NCT00465816

Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

Non-inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals' Twinrix™ Versus 134612 Alone and Twinrix™ Alone in Healthy Subjects Aged 11 Through 17 Years.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 611 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.

Detailed description

All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken. 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	Nimenrix (Meningococcal vaccine 134612)	Single dose intramuscular injection
BIOLOGICAL	Twinrix	3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.

Timeline

• Start date: 2007-04-11
• Primary completion: 2008-04-28
• Completion: 2008-04-28
• First posted: 2007-04-25
• Last updated: 2018-06-08
• Results posted: 2012-05-22

Locations

6 sites across 2 countries: Denmark, Sweden