Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK pandemic vaccine GSK2340272A
Intervention description: 2 intramuscular injections
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 3 Years
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A

Summary:

      The objective of this study is to evaluate the safety and immunogenicity study of GSK
      Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol.

          -  Children, male or female, aged between 3 and 9 years at the time of first study
             vaccination.

          -  Written informed consent obtained from the parent(s) or LAR(s) of the subject.

          -  Healthy children, as established by medical history and clinical examination when
             entering the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of the study vaccine or planned use during the
             study period.

          -  Clinically or virologically confirmed influenza infection within six months preceding
             the study start.

          -  Planned administration of any vaccine 30 days prior and 30 days after any study
             vaccine administration.

          -  Have received any seasonal flu vaccine since last year.

          -  Previous administration of any H1N1 A/California-like vaccine

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             three months prior to enrolment in this study or planned administration during the
             study period. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or
             equivalent. Inhaled and topical steroids are allowed.

          -  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.

          -  History of any neurological disorders or seizures.

          -  Acute disease and/or fever at the time of enrolment:

               -  Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting,
                  or >= 38°C on rectal setting.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

          -  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.

          -  Child in Care.