Avian Influenza Clinical Trial
Official title:
A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/2013 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Adjuvant 1
This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old.
Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior
influenza immunization within the past three months. Proportions of subjects in the various
strata will not be pre-specified; rather, the goal will be to achieve an approximately equal
distribution of subjects with these characteristics across the various treatment groups.
Treatments will comprise two identical IM doses 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 Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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