Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK investigational vaccine 2186877A; FluarixTM
Intervention description: Single dose, intramuscular injection; Single dose, intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 370.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza Vaccines; GSK Bio's influenza vaccine GSK2186877A; influenza infection

Summary:

      The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine.
      Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the
      same vaccine for the third time. For this study the masking is "observer-blind" for elderly
      subjects and "open" for young adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study. Specific attention
             should be given to the compliance potential of subjects with suspected drug or alcohol
             abuse.

          -  A male or female aged 19-43 years or >=66 years at the time of the vaccination and who
             participated in the study NCT00760617 and completed the 6-month follow-up.

          -  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.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,
             hysterectomy, ovariectomy or post-menopause.

          -  Female subjects of childbearing potential may be enrolled in the study if the subject:

          -  has practiced adequate contraception for 30 days prior to vaccination, and

          -  has a negative pregnancy test on the day of vaccination, and

          -  has agreed to continue adequate contraception for 2 months after the vaccination.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If ANY exclusion
        criterion applies, the subject must not be included in the study:

          -  Use of any investigational or non-registered product 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 2009 with a seasonal influenza vaccine.

          -  Chronic administration 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 clinically significant pulmonary, cardiovascular, hepatic, renal, neurological
             and psychiatric disorders, as determined by clinical evaluation or pre-existing
             laboratory screening tests.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature >=37.5°C on oral setting.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the administration of the study vaccine or planned administration during the
             study.

          -  Any medical conditions in which IM injections are contraindicated

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.