NCT00327184

Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 709 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Neisseria Meningitidis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)	Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
BIOLOGICAL	Infanrix Penta	Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
BIOLOGICAL	Infanrix hexa	Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
BIOLOGICAL	Neis-Vac-C	Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-05-18
• Last updated: 2016-10-07

Locations

16 sites across 2 countries: Finland, Italy