Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza vaccine GSK2186877A; GSK Biologicals' Fluarix™
Intervention description: One intramuscularly injection at Day 0; One intramuscularly injection at Day 0
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 971.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Elderly; Vaccine; Influenza

Summary:

      The purpose of this observer-blind clinical trial is to evaluate the safety and
      immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly.
      Subjects were previously vaccinated (NCT00529516).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >=
             65 years and 18-41 years of age groups and having received the study vaccine.

          -  Subjects of whom the investigator believes that they can and will comply with the
             requirements of the protocol. Specific attention should be given to the compliance
             potential of subjects with suspected or known drug or alcohol abuse.

          -  Written informed consent obtained from the subject.

          -  Free of an acute aggravation of the health status as established by medical history
             and clinical examination 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:

          -  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 30 days
             after vaccination.

          -  Planned administration of an influenza vaccine other than the study vaccines during
             the entire study period.

          -  Any vaccination against influenza since January 2008 with any seasonal influenza
             vaccine.

          -  Chronic administration (defined as more than 14 days) 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
             vaccines.

          -  Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by 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 administration of the study vaccine or planned administration during the
             study period.

          -  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.

          -  Any medical conditions in which intramuscular injections are contraindicated.

          -  Pregnant or lactating females.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.