Influenza Clinical Trial
Official title:
A Phase II, Multicenter, Randomized, Double-Blind, Active Comparator Controlled Study of the Immunogenicity and Safety of VAX2012Q, A Quadrivalent Influenza Vaccine in Healthy Adults 18-64 Years
This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at a 1:1:1 ratio.
This is a multi-center, randomized, double-blind, active comparator controlled study in
which up to 450 healthy adults age 18-64 years will be administered either VAX2012Q or
Fluzone. Four hundred fifty (450) subjects will be randomized 1:1:1 ratio of either 8 or 12
mcg VAX2012Q dose levels or to Fluzone® Quadrivalent vaccine.
Randomization will be stratified for age (18-49 and 50-64 years). Subjects will be
stratified by two age groups (18-49 and 50-64) and randomized in a 1:1:1 ratio to either 8
or 12 mcg VAX2012Q dose levels or to Fluzone® Quadrivalent vaccine. 25-35% of the total
study population will be recruited into the 50-64 age group.
The primary objective of the study is to evaluate the seroconversion rates at Day 21 for
both dose levels of VAX2012Q.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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