Haemophilus Influenzae Type b Clinical Trial
Official title:
Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC Given With Infanrix™ Penta Versus NeisVac-C™ Given With Infanrix™ Hexa at 3, 5 Months of Age and Persistence Prior to a Hib-MenC Booster at 11 Months and Immunogenicity of the Booster
The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two
doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants
(at 3 & 5m) compared to NeisVac-C™ given with Infanrix™ hexa.
The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and
reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m
of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence
prior to the administration of the booster doses. The Protocol Posting has been updated in
order to comply with the FDA Amendment Act, Sep 2007.
This multicenter study is open and consists of a primary and a booster phase. The study has 2 treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase, one blood sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose. In the booster phase, two blood samples will be collected: prior to and one month post booster vaccination. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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