At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Fluvirin(TIVf) and Agriflu (TIV) for Influenza. Completed, enrolled 2,902 participants across 25 sites in 4 countries.
Detailed Summary
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.