drugset / Trial / NCT00529516

Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

NCT00529516

Phase 3 Completed 1252 enrolled GlaxoSmithKline
Non-randomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2007-10-15
Primary completion
2007-12-21
Completion
2008-06-04

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK576389A Vaccine Intramuscular
Comparator Influenza Virus Vaccine Vaccine Intramuscular

Indications