Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A; Fluarix
Intervention description: Single dose, Intramuscular injection, 8 different formulations were tested (one per group); Single dose, Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2007.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine GSK576389A; Influenza infection; Fluarix

Summary:

      In order to find the formulation leading to a maximal increase of the immune response while
      maintaining an acceptable safety profile, this study is designed to evaluate the
      immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals'
      influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
    

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.

          -  A male or female aged 18-40 years old or 65 years or older at the time of the
             vaccination.

          -  Written informed consent obtained from the subject.

          -  Free of an acute aggravation of the health status as established by clinical
             evaluation (medical history and medical history directed 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:

          -  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 during the
             entire study period.

          -  Planned administration of an influenza vaccine other than the study vaccines during
             the entire study period.

          -  Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007
             influenza vaccine).

          -  Administration of more than 14 days of immunosuppressants or other immune-modifying
             drugs within 6 months prior to the administration of the study vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Hypersensitivity to a previous dose of influenza vaccine.

          -  Allergy to any component of the vaccine.

          -  Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality.

          -  Acute disease at the time of enrolment. (Acute disease is defined as the presence of a
             moderate or severe illness with or without fever. All vaccines can be administered to
             persons with a minor illness such as diarrhoea, mild upper respiratory infection with
             or without low-grade febrile illness, i.e. axillary temperature<37.5ºC (99.5ºF).

          -  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 IM injections are contraindicated.

          -  Lactating female or female planning to become pregnant or to discontinue contraceptive
             precautions