Influenza Clinical Trial
Official title:
A Phase II, Open-label, Escalating Dose-ranging Study to Evaluate the Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults ≥65 Years of Age
A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125 is safe and immunogenic at one or more of the doses tested.
A total of 80 community-living adults who are ≥65 years of age will be enrolled across the
four dose groups. Following vaccination, each subject will remain at the study site for at
least 30 minutes to be observed for any immediate reactogenicity complaints associated with
the Day 0 vaccination. Subjects will also be evaluated during clinic visits on Study Days 1,
7, 14, and 28 following vaccination. In addition, a safety follow-up telephone contact will
occur on post vaccination Day 3.
There will be 20 subjects per dose group. Up to 3 study sites will enroll 6-10 subjects per
dose group over a two-day enrollment period. Progression to the next higher dose group will
take place only if the Safety Monitoring Committee (SMC) assessment of the 30 (+15) minutes,
Day 0, and Day 1 post vaccination safety data; Day 3 telephone report: and the Day 0 and Day
1 serum C-reactive protein (CRP) results concludes that the lower dose was well tolerated.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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