The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.
* Experimental design: multi-center, randomized (1:1), observer-blind, active-controlled study in 2 parallel groups with approximately: * Study vaccine: full dose of Fluarix by IM administration. * Control vaccine: full dose of Fluzone by IM administration. * Two scheduled visits per subject at days 0 (visit 1) and 21(visit 2) with blood sample collected at each visit to evaluate the immune response. There will be a final contact with each subject 6 months after vaccination for safety follow up and study conclusion. * Vaccination schedule: one IM injection at day 0. * Type of study: Self contained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,847
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Evansville, Indiana, United States
GSK Investigational Site
Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs)
Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs)
Immuno comparison of Fluarix vs Fluzone post-vacc in immunologically -competent, -compromised, overall, stratified by age
Safety comparison (sol local, general & unsol AEs, SAEs)
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Baltimore, Maryland, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Buffalo, New York, United States
GSK Investigational Site
Poughkeepsie, New York, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Carnegie, Pennsylvania, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
...and 5 more locations