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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a study of two different dose levels of a new formulation of flu vaccine for the
      2008/2009 flu season using the World Health Organization recommended virus strains. Subjects
      will be randomly put into one of three different groups to receive either one or two doses
      of:

      0.25 mL dose of the new flu vaccine, or 0.5 mL dose of the new flu vaccine or the licensed
      Vaxigrip flu vaccine (control) The parents of the subjects and the study doctor and nurses
      will not know the group of their child until the study is completed.

      The children will be vaccinated with either one dose or two doses depending on whether or not
      they have received a flu vaccine before. The doctor will decide on the schedule for each
      child based on the information provided by the parents. The active phase of the study will
      last approximately two months for children receiving two doses and one month for those
      receiving a single dose. An extended safety follow-up will continue until Study Month 6.

      Two blood samples will be taken from each subject. These will be used to evaluate how well
      the vaccine works in the children and which dose level works best compared to the control.

      The parents will fill in a diary card for four days to record any reactions or symptoms which
      may occur after vaccination. Parents will also keep a record of other symptoms that may occur
      between vaccinations and up to six months after the first vaccination and will keep a record
      of any medication their child takes in this time period.
    

Intervention name(s): GSK Biologicals' influenza vaccine GSK1557482A; Vaxigrip
Intervention type(s): Biological; Biological
Intervention description(s): 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).
Other intervention name(s): Fluviral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Flu; Safety; Immunogenicity; Flu vaccine; Influenza; Virus