NCT01000974

Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,003 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

This protocol posting has been updated following protocol amendment 3, dated 12 April 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

Conditions

• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)	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.
BIOLOGICAL	ActHIB™	Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
BIOLOGICAL	Pentacel™	Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
BIOLOGICAL	Pediarix™	Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
BIOLOGICAL	Prevnar 13™	Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
BIOLOGICAL	Rotarix™	Two oral doses in primary epoch at 2 and 4 months of age
BIOLOGICAL	Engerix™-B	Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection
BIOLOGICAL	Infanrix™	One dose in the booster epoch at 15-18 months of age as intramuscular injection

Timeline

• Start date: 2010-06-18
• Primary completion: 2011-11-18
• Completion: 2013-07-17
• First posted: 2009-10-23
• Last updated: 2018-07-12
• Results posted: 2013-08-19

Locations

63 sites across 1 country: United States