Pandemic Influenza Clinical Trial
Official title:
A Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Administered With and Without an Adjuvant Patch in Healthy Adults
This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A
maximum of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in
this study. Subjects will receive an intramuscular injection of either the influenza A/H5N1
(low, medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This
study will be performed in two parts.
In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A
Safety Review Committee (SRC)will review all safety data, including laboratory values,
through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments
are considered safe, Part 2 of the study will be initiated and a second vaccination will be
administered to subjects in Part 1 on Day 21.
In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same
visit structure and protocol-defined requirements as subjects in Part 1, without the
additional laboratory safety measurements. An SRC review will also be performed of all
safety data through the Day 28 visit for subjects participating in Part 1.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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