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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-16

Study Completion Date

2006-11-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Fluarix and adjuvanted influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes