Status:
COMPLETED
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
Eligibility Criteria
Inclusion
- A male or female aged 18-59 years at the time of the first vaccination.
- Free of obvious health problems
Exclusion
- Use of non-registered products
- Administration of immune-modifying drugs.
- Administration of vaccine 30 days before enrolment in study.
- Immunosuppressive or immunodeficient condition.
- Hypersensitivity to a previous dose of influenza vaccine
- Previous vaccination against influenza in 2006
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- History of confirmed influenza infection within the last 12 Months.
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine
Key Trial Info
Start Date :
October 3 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00374842
Start Date
October 3 2006
End Date
November 30 2006
Last Update
June 8 2018
Active Locations (1)
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1
GSK Investigational Site
Wilrijk, Belgium, 2610