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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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