Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly Adults

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Fluarix

Biological: adjuvanted influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00386698

104887

Details and patient eligibility

About

Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.

Enrollment

200 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The subjects must be healthy adults ages 18-40 years or >/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine.

Exclusion criteria

Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination
Have a history of influenza infection since previous vaccination
Women who are pregnant
Subjects who have an acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination