Status:
WITHDRAWN
A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
61+ years
Phase:
PHASE3
Brief Summary
This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
Eligibility Criteria
Inclusion
- Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).
- Female subjects of non-childbearing potential.
- Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).
- Written informed consent obtained from the subject.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion
- Previous 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™ .
- Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.
- Previous administration of a pandemic influenza vaccine.
- Administration of licensed vaccines within 4 weeks 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 study vaccination.
- 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 any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease and/or fever 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 study vaccination or during the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00866580
Start Date
May 1 2010
End Date
July 1 2011
Last Update
March 23 2015
Active Locations (1)
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1
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil, 80810-050