Influenza Clinical Trial
Official title:
A Phase II, Randomized, Open-Label Study to Evaluate the Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) in Healthy Adults
1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the
VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level
delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102
vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered
i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked
immunosorbent assay (ELISA) in a healthy adult population.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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