Study to Evaluate an Influenza Vaccine Candidate
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Vaccine GSK1247446A - 4 different formulations; Fluarix™
Intervention description: Single dose, Intramuscular injection; Single dose, Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1006.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza Vaccine

Summary:

      In order to find the formulation leading to a maximal increase of the immune response while
      maintaining an acceptable safety profile, this study is designed to evaluate the
      immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals'
      influenza vaccine administered in adults aged 18-64 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Only 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 - 64 years of age at the time of
             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 have a negative pregnancy test, practice adequate
             contraception for 30 days prior to vaccination, 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.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within three months prior to the first vaccine dose

          -  Administration of a vaccine not foreseen by the study protocol from 30 days before
             vaccination, up to 21 days after vaccination.

          -  History of hypersensitivity to a previous dose of influenza vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s)

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests.

          -  Confirmed influenza infection within a year preceding the study start.

          -  Administration of an influenza vaccine within a year preceding the study start.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Pregnant or lactating female.

          -  Concurrent participation 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

          -  Acute disease at the time of enrolment.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participating in the study.

          -  History of administration of experimental/licensed vaccine containing squalene and/or
             tocopherol within the last 12 months.