Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' quadrivalent influenza vaccine; GSK Biologicals' trivalent influenza vaccine
Intervention description: Single intramuscular dose on Day 0.; Single intramuscular dose on Day 0.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary study; immunogenicity; safety

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza
      vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects who the investigator believes 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
             vaccination.

          -  Written informed consent obtained from the subject.

          -  If the subject is female, she must be of non-childbearing potential, 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 administration 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 3 months prior to administration of the vaccine.

          -  Administration of a vaccine not foreseen in the study protocol from 30 days before
             vaccination up to 21 days post vaccination.

          -  Confirmed influenza infection within a year preceding the study start.

          -  Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.

          -  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).

          -  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 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.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the administration of study vaccine or planned administration during the
             study period.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participating in the study.

          -  History of administration of experimental/licensed vaccine.