Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not); Fluarix
Intervention description: intramuscular injection; Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 437.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H5N1; influenza; vaccine

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-administration schedule (21 days apart) in adults over 60 years of age. The persistence
      of influenza antibodies will also be evaluated 24 months after vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.