Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose; Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Intervention description: A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.; Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 350.0
Sex: All
Minimum age: 19 Years
Maximum age: 61 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The present study is designed to evaluate the reactogenicity and immunogenicity of one or two
      booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults
      aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate
      vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634)
      will be recruited. This protocol posting deals with objectives & outcome measures of the
      booster phase. The objectives & outcome measures of the primary phase are presented in a
      separate protocol posting (NCT00309634)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol should be enrolled in the study.

          -  For previously primed subjects: participation in the primary study (NCT00309634).

          -  For unprimed subjects: male or female between and including, 19 and 61 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 she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test and continue such precautions for 2 months
             after completion of the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  For unprimed subjects who did not participate in the primary study (NCT00309634):
             Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Planned administration/ administration of a licenced vaccine not foreseen by the study
             protocol within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) of
             the first dose of vaccine(s).

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device).

          -  Applicable for control group only: previous vaccination with a pandemic candidate
             vaccine or a vaccine containing the investigational vaccine adjuvant.

          -  History of hypersensitivity to vaccines.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s).

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Acute or chronic, 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.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participation in the study.

          -  Lactating female.

          -  History of chronic alcohol consumption and/or drug abuse