Clinical Research Directory

Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS

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.

Conversational AI for Adult Flu Vaccination Decisions

This randomized trial tests whether an online guide combining short evidence cards with an AI-guided conversation increases flu-vaccination intention among US adults who haven't decided whether to get a flu vaccine this season. Participants recruited through Prolific are randomly assigned to the flu guide or to a structure-matched guide about everyday accident safety. The primary outcome is self-rated likelihood of getting a flu vaccine this season (1-7), asked immediately after the session. Participants are asked at about 2 and 8 weeks whether they have been vaccinated. The study is powered for the intention outcome but not for vaccination. For vaccination, it estimates the effect, the base rate, and follow-up response, to size a later, larger trial.

Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza

The goal of this Phase II/III study is to investigate the safty and efficacy of 102D-6 in adolescents and adults with influenza. The main aim to answer: 1. Phase II study is to evaluate the efficacy of 102D-6 in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. The results will be used to design the Phase III study. 2. Phase III study is to evaluate the efficacy of 102D-6 by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza. Participants will be taken 102D-6/Placebo once, and be observed by 15 days.

A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants

The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).

Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)

The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk. Patients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).

A Study to Evaluate the Immune Response and Safety of a Vaccine Against Influenza in Adults 18-64 Years of Age

This clinical trial will study an investigational seasonal influenza vaccine in adults 18 to 64 years of age. The vaccine is based on messenger ribonucleic acid, also called mRNA. The main goals of the study are to learn how well the vaccine helps the body make an immune response against influenza and what medical problems participants may have after vaccination. Researchers will also compare immune responses in adults 18 to 64 years of age from this study, with immune responses in adults 65 years of age and older from another study. Participants will receive 1 injection into the upper arm muscle and will be followed for about 6 months.

Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults

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, and Day 43 serology data. The primary safety analysis is based on solicited local and systemic adverse events (AEs) reported within 10 days after each vaccination, unsolicited AEs reported within 3 weeks after each vaccination, and serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal from the study, and AEs of special interest (AESIs) reported throughout the study.

A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above

The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults.

A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age

This study will compare an investigational mRNA flu vaccine with a licensed flu vaccine in adults 65 years of age and older. Participants will receive one injection and will be followed during the flu season. The study will measure prevention of laboratory-confirmed flu illness, side effects, and immune responses.

Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults

The goal of this clinical trial is to evaluate the safety and immune responses of three different dose levels a self-amplifying RNA pandemic influenza vaccine (ARCT-2304) in adults. The key objectives of the study are: * To evaluate safety and reactogenicity of different dose levels of the ARCT-2304 vaccine * To describe the Immune responses of different dose levels of the ARCT-2304 vaccine as measured by hemagglutination inhibition (HAI) and neuraminidase enzyme-linked lectin (ELLA) antibody responses Researchers will compare the results with licensed influenza vaccines to select the most optimal dose level and schedule for vaccine administration in terms of safety and immunogenicity for further development of the vaccine. Participants will receive 2 doses of the ARCT-2304 vaccine or 1 dose of licensed influenza vaccine and 1 dose of placebo. They will be asked: * to complete a daily diary for 7 days after each vaccination, answering questions how they have been feeling on that day. * to provide blood samples at each visit in the clinic * to comply with all study visits and procedures (e.g., be available for planned telephone contacts and unscheduled clinic visits, if required)

A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age

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.

Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years

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.

An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection

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, there are no licensed influenza vaccines for children aged less than six months old. As a requirement of the Pediatric Investigation Plan European Union (EU), GlaxoSmithKline (GSK) will be conducting this open-label, multi-center, single arm, post-marketing authorization study to evaluate the PK and collect safety and tolerability information of IV zanamivir in hospitalized neonates and infants under 6 months of age with confirmed complicated influenza infection. The total duration of study participation for each participant will be up to 24 days with a study treatment period up to 10 days and 14 days of post-treatment follow up. However, for a given participant, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests as assessed by the investigator warrant further treatment. DECTOVA is a trademark of GlaxoSmithKline group of companies.

Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age

This Phase 2, randomized, observer-blind, dose-confirmation clinical study evaluated different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects were randomized into 1 of 4 possible treatment groups with approximately 250 participants per group. Every participant received an influenza vaccine injection on Day 1 and were to be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.

Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites

A Study About Modified RNA Vaccines Against Influenza in Healthy Adults

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, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid. Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat. The study is seeking for participants who: * are at least 18 years of age * have not received an influenza vaccine within the last 6 months * are generally healthy This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC). All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm: * 1 of the modRNA influenza vaccines that is being studied; or * an approved influenza vaccine approved for use in their respective age group. Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.

Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)

The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm in participants with acute respiratory infection caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV) in need for oxygen therapy. The main questions it aims to answer are: * Are both doses of PRS CK STORM (dose A and dose B) safe as an intravenous drug to modulate inflammatory processes, such as the cytokine storm in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV? * Are both doses of PRS CK STORM (dose A and dose B) effective as an intravenous drug to modulate SIRS-associated cytokine storm caused by SARS-Cov-2, influenza A, influenza B and RSV compared to the control group? * What are the anti-inflammatory and pro-inflammatory cytokine profiles after treatment with two different doses of PRS CK STORM in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV? Researchers will compare both doses of PRS CK STORM with the control group to test whether the anti-inflammatory action of PRS CK STORM is safe and effective in modulating the cytokine storm for the treatment of SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV. In addition, the anti-inflammatory and pro-inflammatory cytokine profiles after treatment PRS CK STORM compared to placebo group in these participants will be also studied.

A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older

"The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults."

Immunogenicity of Alternative Annual Influenza Vaccination Strategies in Older Adults in Hong Kong

This study allows to evaluate the strength and duration of immune responses between annual receipt of standard inactivated vaccine and alternative potent vaccines, including annual receipt of adjuvanted inactivated vaccine, annual receipt of high-dose inactivated vaccine, annual receipt of recombinant HA vaccine, and the alternate combinations of the former three vaccines over four years, for identifying improved vaccination strategies for influenza vaccination in older adults in a location experiencing a subtropical pattern in influenza activity.

Dynamics of the Immune Responses to Repeat Influenza Vaccination Exposures

The aims of this vaccine trial are: (1) to measure humoral and selected cellular immune responses to repeated influenza vaccination with Flublok, including these responses' associations with age, birth year, and prior vaccination history; (2) to identify the characteristics of study participants who are vaccinated but still become infected with influenza virus ("vaccine failures") and participants who have poor immune responses to vaccination; and (3) to predict how influenza vaccinations and infections shape immunity.

A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed

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, who received 2 doses of aH5N1c in the parent study V89\_18 are randomized in a 1:1 ratio to receive either two aH5N6c vaccinations, 3 weeks apart (group 1) or an aH5N6c vaccination on Day 1 and saline placebo on Day 22 (group 2). Eligible subjects, who received placebo in the parent study will receive two aH5N6c vaccinations, 3 weeks apart (group 3). After the second vaccine administration, subjects are monitored for approximately 6 months for safety and antibody persistence. The total study duration will be approximately 7 months per subject.

Clinical Trials of Quadrivalent Influenza Vaccine

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.

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

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

Vaccine Pandemic Preparedness Through Airway Immunology Characterization

The study aims to compare the effectiveness of live attenuated influenza vaccines (LAIV) and intramuscular-inactivated vaccines (IIV) in healthy individuals aged 18-49. It will investigate cellular and humoral responses, identify immunological markers for targeted vaccine improvement, and establish a collaborative platform for accelerated immunological and clinical vaccine research.