NCT01144663

Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

Immunogenicity and Safety of GSK Biologicals' Meningococcal Vaccine (GSK 134612) When Co-administered With a Pneumococcal Conjugate Vaccine and Infanrix Hexa™ in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,095 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.

Detailed description

The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2.

Conditions

• Infections, Meningococcal
• Meningococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Nimenrix™	4- or 3-dose intramuscular injection
BIOLOGICAL	Menjugate®	3-dose intramuscular injection
BIOLOGICAL	NeisVac-CTM	3-dose intramuscular injection
BIOLOGICAL	Infanrix™ hexa	4-dose intramuscular injection
BIOLOGICAL	Synflorix™	4-dose intramuscular injection

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-06-22
• Completion: 2013-09-10
• First posted: 2010-06-15
• Last updated: 2020-12-31
• Results posted: 2019-02-01

Locations

44 sites across 3 countries: Estonia, Germany, Spain