NCT00474266

Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days. Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days. For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK134612 (Nimenrix)	Single dose intramuscular injection
BIOLOGICAL	Priorix-Tetra	2-dose subcutaneous injection
BIOLOGICAL	Meningitec	Single dose intramuscular injection

Timeline

• Start date: 2007-06-05
• Primary completion: 2008-02-26
• Completion: 2008-03-26
• First posted: 2007-05-16
• Last updated: 2019-11-18
• Results posted: 2017-12-15

Locations

14 sites across 1 country: Finland