Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Pandemic influenza vaccine GSK1562902A
Intervention description: IM administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 845.0
Sex: All
Minimum age: 19 Years
Maximum age: 61 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: immunogenicity; safety; GSK pandemic candidate vaccine

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 could be severe. Prevention and control will depend on the rapid production and
      worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must
      be developed and tested in clinical trials to determine the best formulation and vaccination
      schedule.

      The purpose of this study is to assess the immune response of a candidate pandemic vaccine.
      The protocol posting deals with objectives & outcome measures of the secondary phase of this
      study. The objectives and outcome measures of the primary phase are presented in a separate
      protocol posting (NCT number = 00449670).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.