NCT01340898

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK 134612) When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 753 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

Detailed description

This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.

Conditions

• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK 134612	Intramuscular injection
BIOLOGICAL	SynflorixTM	Intramuscular injection
BIOLOGICAL	Infanrix-IPV/HiberixTM	Intramuscular injection

Timeline

• Start date: 2012-01-27
• Primary completion: 2014-08-04
• Completion: 2015-10-19
• First posted: 2011-04-25
• Last updated: 2019-08-06
• Results posted: 2019-08-06

Locations

2 sites across 2 countries: Lebanon, Mexico