Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix™; GSK Bio's Influenza Vaccine GSK576389A
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: 133.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine GSK576389A; Fluarix; 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 study,
      the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008
      season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in
      study 104887 are eligible for participation in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or
             GSK576389A investigational vaccines in the 104887 study (NCT00386698).

          -  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 between 19 and 42 years or 66 years and older at the time of the
             vaccination.

          -  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.

        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.

          -  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.

          -  History of confirmed influenza infection since the date of previous vaccination.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the administration of the study
             vaccine. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5
             mg/kg/day. Inhaled and topical steroids are allowed.)

          -  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. (Acute disease is defined as the presence of a
             moderate or severe illness with or without fever. All vaccines can be administered to
             persons with a minor illness such as diarrhea, mild upper respiratory infection with
             or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Oral
             temperature of <37.5°C).

          -  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.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.