NCT00263653

Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197

Study to Evaluate the Safety, Reactogenicity & Immunogenicity of a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™, vs Hib-MenC or Priorix™ Only, in Toddlers (13-14 m) Primed With 3 Doses of Hib (as Part of a DTPa -Containing Vaccine) & MenC-CRM197 Conjugate Vaccines.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 13 Months – 14 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa -containing vaccine) and MenC-CRM197.

Detailed description

This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). Hib-MenC-TT and Priorix™, when given separately, serve as active controls. Two blood samples are taken: before and one month after vaccination. Additional vaccines are offered at study end in order to complete the vaccine schedule recommended in Spain

Conditions

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	Haemophilus influenzae type b- and meningococcal (vaccine)

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-03-01
• Completion: 2005-09-01
• First posted: 2005-12-09
• Last updated: 2016-09-21

Locations

16 sites across 1 country: Spain