Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Influenza

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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...

Detailed Description

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

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

September 22 2006

Trial Type :

INTERVENTIONAL

End Date :

January 30 2007

Estimated Enrollment :

3350 Patients enrolled

Trial Details

Trial ID

NCT00377585

Start Date

September 22 2006

End Date

January 30 2007

Last Update

April 24 2017

Active Locations (30)

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Page 1 of 8 (30 locations)

1

GSK Investigational Site

Clearwater, Florida, United States, 33761

2

GSK Investigational Site

Coral Gables, Florida, United States, 33134

3

GSK Investigational Site

Milford, Massachusetts, United States, 01757

4

GSK Investigational Site

Chaska, Minnesota, United States, 55318

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