A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults
Phase 4
Completed
- Conditions
- Influenza
- Registration Number
- NCT00363870
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7632
Inclusion Criteria
- A male or female age between 18 and 64 years at the time of the first vaccination.
- non-childbearing female
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Exclusion Criteria
- Use of non-registered products
- Pregnancy
- Hypersensitivity to a previous dose of influenza vaccine
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine
- Administration of any other influenza vaccine for the season 2006-2007
- Chronic disorders of the pulmonary or cardiovascular system, including asthma.
- Administration of immune-modifying drugs
- Administration of immunoglobulins and/or any blood products
- History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method occurrence of confirmed influenza
- Secondary Outcome Measures
Name Time Method Occurrence of pneumonia Safety during 7 Months occurrence of influenza like illness Immune response at days 0 and 21
Trial Locations
- Locations (1)
GSK Investigational Site
🇫🇮Vantaa, Finland