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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00386113

Influenza

COMPLETED PHASE2

Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population

NCT00318058

Influenza

COMPLETED PHASE1

Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

NCT00363077

Influenza

COMPLETED PHASE2

Evaluate Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

NCT00538473

Influenza

COMPLETED PHASE2

Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

NCT00538213

Influenza

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluarix

Intervention Type BIOLOGICAL

adjuvanted influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.