A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FluLaval® Quadrivalent; Havrix™
Intervention description: One intramuscular dose for primed subjects. Two intramuscular doses for unprimed subjects.; Two intramuscular doses for primed subjects. Three intramuscular doses for unprimed subjects.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5220.0
Sex: All
Minimum age: 3 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      This study is designed to test the efficacy of an investigational influenza vaccine, in
      children compared to Havrix®, a licensed Hepatitis A virus vaccine.

      This study will also evaluate the immunogenicity and safety of the investigational vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parent(s) or legally
             acceptable representative(s) can and will comply with the requirements of the
             protocol.

          -  A male or female child aged between 3 and 8 years inclusive at the time of the first
             vaccination; children are eligible regardless of history of administration of
             influenza vaccine in a previous season. However, subjects who have received any
             seasonal or pandemic influenza vaccine within 6 months preceding the first dose of
             study vaccine will not be enrolled.

          -  Written informed consent obtained from the subject/from the parent(s)/legally
             acceptable representative(s) of the subject.

          -  Written assent obtained from the subject if/as required by local regulations.

          -  Subjects in stable health as determined by investigator's clinical examination and
             assessment of subjects' medical history.

          -  Access to a consistent means of telephone contact

        Exclusion Criteria:

          -  Child in care.

          -  Use of an investigational or non-registered product other than the study vaccines
             within 30 days before study vaccination or planned use during study period. Routine
             registered childhood vaccinations are permitted.

          -  Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding
             the first dose of study vaccine, or planned use of such vaccines during the study
             period. Prior receipt of more than one dose of a licensed hepatitis A vaccine, with
             the first dose administered at >=12 months of age.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within 6
             months prior to the first vaccine dose.

          -  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.

          -  History of Guillain-Barre syndrome within 6 weeks of receipt of prior influenza virus
             vaccine.

          -  Any known or suspected allergy to any constituent of influenza vaccines ; a history of
             anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse
             reaction to a previous influenza vaccine.

          -  Fever at the time of enrolment.

          -  Acute disease at the time of enrolment.

          -  Any significant disorder of coagulation or treatment with Coumadin derivatives or
             heparin.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Ongoing aspirin therapy.

          -  Any other condition which, in the opinion of the Investigator, prevents the subject
             from participating in the study.