Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult Population
Phase 2
Completed
- Conditions
- Influenza
- Registration Number
- NCT00377585
- Lead Sponsor
- GlaxoSmithKline
- 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 control group in younger adults aged 18 to 40 years was included.
- Detailed Description
This is a study to demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3350
Inclusion Criteria
- The subjects must be healthy adults 18-40 years or >/= 50 years.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To evaluate in all subjects, the safety, the humoral response and the cell-mediated immune (CMI) response of the adjuvanted influenza vaccine and Fluarix
Trial Locations
- Locations (1)
GSK Investigational Site
🇳🇴Skien, Norway