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

Completed · Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00377585

Run by

GlaxoSmithKline

People needed

3350

Starts

2006-09-22

Expected to finish

2007-01-30

Last updated by the study team

2017-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Coral Gables, Florida, United States
• GSK Investigational Site — Milford, Massachusetts, United States
• GSK Investigational Site — Chaska, Minnesota, United States
• GSK Investigational Site — Somers Point, New Jersey, United States
• GSK Investigational Site — Poughkeepsie, New York, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Carnegie, Pennsylvania, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Ghent, Belgium
• GSK Investigational Site — Messkirch, Baden-Wurttemberg, Germany
• GSK Investigational Site — Augsburg, Bavaria, Germany
• GSK Investigational Site — Haag, Bavaria, Germany
• GSK Investigational Site — Höhenkirchen-Siegertsbrunn, Bavaria, Germany
• GSK Investigational Site — Langquaid, Bavaria, Germany
• GSK Investigational Site — Rüdersdorf, Brandenburg, Germany
• GSK Investigational Site — Leipzig, Saxony, 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 — Bekkestua, Norway
• GSK Investigational Site — Elverum, Norway

Full record on ClinicalTrials.gov

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