NCT00129129

Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine

Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 756 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 15 Months
• Healthy volunteers: Accepted

Summary

This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age. The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.

Detailed description

The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US. All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized. MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine	Primary phase: 3 IM doses Booster phase: 1 IM dose
BIOLOGICAL	ActHIB	Primary phase: 3 IM doses Booster phase: 1 IM dose
BIOLOGICAL	Pediarix	Primary phase: 3 IM doses
BIOLOGICAL	Prevnar	Primary phase: 3 IM doses Booster phase: 1 IM dose
BIOLOGICAL	Menomune	Primary phase: 1 SC dose

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-09-15
• Completion: 2006-03-29
• First posted: 2005-08-11
• Last updated: 2018-08-24
• Results posted: 2013-12-30

Locations

27 sites across 1 country: United States