Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' investigational vaccine GSK1562902A
Intervention description: Three intramuscular injections
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were to be stratified into three age strata (6 to 11 months, 12 to 23 months and 24 to 35 months) in the ratio of 2:1:1.
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H5N1; influenza infection; Influenza vaccine GSK1562902A

Summary:

      The objective of the study is to evaluate the immunogenicity and safety of prime-boost
      vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that parents/Legally Acceptable Representatives
             (LARs) can and will comply with the requirements of the protocol.

          -  Children, male or female between, and including, 6 and 35 months of age at the time of
             first study vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Healthy children as established by medical history and clinical examination before
             entering the study.

          -  Parent/LAR access to a consistent means of telephone contact, land line or mobile, but
             NOT a pay phone or other multiple-user device.

          -  Subjects who are likely to reside in the vicinity of the study centre for the duration
             of the study. In studies using the home-based model for vaccination and follow-up,
             subjects who are likely to remain in the vicinity of the area where they were
             recruited.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Planned administration of any vaccine 30 days prior and 21 days after any study
             vaccine administration.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines such as egg protein or thiomersal.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of any neurological disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory tests.

          -  Administration of immunoglobulins and/or any blood products within the three months
             prior to the enrolment in this study, or planned administration during the study
             period.

          -  Any condition which, in the opinion of the investigator, renders the subject unfit for
             participation in the study.

          -  Child in care.

          -  Previous vaccination at any time with an H5N1 vaccine.

          -  Medical history of physician-confirmed infection with a H5N1 virus.