Status:
COMPLETED
Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
- A male or female 60 years or older 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
- Acute 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 2 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00363077
Start Date
October 2 2006
End Date
November 17 2006
Last Update
June 8 2018
Active Locations (1)
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1
GSK Investigational Site
Ghent, Belgium, 9000