Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human
Intervention: Pandemic influenza vaccine (GSK1119711A)-formulation 1; Pandemic influenza vaccine (GSK1119711A)-formulation 2
Intervention description: 2 or 3 doses, intramuscular injection, at different time points.; 2 or 3 doses, intramuscular injection, at different time points.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 512.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pandemic Flu; Pandemic influenza vaccine (GSK1119711A)

Summary:

      The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine
      administered at 2 different time points. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

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 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 be abstinent or have used adequate contraceptive
             precautions for 30 days prior to first vaccination, have a negative pregnancy test and
             must agree to continue such precautions for two months after completion of the
             vaccination series.

        Exclusion Criteria:

          -  Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4
             weeks (for live vaccines) prior to enrolment in this study.

          -  History of vaccination with investigational influenza pandemic vaccine.

          -  History of administration of an experimental/licensed vaccine

          -  Planned administration of a vaccine not foreseen by the study protocol during the
             following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6
             + 30 days; from Month 12 up to Month 12 + 30 days.

          -  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, based on
             medical history and physical examination

          -  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 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.