Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK investigational vaccine GSK1557482A; Fluzone®
Intervention description: One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects; One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2116.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Biologicals influenza vaccine GSK1557482A; influenza infection

Summary:

      The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational vaccine GSK1557482A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the
             investigator believes can and will comply with the requirements of the protocol.

          -  A male or female child aged between 3 years and 17 years of age at the time of the
             first vaccination; children who may or may not have had previous administration of
             influenza vaccine in a previous season are acceptable.

          -  Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the
             subject.

          -  Healthy subjects as established by medical history and history-directed clinical
             examination before entering into 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 the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the administration of the study vaccine, or planned use
             during the study period. Routine, registered childhood vaccinations or registered and
             recommended pandemic influenza vaccine are not an exclusion.

          -  Receipt of a seasonal influenza vaccine outside of this study, during current
             (2009-2010) flu season.

          -  Child in care

          -  Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any
             other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
             Topical, intra-articular or inhaled glucocorticoids are allowed.

          -  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.

          -  History of hypersensitivity to any vaccine.

          -  History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated
             influenza virus vaccine.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  Acute disease and/or fever at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Pregnant or lactating female.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.