Status:
COMPLETED
Study to Demonstrate the Lot-to-lot Consistency and to Evaluate 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 phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ adminis...
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion
- A male or female age 60 years or older at the time of the vaccination.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment
Key Trial Info
Start Date :
April 27 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2006
Estimated Enrollment :
3124 Patients enrolled
Trial Details
Trial ID
NCT00321763
Start Date
April 27 2006
End Date
July 7 2006
Last Update
June 8 2018
Active Locations (46)
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1
GSK Investigational Site
Tartu, Estonia, 50417
2
GSK Investigational Site
Caen, France, 14052
3
GSK Investigational Site
Gières, France, 38610
4
GSK Investigational Site
Lagord, France, 17140