Flu Clinical Trial
Official title:
Phase 1 Clinical Study To Investigate The Safety And Immunogenicity Of The H3N2 (A/Brisbane/10/2007) M2SR Monovalent Influenza Vaccine
The purpose is of this study is to assess the safety and tolerability of three dose levels of H3N2 M2SR influenza vaccine versus placebo delivered intranasally to healthy adult subjects.
Healthy adult subjects will be screened with the objective to randomize 96 subjects with the
lowest levels of H3 hemagglutination inhibition (HAI) titers that meet all
inclusion/exclusion criteria and have signed an informed consent. Subjects will be rank
ordered from low to high based on their HAI titer. Subjects will then be assigned treatment
based on a randomization to either active vaccine or placebo. The first two subjects dosed in
each dose cohort will serve as sentinels and will receive active IP (not randomized).
Subjects will receive a single dose inoculation of the H3N2 M2SR seasonal monovalent
influenza vaccine administered intranasally as a liquid formulation, or placebo (saline). The
sentinel subjects will be vaccinated in dose cohort 1 and a safety monitoring committee (SMC)
will conduct a review of safety data, tolerability, reactogenicity, and clearance of
infectious virus prior to dosing the remaining subjects of the cohort with active or placebo.
After the last subject in the cohort has been followed for at least 7 days the SMC will
conduct another review of safety data prior to proceeding to the next higher dose level:
Cohort 2. The same processes of sentinel subject dosing and SMC review will be conducted for
Cohorts 2 and 3.
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