Evaluate Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' influenza vaccine GSK576389A; 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: 68.0
Sex: All
Minimum age: 67 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Bio's influenza vaccine GSK576389A; Influenza Infection; Fluarix

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 study,
      the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008
      season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in
      study 107973 (NCT00386113) are eligible for participation in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or
             GSK576389A vaccines in the 107973 study (NCT00386113).

          -  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 aged >= 67 years at the time of re-vaccination.

          -  Written informed consent obtained from the subject.

          -  Free of an acute aggravation of the health status as established by clinical
             evaluation (medical history and medical history directed examination) before entering
             into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days prior to vaccination, or planned use during the study
             period.

          -  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 21 days
             after vaccination.

          -  Confirmed influenza infection since the date of previous vaccination.

          -  Planned administration of an influenza vaccine other than the study vaccines during
             the entire study period.

          -  Vaccination against influenza since January 2007 with the Northern Hemisphere
             2007/2008 influenza vaccine or 2006/2007 influenza vaccine.

          -  Administration of more than 14 days of immunosuppressants or other immune-modifying
             drugs within six months prior to the administration of the study vaccine.

          -  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 clinical evaluation (medical history and
             medical history directed 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 administration of the study vaccine or planned administration
             during the study.

          -  Any medical conditions in which intramuscular injections are contraindicated.