Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]; GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]; Fluarix [NH 2006/07 season]; Fluarix [NH 2007/08 season]
Intervention description: Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.; Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.; Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.; Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1596.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluarix; Influenza Infection; GSK Biologicals' influenza vaccine GSK576389A

Summary:

      This observer blind study is designed to compare the immune response of GSK Biologicals'
      influenza vaccine GSK576389A when administered using various presentations in adults aged 65
      years and older. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 65 years or 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.

        Exclusion Criteria:

          -  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.

          -  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 Visit 2 after vaccination.

          -  Planned administration of an influenza vaccine other than the study vaccines during
             the entire study period.

          -  Vaccination against influenza since January 2007 (including the Northern Hemisphere NH
             2006/2007 or NH 2007/08 influenza vaccine).

          -  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.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of hypersensivity to a previous dose of influenza vaccine.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine(s)

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, as determined by clinical evaluation 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.