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

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.

Timeline

Start

2013-01-10

Primary completion

2014-01-16

Completion

2014-01-16

Outcome

Mixed primary results

paper was demonstrated in terms of rSBA geometric mean titers (GMTs) for 4 meningococcal serogroups PMID 29960800 ↗

paper and of the percentage of participants with antibody concentrations >1 IU/ml for D and T. PMID 29960800 ↗

paper Among the pertussis antigens, non-inferiority criteria for geometric mean concentrations (GMCs) were reached for PT, but not met for FHA and PRN. PMID 29960800 ↗

Publications

• Rivera L, Schwarz TF, Kim KH, Kim YK, Behre U, Cha SH, Jo DS, Lee J, Lee JS, Cheuvart B, Jastorff A, Van der Wielen M. Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: A phase III, randomized study. Vaccine. 2018 Jul 25;36(31):4750-4758. doi: 10.1016/j.vaccine.2018.04.034. Epub 2018 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Boostrix	Vaccine	—	Intramuscular
Subject	GSK134612	Vaccine	—	Intramuscular

Indications