Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK investigational FluNG vaccine GSK2186877A, aged lot; GSK investigational FluNG vaccine GSK2186877A, fresh lot
Intervention description: Single dose, intramuscular injection; Single dose, intramuscular injection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 726.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2186877A

Summary:

      The objective of the study is to evaluate immunogenicity between different formulations of
      GSK Biologicals' investigational vaccine GSK2186877A.
    

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. Specific attention
             should be given to the compliance potential of subjects with suspected or known drug
             or alcohol abuse.

          -  A man or woman 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 before entering into the study.

        Exclusion Criteria:

          -  Any confirmed or suspected influenza illness within the last 6 months.

          -  Previous vaccination against influenza with any seasonal vaccine since December 2008.

          -  Planned administration of an influenza vaccine other than the study vaccines during
             the entire study period.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the 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 Visit 2.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the dose of study vaccine or planned administration during the study period.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within six months prior to the vaccine dose. For
             corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled
             and topical steroids are allowed.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s) including egg and chicken protein, included history of
             hypersensitivity to a previous dose of influenza vaccine.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or 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 (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

          -  Any medical conditions in which intramuscular injections are contraindicated.