Status:
COMPLETED
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
Eligibility Criteria
Inclusion
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hypersensitivity to a previous dose of influenza vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine.
Key Trial Info
Start Date :
July 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2009
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00714285
Start Date
July 14 2008
End Date
January 28 2009
Last Update
June 8 2018
Active Locations (1)
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1
GSK Investigational Site
Hradec Králové, Czechia, 500 03