NCT01767376

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age

Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Healthy Adolescents and Young Adults Between 11 and 25 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 692 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy adolescents and young adults.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK134612	One dose administered intramuscularly (IM) in the deltoid muscle of the arm.
BIOLOGICAL	Boostrix®	One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).

Timeline

• Start date: 2013-01-10
• Primary completion: 2014-01-16
• Completion: 2014-01-16
• First posted: 2013-01-14
• Last updated: 2017-09-06
• Results posted: 2017-09-06

Locations

15 sites across 3 countries: Dominican Republic, Germany, South Korea

Regulatory

• FDA-regulated drug study