Status:
COMPLETED
Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
19-61 years
Phase:
PHASE3
Brief Summary
Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and ...
Eligibility Criteria
Inclusion
- Subjects who completed participation in primary phase of this study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or be post-menopausal; if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Exclusion
- Administration of any licensed vaccines within 4 weeks prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol: 4 weeks prior to any visit or within 30 days after vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first visit or planned use during the study
- Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required).
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of chronic alcohol consumption and/or drug abuse.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first visit or planned use during the study.
- Pregnant or lactating women.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first visit, or planned use during the study period.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Key Trial Info
Start Date :
March 23 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2011
Estimated Enrollment :
845 Patients enrolled
Trial Details
Trial ID
NCT00652743
Start Date
March 23 2008
End Date
June 8 2011
Last Update
August 2 2018
Active Locations (6)
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1
GSK Investigational Site
Hong Kong, Hong Kong
2
GSK Investigational Site
Singapore, Singapore, 308433
3
GSK Investigational Site
Singapore, Singapore, 529889
4
GSK Investigational Site
Taipei, Taiwan, 100