Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A); Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Intervention description: Intramuscular administration, 1 dose; Intramuscular administration, 1 dose
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 720.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      The purpose of this study is to show the non-inferiority of different formulations of
      GlaxoSmithKline Biologicials' influenza vaccine.
    

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 65 years of age or older at the time of 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:

          -  Suspected (based on clinical symptoms) or confirmed (based on laboratory results)
             influenza infection within the last 6 months.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, 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.

          -  Previous vaccination against influenza with any seasonal vaccine since July 2007.

          -  Chronic administration 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.

          -  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) including egg and chicken protein.

          -  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 dose of study vaccine or planned administration during the study
             period.

          -  Any medical conditions in which IM injections are contraindicated