NCT00326118

Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.

Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC With Priorix™, Versus MenC-CRM197 Vaccine With Hiberix™ & Priorix™ in Toddlers Primed With Hib But Not MenC & to Evaluate Persistence up to 5 Years After Vaccination.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

Summary

The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines. In the extension phase, at Years 1, 2, 3, 4 \& 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially available MenC vaccine as active controls. Priorix™ is given concomitantly in both groups. In the primary phase, two blood samples are taken from all subjects for immunogenicity analyses: before and one month after vaccination. In the extension phase, at Year 1, 2, 3, 4 \& 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase.

Conditions

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	Haemophilus influenzae type b and meningococcal serogroup C (vaccine)	One intramuscular dose at 12-18 months of age
BIOLOGICAL	Priorix™	One subcutaneous dose at 12-18 months of age
BIOLOGICAL	Hiberix™	One intramuscular dose at 12-18 months of age.
BIOLOGICAL	Meningitec™	One intramuscular dose at 12-18 months of age

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-11-01
• Completion: 2007-11-06
• First posted: 2006-05-16
• Last updated: 2018-08-24
• Results posted: 2009-10-23

Locations

7 sites across 1 country: Australia