A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix™/Influsplit SSW®
Intervention description: single intramuscular dose on Day 0
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      This study is designed to test the immunogenicity and reactogenicity of the
      FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for
      the 2009-2010 season.
    

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 years or above at the time of the vaccination.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects or with well-controlled chronic diseases 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 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 other than the study vaccine(s)
             within 30 days preceding the vaccination or planned use during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the vaccine dose.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the administration of the study vaccine or planned during the study.

          -  Administration of an influenza vaccine within 6 months preceding the study start.

          -  Administration of an influenza vaccine other than the study vaccine during the entire
             study

          -  Clinically or virologically confirmed influenza infection within 6 months preceding
             the study start

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at the time of enrolment.

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, as determined by physical examination or laboratory screening tests.

          -  Not stabilized or clinically serious chronic underlying disease.

          -  Lactating female.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participation in the study.