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NCT00377585 Clinical Trial

Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult Population

Influenza Clinical Trial

Official title:
A Phase II/III, Observer-blind, Multi-Country, Multi-Centre, Randomized Study to Demonstrate the Superiority in Terms of Immunogenicity of Adjuvanted Influenza Vaccine Administered in Adults Aged 50 Years and Older Compared to Fluarix™

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00377585
Other study ID # 104888
Secondary ID
Status Completed
Phase Phase 2
First received September 14, 2006
Last updated April 20, 2017
Start date September 22, 2006
Est. completion date January 30, 2007

Study information
Verified date April 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is designed to demonstrate a meaningful difference in immunogenicity between the candidate adjuvanted vaccine compared to the licensed Fluarix vaccine in subjects aged 50 years and above.

A control group in younger adults aged 18 to 40 years was included.

Description:

This is a study to demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population.

Recruitment information / eligibility
Status Completed
Enrollment 3350
Est. completion date January 30, 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- The subjects must be healthy adults 18-40 years or >/= 50 years.

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, or a licensed vaccine within 2 (inactivated) to 4 (live) weeks before vaccination, if women are pregnant or lactating, or if subjects have acute clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Fluarix

• adjuvanted influenza vaccine

Locations
Country Name City State
Belgium GSK Investigational Site Gent
Germany GSK Investigational Site Augsburg Bayern
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Haag Bayern
Germany GSK Investigational Site Hoehenkirchen-Siegertsbrunn Bayern
Germany GSK Investigational Site Langquaid Bayern
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Messkirch Baden-Wuerttemberg
Germany GSK Investigational Site Ruedersdorf Brandenburg
Norway GSK Investigational Site Bekkestua
Norway GSK Investigational Site Elverum
Norway GSK Investigational Site Fredrikstad
Norway GSK Investigational Site Hamar
Norway GSK Investigational Site Haugesund
Norway GSK Investigational Site Paradis
Norway GSK Investigational Site Skien
United States GSK Investigational Site Carnegie Pennsylvania
United States GSK Investigational Site Chaska Minnesota
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Clearwater Florida
United States GSK Investigational Site Coral Gables Florida
United States GSK Investigational Site Erie Pennsylvania
United States GSK Investigational Site Milford Massachusetts
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Poughkeepsie New York
United States GSK Investigational Site Somers Point New Jersey

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary To demonstrate that the immune response induced by the adjuvanted influenza vaccine in the elderly is superior to that induced by Fluarix, for each vaccine strain
Secondary To evaluate in all subjects, the safety, the humoral response and the cell-mediated immune (CMI) response of the adjuvanted influenza vaccine and Fluarix
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