Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above
Phase 3
Completed
- Conditions
- Influenza
- Registration Number
- NCT00476307
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Healthy male or female aged 18 years or above;
- Non-childbearing or using adequate contraception;
- Written informed consent obtained from the subject.
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Exclusion Criteria
Subjects must not:
- Participate in a trial or using non-registered product;
- Use immunosuppressants, blood products, or another influenza vaccine during study;
- Have virologically confirmed influenza within 1 year;
- Have allergic or acute disease;
- Have unstabilized serious chronic disease;
- Be a lactating female.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Immune response 21 days post vaccination
- Secondary Outcome Measures
Name Time Method Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Freital, Sachsen, Germany