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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine, during 21 days following administration of the vaccine.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the humoral immune response & cell-mediated immune response 21 days after revaccination with candidate vaccine.

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial