Influenza Clinical Trial
Official title:
An Observer-blind, Dose Ranging Safety and Immunogenicity Study of GSK Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age
The purpose of this study is to assess the safety and immunogenicity of different formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35 months of age.
Safety and immunogenicity of different formulations administered as a 2-dose schedule in
children 6-35 months of age will be evaluated. In addition, the quality of the 2-dose priming
will be assessed through the anamnestic response elicited by an antigen challenge
(unadjuvanted H5N1) administered 12 months later. The persistence of the immune response
approximately 12 months (Day 385) after dose 2 will also be evaluated.
Subjects from each group will be enrolled into the CMI sub-cohort comprising of approximately
100 subjects. Within the participating country(ies), these subjects will be enrolled in only
selected/qualified sites.
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