Status:
COMPLETED
Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administratio...
Detailed Description
The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the candidate vaccine in healthy elderly persons. The candidate vaccine will be administered follo...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 61 years or above at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects or subjects with well controlled underlying disease.
Exclusion
- Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
- Administration of 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 the second vaccination with H5N1 vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of chronic alcohol consumption and/or drug abuse.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, 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 :
November 17 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2009
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT00397215
Start Date
November 17 2006
End Date
September 14 2009
Last Update
June 10 2019
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Dour, Belgium, 7370
2
GSK Investigational Site
Gozée, Belgium, 6534
3
GSK Investigational Site
Libramont, Belgium, 6800
4
GSK Investigational Site
Mont-Godinne, Belgium, 5530