Influenza Clinical Trial
Official title:
A Multi-Center, Phase IV, Randomized, Controlled, Observer Blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Trivalent Subunit Inactivated Influenza Vaccine in Healthy Subjects Aged 50 Years and Above
Demonstrate non-inferiority of the post-vaccination (Day 22) Hemagglutination inhibition
(HI) Geometric Mean Titers (GMTs) of trivalent, inactivated, subunit influenza vaccine (TIV)
over the corresponding GMTs of the comparator vaccine for all three strains, in healthy
adults aged 50 years and above.
Demonstrate non-inferiority of the percentages of subjects achieving seroconversion in
antibody titers at Day 22 in the TIV group over the corresponding percentages of subjects in
the comparator group for all three strains, in healthy adults aged 50 years and above.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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