childhood period and the Zika virus, measles, mumps, and rubella are few examples. COVID-19 is caused by a novel coronavirus strain of unknown consequences. The main purpose of this registry is to collect baseline data and help to establish future studies and hypothesis generation. In addition, … |
SALWA ABO YAQOUB; | 2021-05-25 |
| 473 | The Treatment and Prevention of Covid-19 Infections Using Vitality Therapy or The Bible Cure Related Papers Related Patents Related Grants Related Experts View Highlight: The human immune system is enhanced by exposure to infrared radiation with the wavelength of 5 microns to 20 microns. Humans, at normal body temperature, radiate most strongly in the infrared at a wavelength of about 10 microns. Infrared energy sustains life and can be used to treat and prevent diseases, including Covid-19 infections. High temperature within the fever range obtained from infrared radiation causes the killer T-Cells to profilate. The Killer T-Cells improves ones immune system. The high temperature kills the Corona virus. In addition, multi-vitamins and minerals including high doses of Vitamin C, … |
KWASI DONYINA; | 2021-05-25 |
| 474 | VRC 325 (000410): A Phase I Open-Label Clinical Trial to Evaluate The Dose, Safety, Tolerability and Immunogenicity of Mosaic Quadrivalent Influenza Vaccine With and Without Adjuplex Compared With A Licensed Inactivated Seasonal QIV, In Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and sometimes the lungs. Vaccines are given to teach the body to prevent or fight infection. Researchers want to study a new vaccine to prevent the seasonal flu. Objective: To see if the FluMos-v1 vaccine is safe and how the body responds to it. Eligibility: Healthy adults ages 18-50 years inclusive were enrolled. Design: Participants were screened through a separate protocol. Participants were tested for COVID-19. They may have had a pregnancy test. Participants received the investigational FluMos-v1 vaccine or the licensed inactivated seasonal quadrivalent influenza vaccine Flucelvax injected in the upper arm. Participants completed a diary card for 7 days. They recorded any symptoms they had. They were given a thermometer to check their temperature. They were also given a ruler to measure any skin changes at the injection site. Participants had about 10 study visits. They were asked how they were feeling and if they had taken any medications. They had blood drawn. Some participants had an optional apheresis. Blood was removed through a needle in a vein in one arm. A machine separated the white blood cells. The rest of the blood was returned through a needle in a vein in the other arm. Participation lasted for 40 weeks. |
LESIA DROPULIC; | 2021-05-24 |
| 475 | Treatment of Respiratory Complications Associated With COVID-19, Influenza A, Metapneumovirus, Respiratory Syncytial Virus Infection Using Wharton’s Jelly-Umbilical Cord Mesenchymal Stromal Cells (ProTrans®): Open Phase IB Clinical Trial Related Papers Related Patents Related Grants Related Experts View Highlight: To investigate the safety and tolerance of a single infusion of ProTrans® in subjects with severe respiratory complications associated with pneumonia caused by COVID-19, Influenza A, Metapneumovirus or RSV infection. |
JOSEFINE SUNDH; | 2021-05-18 |
| 476 | A National, Multi-Center, Open-Label, Three-Arm, Phase II Study to Investigate The Effect of Montelukast Between Emergency Room Visits and Hospitalizations in COVID-19 Pneumonia in Comparison With Standard Treatment PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Small molecule inhibitors have previously been investigated in different studies as possible therapeutics in the treatment of SARS-CoV-2. In the current drug repurposing study, the investigators identified the leukotriene (D4) receptor antagonist Montelukast as a novel agent that simultaneously targets two important drug targets of SARS-CoV-2. The investigators initially demonstrated the dual inhibition (main protease and Spike/ACE2) profile of Montelukast through multiscale molecular modeling studies. Next, the investigators characterized its effect on both targets by different in vitro experiments including the Fluorescent Resonance Energy Transfer (FRET)-based main protease enzyme inhibition assay, surface plasmon resonance (SPR) spectroscopy, … |
SERDAR DURDAGI; | 2021-05-15 |
| 477 | Double-blind, Randomized Clinical Trial With Active Controls to Assess Safety, Immunogenicity and Lot-to-lot Consistency of Inactivated Split-virion Quadrivalent Influenza Vaccine of Butantan Institute PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: Studies have shown that a broader spectrum influenza vaccine may help in reducing the influenza burden of disease. Butantan Institute is currently developing a quadrivalent influenza vaccine candidate. This study is will provide safety and immunogenicity data on this quadrivalent influenza vaccine candidate. The study will be conducted in an open population of healthy participants (3 years old and above) recruited in different clinical sites in Brazil and will be adequately powered to assess safety, immune response (measured by GMT HI antibodies) to each viral strain in the vaccines and lot-to-lot consistency. |
BUTANTAN INSTITUTE | 2021-05-12 |
| 478 | Evaluation of Post-SARS-CoV-2 Vaccinal Response in Immunocompromised Patients PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to identify both the humoral immunological response through the detection of induced antibodies and the cellular immunological response through the detection of interferon gamma production by functional CD4+ and CD8+ cells in different groups of immunocompromised patients. For antibody detection, LIAISON® SARS-CoV-2 TrimericS assay (DiaSorin) will be used and for the evaluation of cellular immunity – QuantiFERON SARS-CoV-2 assay (QIAGEN). |
ELIZAVETA PADALKO; | 2021-05-10 |
| 479 | A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate The Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Wuhan) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4) PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Subjects will be recruited and divided into 3 groups: Experimental Group (468 subjects): 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects): 1st dose: PPV23 only, 2nd dose: IIV4 only. Blood samples will be collected 3 times: before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination. The immunogenicity and safety of both experimental and control groups will be analyzed. |
CHINA NATIONAL BIOTEC GROUP COMPANY | 2021-05-06 |
| 480 | Characterization of The Platelet and Immune Response in Adults Receiving SARS-CoV-2 Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: COVID-19 mRNA vaccines, administered with a two-dose regimen, have been shown to provide protection against Covid-19. However, the thromboinflammatory response toward these vaccines has never been explored as they exploit a completely new technology. It was reported that mRNA vaccines are highly reactogenic right after vaccine administration in particular in young adults, but we do not know which cells drive the early immune response to LNP-mRNA vaccines in humans and if platelets become activated as well. Moreover, it is not known if female, who have a heightened immune response to other vaccines, … |
ROBERTO CANGEMI; | 2021-05-05 |
| 481 | HERODOTUS: Head and Neck CancERs International COviD-19 CollabOraTion PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: To develop an International registry on head and neck cancer patients infected with COVID-19 |
AMANDA PSYRRI; | 2021-05-03 |
| 482 | Study of The Non-specific Effects of Influenza and MMR Vaccine on Infectious Diseases in Goiânia, Goiás, Brazil PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Various observational studies have reported an association between influenza vaccination and lower rates of infection with SARS-Cov-2 and less COVID-19 disease severity have been reported in large epidemiological studies in US, Brazil and Italy. Observational studies from the Netherlands showed also strongly reduced COVID-19 infection rates among influenza-vaccinated healthcare workers, with ORs of 0.61 and 0.49 for the first and second wave of COVID-19, respectively. In addition, in-vitro immunological analyses showed that the quadrivalent inactivated influenza vaccine can induce a trained immunity program against SARS-CoV-2 (2). In-vivo vaccination against influenza was also shown to induce improved interferon responses against SARS-CoV-2, … |
MIHAI NETEA; | 2021-05-01 |
| 483 | Hypertonic Saline Nasal Irrigation and Gargling (HSNIG) for Suspected COVID-19: Pragmatic, Web-based Bayesian Adaptive Randomised Controlled Trial in Pakistan PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Nasal washing (washout) followed by gargles with hypertonic saline (HSNIG) is believed to be effective in reducing the duration of illness in those with clinically suspected or confirmed COVID-19 being managed at home, and also is effective in reducing complications of COVID-19 and onward household transmission. This study plans to investigate whether the use of HSNIG performed by adults with symptoms consistent with COVID-19 reduces the duration of symptoms when compared to participants managed using standard care. |
OSMAN YUSUF; | 2021-05-01 |
| 484 | The Characteristic of Airway Microbiome Profiling of Chronic Obstructive Pulmonary Disease-bronchiectasis Overlap Patients and Its Association With Acute Exacerbation PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The overlap between chronic obstructive pulmonary disease (COPD) and bronchiectasis is a neglected area of research, and it is not covered by guidelines for clinical practice. COPD and bronchiectasis share common symptoms of cough with sputum production and susceptibility to recurrent exacerbations driven by new or persistent infection. Physiological criteria for the diagnosis of COPD and structural criteria for the diagnosis of bronchiectasis create the possibility for individual patients to fulfil both, … |
ZHENFENG HE; | 2021-05-01 |
| 485 | A Randomized Phase 2b Trial Evaluating Clinical Outcomes of Inhaled Sargramostim in High-risk Patients With Mild-moderate COVID-19 PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits to the emergency room or hospitalization, or death. |
PARTNER THERAPEUTICS | 2021-04-27 |
| 486 | Preliminary Examination of The Effects of Sodium Pyruvate Nasal Spray (N115) on Symptoms Associated With COVID19 Long Haulers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: There are approximately 12 million Americans with COVID-19 Long Hauler Symptoms, including athletes. The symptoms include hypoxemia (low SaO2), fatigue, coughing/sneezing, dyspnea, trouble breathing, body aches, headaches. This chronic disease is referred to as COVID-19 Long Haulers. 7-10% of COVID-19 long haulers are also at serious risk of developing Pulmonary Fibrosis. Conversely, patients with Pulmonary Fibrosis have an increased risk and susceptibility to COVID-19 infection, which can reach a mortality rate of 50%. In a Phase III Clinical Trial in patients in Pulmonary Fibrosis and Idiopathic pulmonary fibrosis, … |
CELLULAR SCIENCES | 2021-04-27 |
| 487 | SARS-COV2 Pandemic Serosurvey in A Rare Disease Population PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: The SARS-COV2 outbreak has had a major impact on the economy and society. Researchers want to learn how widespread the infection is in the rare disease community. To do this, … |
MATTHEW J MEMOLI; | 2021-04-19 |
| 488 | To Explore A Bridging Index for The Effectiveness of The Clinical Trial With Nasal Spray Lyophilized Live Attenuated Influenza Vaccine PF:3 Related Papers Related Patents Related Grants Related Experts View Abstract: With a randomized, blind, parallel placebo-controlled design, to screen the susceptible individuals aged 3~59 years old whose titers of either of Hi antibody level of H1N1, H3N2 … |
CHANGCHUN BCHT BIOTECHNOLOGY | 2021-04-16 |
| 489 | A Phase 2, Randomized, Observer-blind, Antigen and Adjuvant Dose Ranging Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59 Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years to determine the appropriate age population for this vaccine. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults. Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded. |
SEQIRUS | 2021-04-13 |
| 490 | Acute Respiratory Illness Surveillance (ARIS) By Monitoring Voice and Illness Symptom Changes Using A Mobile Application in A Low-Interventional Decentralized Study PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the AcRIS study is to obtain data to characterize the relationship between symptoms and voice features for (reverse transcription polymerase chain reaction (RT-PCR) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus, or Respiratory Syncytial Virus (RSV) positive participants with acute viral respiratory illness. This data will be used as the basis to build voice and symptom algorithm(s) for detection and monitoring of these illnesses. This would benefit vaccine development across several key disease areas, including SARS-CoV-2, … |
PFIZER | 2021-04-12 |
| 491 | Two Week Sub-chronic Double-blinded Placebo Controlled Trial Designed to Determine If Sodium Pyruvate Nasal Spray Will Reduce The Symptoms, Duration and Replication of COVID-19 Infection PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals demonstrated a reduction of inflammation in all lung and sinus diseases, in patients with COPD, Pulmonary fibrosis, CF, asthma, sinusitis , the flu and nasal inflammation and congestion. Inhaled sodium pyruvate reduces inflammation, congestion and in our phase III clinical study with Idiopathic Pulmonary Fibrosis patients we demonstrated statistically and clinical significant increase in FEV-1, SaO2, FVC, … |
CELLULAR SCIENCES | 2021-04-12 |
