At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III, Partially Double-blind Study to Evaluate Consistency and Immunogenicity of 3 Lots of GSK Biologicals' Hib Conjugate Vaccine 208108 Versus ActHIB and Pentacel at 2, 4, 6 and 15-18 Months of Age in Healthy Infants
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108), ActHIB™, and 6 other interventions for Haemophilus Influenzae Type b. Completed, enrolled 4,003 participants across 63 sites.
Detailed Summary
The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.
Study Details
Timeline
Interventions
Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
Two oral doses in primary epoch at 2 and 4 months of age
Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection
One dose in the booster epoch at 15-18 months of age as intramuscular injection