Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix; GSK Biologicals Influenza Vaccine GSK576389A
Intervention description: Single dose, Intramuscular injection; Single dose, Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluarix; GSK Bio's influenza vaccine GSK576389A; Influenza infection

Summary:

      Since influenza vaccines are administered every year because of the frequent change in their
      antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza
      vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this
      observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will
      receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only
      subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for
      participation in this study.
    

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.

          -  Written informed consent obtained from the subject.

          -  Free of an acute aggravation of the health status as established by clinical
             evaluation 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.

          -  Male or female subjects who participated in the 104888 study (NCT00377585) and were
             enrolled in the >= 65 years age group or in the 18-40 years age group .

        Exclusion Criteria:

          -  Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to enrolment in this study.

          -  Planned administration of a vaccine not foreseen by the study protocol up to 30 days
             after vaccination

          -  Planned administration of an influenza vaccine other than the study vaccines during
             the entire study period

          -  Any vaccination against influenza since January 2007

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of hypersensitivity to a previous dose of influenza vaccine

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine(s)

          -  Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or pre-existing
             laboratory screening tests

          -  Acute disease at the time of enrolment

          -  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

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days prior to vaccination, or planned use during the study
             period

          -  Any medical conditions in which IM injections are contraindicated

          -  Pregnant or lactating female, or planning to become pregnant or to discontinue
             contraceptive precautions.