NCT00508261

Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 793 (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 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™. For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination. For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK134612	Single dose intramuscular injection
BIOLOGICAL	Infanrix™ hexa	Single dose intramuscular injection
BIOLOGICAL	Meningitec™	Single dose intramuscular injection

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-05-26
• Completion: 2008-10-27
• First posted: 2007-07-27
• Last updated: 2019-01-24
• Results posted: 2019-01-24

Locations

89 sites across 3 countries: Austria, Germany, Greece