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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Fluarix and adjuvanted influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00386113

107973

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 profile of adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects previously vaccinated with Fluarix or the influenza adjuvanted vaccine, will receive a booster dose with the 2006-2007 season's formulations of either Fluarix or the adjuvanted vaccine.

Enrollment

74 patients

Sex

All

Ages

67+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The subjects must be healthy elderly >/= 67 years and previously vaccinated with Fluarix or the adjuvanted vaccine.

Exclusion criteria

Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immunemodifying 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, or if subjects have acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination