Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Bio's influenza vaccine GSK2186877A; Fluarix
Intervention description: Intramuscular (IM) administration, 1 dose; Intramuscular (IM) administration, 1 dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 526.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Elderly

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline
      Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      1. The objectives & outcome measures of the primary phase are presented in a separate
      protocol posting (NCT number = 00540592).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who
             participated in the 110847 study and completed the 6 month follow-up.

          -  Written informed consent obtained from the subject.

          -  Fee of acute aggravation of the health status as established by clinical evaluation
             (medical history and medical history directed examination) before entering into the
             study.

          -  Female subjects must be of non-childbearing potential.

        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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in
             the study protocol during the entire study period.

          -  Vaccination against influenza since January 2008 with a seasonal 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.

          -  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 (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 IM injections are contraindicated.

          -  Lactating female, female planning to become pregnant or planning to discontinue
             contraceptive precautions.