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OpenTrials
Completed

NCT Number: NCT00386113

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

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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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

67 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluarix and adjuvanted influenza vaccine

Biological

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase II, Open, Controlled Study to Evaluate the Reactogenicity and the Immunogenicity of GlaxoSmithKline Biologicals' Adjuvanted Influenza Vaccine in Elderly Adults Previously Vaccinated With Either Fluarix™ or the Adjuvanted Vaccine.

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Oct 11, 2006
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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