| 492 | Vaccines in A Time of Dual Pandemic: COVID-19 Vaccine in People with HIV PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective, non-randomized observational study to examine SARS-CoV-2 vaccine immunogenicity, immune activation and HIV reservoirs in people with HIV infection in comparison with HIV-negative individuals, in those aged 55 or more. As Canada is currently rolling out COVID-19 vaccines, the two most imminent vaccines are mRNA vaccines. These are the Pfizer-BioNTech COVID-19 vaccine given 3 weeks apart and the Moderna COVID-19 vaccine given 4 weeks apart. Given the unique storage requirements of these vaccines, it is expected that the Moderna vaccine will be used primarily in primary care clinics such as Maple Leaf Medical Clinic, Toronto. However, … |
MARIO OSTROWSKI; | 2021-04-10 |
| 493 | Follow-up Study for Patients Having Received FluBHPVE6E7 in Clinical Studies PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies. |
BLUESKY IMMUNOTHERAPIES | 2021-04-09 |
| 494 | Randomized Controlled Trial to Compare Clinical Efficacy of Surgical and Filtering Facepiece 2 Masks for Care Home Workers Treating COVID-19 Patients PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Recent results demonstrated an increased risk of COVID-19 infection among healthcare workers (HCW), particularly when access to personal protective equipment (PPE) was inadequate. (ref). During the COVID-19 pandemic, access to PPE has become complicated by a surge in worldwide demand combined with production limitations and logistical barriers. Since their introduction in hospitals in the 1990s, filtering facepiece (FFP) masks, mostly of the FFP2 type, are used by HCWs to protect themselves against bioaerosols due to tuberculosis, measles, … |
UNIVERSITY OF ZURICH | 2021-04-08 |
| 495 | An Effectiveness Trial (Phase IV) to Evaluate Protection of Children and Pregnant Women By Influenza Vaccine in Rural Bangladesh PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Annually influenza is a leading cause of severe disease and mortality particularly in young children <5 years old and pregnant women in the low and middle-income countries (LMICs) and both groups are prioritised for vaccination by the World Health Organisation (WHO). In Bangladesh, influenza is responsible for 10% of all childhood pneumonias and 9% of all death. Maternal influenza is associated with an increased risk of hospitalisation and foetal malformation. Influenza is a vaccine preventable disease, however, ... |
REBECCA COX; | 2021-04-07 |
| 496 | Apple Respiratory Study: A Prospective Study of Apple Watch-based Detection of Respiratory Viral Illness in Greater Seattle, WA PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The Apple Respiratory Study, a collaboration between researchers at Apple Inc. (the Study Sponsor or Sponsor) and the Seattle Flu Study team at the University of Washington (UW) (the UW Study Team), is a prospective, longitudinal cohort, low risk Study to collect certain data from Apple Watch and iPhone to determine whether such data can detect physiologic and non-physiologic changes in individuals associated with respiratory illnesses due to influenza, SARS-CoV-2 and other respiratory pathogens (the Study). |
HELEN CHU; | 2021-04-06 |
| 497 | Aged European Population QUality of Life in Infectious Diseases PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, … |
UNIVERSITY HOSPITAL GRENOBLE | 2021-04-01 |
| 498 | Description of Adherence to The Main Preventive Health Campaigns of Persons With Multiple Sclerosis PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Persons with multiple sclerosis (PwMS) might be more susceptible to infections and cancers and chronic diseases than general population, not because of the presence of the disease itself, but in relation to some specific therapies use or the degree of disability. Based on the currently available knowledge, the use of many disease-modifying drugs (DMDs) requires special attention to the possibility of infectious events or onset of cancer. In this perspective, … |
MONICA ULIVELLI; | 2021-04-01 |
| 499 | A Randomised, Multicentre Post-exposure Prophylaxis (PEP) Clinical Trial Evaluating RESP301, An Inhaled Therapy for Treatment of Lung Infections, for Prevention of Onward Transmission of Viral Infections Including SARS-CoV-2 to Household Members PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open label controlled household-randomised trial designed to evaluate the efficacy of RESP301 alongside standard of care (SOC) versus SOC alone. |
THIRTY RESPIRATORY | 2021-04-01 |
| 500 | An Open-Label, Multicenter, Parallel-Group, Randomized, Phase II/III Study to Evaluate The Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a national, multicenter, open-label, randomized, phase II/III trial that evaluates the efficacy and safety of favipiravir and ribavirin in the treatment of patients with confirmed COVID-19 observed within 72 hours. Approximately 100 patients will be randomized in 1:1 ratio and divided into two groups. |
ALPAY AZAP; | 2021-04-01 |