Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza vaccine GSK2321138A; Fluarix™
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 599.0
Sex: All
Minimum age: 18 Months
Maximum age: 47 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; Influenza

Summary:

      The purpose of the present study is to assess the immunogenicity and safety of vaccine
      GSK2321138A in children.
    

Eligibility criteria:

        Inclusion Criteria:

        For all subjects:

          -  Subjects who the investigator believes that they and/or their Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol.

          -  Written informed consent obtained from the subject/from the LAR(s).

        For unprimed subjects:

          -  A male or female child aged 18 to 47 months at the time of the first vaccination.

          -  Children who did not have influenza vaccine in a previous season.

        For primed subjects from study NCT00764790:

        • Children who received Fluarix™ in the 111751 study NCT00764790.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  History of hypersensitivity to any vaccine.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting one month before and ending 28 days after each dose of
             vaccine(s).

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by medical history and physical examination.

          -  Acute disease at the time of enrolment.

          -  History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated
             influenza virus vaccine.

          -  Receipt of another seasonal influenza vaccine outside of this study, during current
             (2009-2010) flu season.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccination Inhaled and topical steroids are allowed.

          -  Administration of immunoglobulins and/or blood products within the 3 month preceding
             the first dose of study vaccine or planned administration during the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product.