Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human
Intervention: H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain); H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain); H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)
Intervention description: Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.; Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.; Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1206.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza Vaccine

Summary:

      The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a
      GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults
      aged between 18 and 60 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol

          -  A male or female between, and including, 18 and 60 years of age at the time of the
             first vaccination.

          -  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, 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 Criteria:

          -  Administration of any 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 during the
             following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4
             weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or
             Month 6 + 51 days for the control groups).

          -  Previous vaccination with a pandemic candidate vaccine or a vaccine containing the
             same adjuvant as the study vaccine.

          -  Previous proven contact with H5N1 wild type virus (i.e. contact with an individual
             with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry)
             which died as a result of H5N1 infection).

          -  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
             candidate vaccines.

          -  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 3 months
             preceding the first administration of the candidate vaccine or during the study.

          -  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 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.