Influenza (Pandemic) Clinical Trial
Official title:
A Phase I/II Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/13 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Matrix-M1™
This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years
old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by
prior influenza immunization within the past three months. Subjects 18 to 49 years of age
will comprise ~67% of subjects in each treatment group, and the balance will comprise
subjects 50 to 64 years.
Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0
and Day 21), in alternate deltoids. For each subject, study follow-up will span
approximately 385 days total, or approximately 13 months from the first dose.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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