Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Biologicals' influenza vaccine GSK1557482A; Vaxigrip
Intervention description: one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).; one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 390.0
Sex: All
Minimum age: 6 Months
Maximum age: 36 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Flu; Safety; Immunogenicity; Flu vaccine; Influenza; Virus

Summary:

      Children younger than 5 years of age are at high risk for severe influenza disease (flu) and
      hospitalization due to flu. Scientists are in the process of re-evaluating the dosing
      initially based on whole virus vaccines to improve their efficacy in infants. In this study,
      we will compare two different dose levels of GSK1557482A flu vaccine. Another already
      approved flu vaccine made by a different company will be used as a control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female child 6 months to < 3 years of age at the time of the vaccination,
             regardless of previous administration of influenza vaccine in a previous season;

          -  Subjects must be in good health established by medical history and physical
             examination before entering into the study;

          -  Subjects having a parent/guardian who the investigator believes can and will comply
             with the requirements of the protocol should be enrolled in the study;

          -  Written informed consent obtained from the subject's parent/guardian.

          -  Parents/guardian access to a consistent means of telephone contact, land line or
             mobile

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the administration of the study vaccine or planned use during the study
             period. Routine, registered childhood vaccinations are not an exclusion criterion;

          -  History of hypersensitivity to any vaccine;

          -  History of allergy to or reactions likely to be exacerbated by, any component of the
             vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;

          -  History of any congenital, acquired, or iatrogenic immunodeficiency state (current or
             potential) including HIV infection, disorders of the lymphoid system or bone marrow,
             or chronic administration (defined as more than 14 consecutive days) of
             immunosuppressant or other immune-modifying drugs within 3 months prior to the
             administration of the study vaccine.

          -  Acute disease at the time of enrolment.

          -  History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated
             influenza virus vaccine;

          -  Any significant disorder of blood coagulation or treatment with vitamin K antagonists;
             or any known disorder of hemostasis;

          -  Receipt of any immunoglobulins and/or any blood products within three months of study
             enrollment or planned administration of any of these products during the study period.

          -  Receipt of a non-study related influenza vaccine outside of this study and during the
             current (2008-09) influenza immunization campaign.

          -  Any use of analgesics/antipyretics 12 hours before receipt of vaccine.