Status:
COMPLETED
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.
Eligibility Criteria
Inclusion
- A male or female age between 18 and 64 years at the time of the first vaccination.
- non-childbearing female
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
7632 Patients enrolled
Trial Details
Trial ID
NCT00363870
Start Date
September 1 2006
End Date
June 1 2007
Last Update
March 23 2017
Active Locations (15)
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1
GSK Investigational Site
Hradec Králové, Czechia, 500 03
2
GSK Investigational Site
Espoo, Finland, 02100
3
GSK Investigational Site
Helsinki, Finland, 00100
4
GSK Investigational Site
Helsinki, Finland, 00930