Influenza Clinical Trial
Official title:
Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
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.
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.
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