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Influenza, Human

Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults
NCT05874713 | PHASE 2 | INTERVENTIONAL

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, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection. The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as measured by hemagglutination inhibition (HI) assay on Day 1, Day 22, Day 29, Day 43, Day 202, Day 209 (H5N8 only), and Day 223.

Trial Information
9 Sites
480 Participants
Recruiting
18 Years to 35 Years

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Cullman Clinical Trials
Cullman,Alabama,United States,35055
Lifeline Primary Care
Lilburn,Georgia,United States,30047
Georgia Clinic
Norcross,Georgia,United States,30092
Velocity Clinical Research
Sioux City,Iowa,United States,51106
Velocity Clinical Research
Baton Rouge,Louisiana,United States,70809
Velocity Clinical Research
Grand Island,Nebraska,United States,68803
Velocity Clinical Research
Norfolk,Nebraska,United States,68701
Medical Care LLC
Elizabethton,Tennessee,United States,37643
Cope Family Medicine
Bountiful,Utah,United States,84010

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov