A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix/Influsplit SSW 2012-2013
Intervention description: 1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Healthy; Immunogenicity; Elderly; Safety; Adults

Summary:

      The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
      trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in
      adults (18 to 60 years) and in elderly (over 60 years).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  A male or female aged 18 years or above at the time of vaccination.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects or subjects with well-controlled chronic diseases as established by
             medical history and clinical examination before entering the study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the dose of study vaccine, or planned use during the study
             period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             the six months prior to vaccination. Inhaled and topical steroids are allowed.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the administration of the study vaccine or planned administration during the
             study period.

          -  Administration of an influenza vaccine within the six months preceding the study
             vaccination.

          -  Planned administration/ administration of a vaccine other than the study vaccine
             within 30 days before study vaccination and during the entire study period.

          -  Clinically or virologically confirmed influenza infection within the six months
             preceding the study vaccination.

          -  Acute disease and/or fever at the time of enrolment.

          -  Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, as determined by physical examination or laboratory screening tests.

          -  Chronic underlying disease, not stabilized or clinically serious.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of Guillain-Barré syndrome.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Anaphylaxis following the administration of vaccine(s).

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participating in the study.