NCT00674583

Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children

Non-inferiority of GSK Biologicals' Meningococcal Vaccine (GSK134612) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.

Detailed description

The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals' meningococcal vaccine GSK134612	Intramuscular administration, 1 dose
BIOLOGICAL	Menjugate	Intramuscular administration, 1 dose

Timeline

• Start date: 2008-05-09
• Primary completion: 2008-09-02
• Completion: 2009-01-08
• First posted: 2008-05-08
• Last updated: 2019-11-18
• Results posted: 2017-10-19

Locations

31 sites across 2 countries: France, Germany