Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Adjuvanted pandemic influenza candidate vaccine; Fluarix; Placebo
Intervention description: 2 doses, intramuscular injection; One intramuscular injection; One intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 5075.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adjuvanted pandemic influenza candidate vaccine; Influenza

Summary:

      Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian
      virus. Prevention and control will depend on the rapid production and worldwide distribution
      of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and
      tested in clinical trials to determine the most optimal formulation and the best vaccination
      schedule. This study is designed to test in healthy adults aged above 18 years the
      reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1
      vaccine formulated from Split Virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A male or female aged 18 years or above at the time of the first vaccination.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects 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, for 30 days prior
             to first vaccination, have a negative pregnancy test and must agree to continue such
             precautions for two 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 the second
             vaccination.

          -  Administration of interpandemic influenza vaccine between Day 0 and Day 51of the
             study. Those study participants belonging to risk groups eligible to receive the
             annual interpandemic influenza vaccine (in accordance with local regulations) can
             receive the annual vaccination after day 51 and before the end of the study on Day
             180.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within 6 months prior to the first administration of the study
             vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  History of chronic alcohol consumption and/or drug abuse.

          -  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.

          -  Major congenital defects or serious chronic disease including any medically
             significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or
             metabolic disorder, as determined by medical history and physical examination.
             (Subjects suffering from seasonal allergies or asthma under inhalative treatment can
             be included).

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first administration of the study vaccine or during the study.

          -  Lactating women

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days prior to the first vaccination, or planned use during
             the study period.