Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Pandemic Influenza Vaccine (GSK1562902A); Fluarix™
Intervention description: 2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.; 2 doses, intramuscular injection on Days 0 and 21.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 3 Years
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Pandemic Influenza Vaccine (GSK1562902A)

Summary:

      The present study is designed to evaluate in children (aged between 3 and 9 years) the
      immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A)
      administered following a two-administration schedule (21 days apart). Subjects in the control
      group will receive Fluarix. The Protocol Posting has been updated in order to comply with the
      FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  Children aged between and including 3 and 9 years of age at the time of first
             vaccination.

          -  Written informed consent obtained from the parent(s) or guardian of the subject.

          -  Healthy children as established by medical history and clinical examination before
             entering the study.

          -  Subjects who are likely to reside in the vicinity of the study center for the duration
             of the study.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             investigational vaccine within 30 days prior to the enrolment in this study, or
             planned use during the study period.

          -  Administration of 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, with the exception of routine childhood inoculations which cannot be
             delayed, but which must not be administered on the same day as the investigational
             vaccine candidate.

          -  Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to
             Day 51.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the enrolment in this study.

          -  Any chronic drug therapy to be continued during the study period, with the exception
             of inhalative treatment for seasonal allergies or asthma.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by medical history and physical examination.

          -  History of hypersensitivity to vaccines.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines used in this study.

          -  History of any neurological disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             prior to the enrolment in this study or planned during the study.

          -  Any condition which, in the opinion of the investigator, renders the subject unfit for
             participation in the study