Revaccination With Influenza Vaccine GSK1247446A
Condition: Influenza; Influenza, Human
MeSH terms: Influenza, Human
Intervention: Influenza Vaccine GSK1247446A; Fluarix™
Intervention description: Single dose, Intramuscular injection; Single dose, Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza vaccine

Summary:

      The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after
      revaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female aged 18-60 years old at the time of vaccination, who previously
             participated in 108656 clinical trial.

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  Written informed consent obtained from the subject.

          -  Free of obvious health problems 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 vaccination, have a negative pregnancy test and must
             agree to continue such precautions for two 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 within 30 days preceding the administration of the study vaccine, or
             planned use during the study period.

          -  Planned administration of an influenza vaccine other than the study vaccines during
             the entire study period

          -  Previous vaccination against influenza since January 2007.

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             three months prior to the first vaccine dose.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Administration of immunoglobulins and/or any blood products within three months
             preceding the dose of study vaccine or planned administration during the study period.

          -  History of hypersensitivity to a previous dose of influenza vaccine.

          -  History of confirmed influenza infection within the last 12 months.

          -  Pregnancy.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine(s)

          -  Acute disease at the time of enrolment.