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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Universal M2e influenza vaccine
Jean Brown Research
Salt Lake City, Utah, United States
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Solicited local and general symptoms experienced within 7 days after vaccination 1.
Time frame: 0 to 7 days after vaccination
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Solicited local and general symptoms experienced within 14 days after vaccination 2
Time frame: 14 days after vaccination
Anti-M2e Serum Antibody Concentration
Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.
Time frame: 42 days (+/- 2)
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