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

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).

Timeline

Start

2013-05-03

Primary completion

2014-07-03

Completion

2016-04-20

Publications

• Nolan T, Booy R, Marshall HS, Richmond P, Nissen M, Ziegler JB, Baine Y, Traskine M, Jastorff A, Van der Wielen M. Immunogenicity and Safety of a Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine 6 Years After MenC Priming as Toddlers. Pediatr Infect Dis J. 2019 Jun;38(6):643-650. doi: 10.1097/INF.0000000000002334.

Drugs

Indications