drugset / Trial / NCT00538473

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

NCT00538473

Phase 2 Completed 68 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelPrevention

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 study, the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.

Timeline

Start
2007-10-23
Primary completion
2007-12-01
Completion
2007-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK576389A Vaccine Intramuscular
Comparator Influenza Virus Vaccine Vaccine Intramuscular

Indications