The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
450
GSK Investigational Site
Jarvenpaa, Finland
GSK Investigational Site
Oulu, Finland
GSK Investigational Site
Pori, Finland
GSK Investigational Site
Tampere, Finland
GSK Investigational Site
Turku, Finland
GSK Investigational Site
Vantaa, Finland
Antibody concentration/response to all vaccine antigens after vaccination
Solicited (D0-3); unsolicited events (D0-30); serious adverse events (SAEs) (full study)
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