NCT00614614

Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014

Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,558 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Detailed description

The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone. Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study. The protocol posting has been updated following a protocol amendment.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)	One dose in the booster phase as intramuscular injection
BIOLOGICAL	GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)	Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection
BIOLOGICAL	Infanrix®	One dose as intramuscular injection
BIOLOGICAL	ActHIB®	Three doses in the priming phase as intramuscular injection
BIOLOGICAL	Pediarix®	Three doses in the priming phase as intramuscular injection

Timeline

• Start date: 2008-02-13
• Primary completion: 2009-07-31
• Completion: 2009-09-17
• First posted: 2008-02-13
• Last updated: 2018-09-21
• Results posted: 2012-07-20

Locations

56 sites across 1 country: United States