Influenza Clinical Trial
Official title:
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™
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.
This study involves 2 age groups (based on primary study):
Subjects enrolled in the >= 65 yrs age group in the primary study. Subjects enrolled in the
18-40 yrs age group in the primary study. The study will be conducted in an open manner for
this age group.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
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