At a glance
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Observer Blind Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals Influenza Vaccine GSK576389A Administered to Adults Over 65 Years Previously Vaccinated With the Same Vaccine, Compared to Fluarix™
In Brief
A Phase 3 clinical trial evaluating Fluarix and GSK Biologicals Influenza Vaccine GSK576389A for Influenza. Completed, enrolled 1,252 participants across 29 sites in 4 countries.
Detailed Summary
Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.
Study Details
Timeline
Interventions
Single dose, Intramuscular injection
Single dose, Intramuscular injection