Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix; Fluarix-AS25; Fluarix-AS50; Fluarix-AS01B; Fluarix-AS01E
Intervention description: 1 dose administered intramuscularly in the deltoid region of the non-dominant arm; 1 dose administered intramuscularly into the deltoid region of the non-dominant arm; 1 dose administered intramuscularly into the deltoid region of the non-dominant arm; 1 dose administered intramuscularly into the deltoid region of the non-dominant arm; 1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy
      adults, probably as a result of immunosenescence, there is a desire to devise ways to
      increase the current vaccines efficacy for this target population. Adjuvants are known to
      boost immune responses, thus representing one way to increase the efficacy of the current
      GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is
      to evaluate the immunogenicity and the reactogenicity of a vaccination with four different
      adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For
      immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly
      aged 65 years and older will receive Fluarix™ and form the control groups of this trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female aged between 18 and 40 years or aged 65 years or older at the time of
             the vaccination.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the administration of the study vaccine, or
             planned use during the study period.

          -  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.

          -  History of confirmed influenza infection since a year from the date of previous
             vaccination.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  History of hypersensitivity to vaccines.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, as determined by physical examination or 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 during the study.