Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' influenza vaccine GSK2186877A; GSK Biologicals' Fluarix
Intervention description: One intramuscular injection at Day 0; One intramuscular injection at Day 0
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Elderly; Influenza

Summary:

      This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine
      GSK2186877A in people aged 65 years or older.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy 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 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.

        Elderly adults:

        • A man or woman 65 year of age or older at the time of the first vaccination.

        Young adults:

          -  Man or woman between the ages of 18 and 40 years, inclusive.

          -  If the subject is female, she must be of non-childbearing potential or be
             post-menopausal, 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 vaccination.

        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 4 after vaccination and of
             an influenza vaccine other than the study vaccines up to Visit 4.

          -  Vaccination against influenza since February 2008 with a seasonal influenza vaccine.

          -  Previous vaccination in the last three years with an investigational adjuvanted
             vaccine candidate seasonal or pandemic 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 hypersensivity 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 or chicken protein.

          -  Acute (active) 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.

          -  Pregnant or lactating female.

          -  Female of childbearing age planning to become pregnant or planning to discontinue
             contraceptive precautions.

          -  Any medical condition that in the opinion of the investigator precludes the collection
             of blood volumes as required by the protocol.