Status:
COMPLETED
Study to Evaluate an 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 immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 yea...
Detailed Description
Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. The immune response will be evaluated at days 0, 21 and 180 after vaccination. The s...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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 criteria:
- 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 hypersensivity to a previous dose of influenza vaccine.
- Previous vaccination against influenza within the 9 months prior to enrollment.
- 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.
Exclusion
Key Trial Info
Start Date :
May 11 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2006
Estimated Enrollment :
1220 Patients enrolled
Trial Details
Trial ID
NCT00321373
Start Date
May 11 2006
End Date
July 18 2006
Last Update
June 8 2018
Active Locations (17)
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1
GSK Investigational Site
Helsinki, Finland, 00100
2
GSK Investigational Site
Helsinki, Finland, 00930
3
GSK Investigational Site
Jarvenpaa, Finland, 04400
4
GSK Investigational Site
Kotka, Finland, 48100