NCT00427908

Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612

Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects (1-10 Years of Age)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 613 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Accepted

Summary

This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination. Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.

Detailed description

Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)	One intramuscular dose.
BIOLOGICAL	Mencevax™ ACWY	One subcutaneous dose.
BIOLOGICAL	Meningitec™	One intramuscular dose.

Timeline

• Start date: 2007-02-07
• Primary completion: 2007-12-03
• Completion: 2007-12-03
• First posted: 2007-01-29
• Last updated: 2018-06-04
• Results posted: 2018-06-04

Locations

11 sites across 1 country: Finland