NCT01777308

Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination

The Vaccine Response and Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine (GSK134612) Administered as One Dose at 6 Years Post-MenC Primary Vaccination in Healthy Subjects Aged 12-18 Months at Primary Vaccination

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 84 Months – 95 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination. This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal conjugate vaccine GSK134612	Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm

Timeline

• Start date: 2013-05-03
• Primary completion: 2014-07-03
• Completion: 2016-04-20
• First posted: 2013-01-28
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

8 sites across 1 country: Australia