Comparison of the Safety and Immunogenicity of a Novel Quadrivalent Meningococcal ACWY-Tetanus Toxoid Conjugate Vaccine and a Marketed Quadrivalent Meningococcal ACWY-Diphtheria Toxoid Conjugate Vaccine in Healthy Individuals 10-25 Years of Age

Scott A Halperin; Yaela Baine; Joseph B Domachowske; Naresh Aggarwal; Michael Simon; Joanne M Langley; Shelly A McNeil; Leonard R Friedland; Veronique Bianco; Carmen I Baccarini; Jacqueline M Miller

doi:10.1093/jpids/pit058

Comparison of the Safety and Immunogenicity of a Novel Quadrivalent Meningococcal ACWY-Tetanus Toxoid Conjugate Vaccine and a Marketed Quadrivalent Meningococcal ACWY-Diphtheria Toxoid Conjugate Vaccine in Healthy Individuals 10-25 Years of Age

J Pediatric Infect Dis Soc. 2014 Mar;3(1):33-42. doi: 10.1093/jpids/pit058. Epub 2013 Oct 17.

Affiliations

¹ Departments of Pediatrics and Medicine, Canadian Center for Vaccinology, Dalhousie University, Capital Health and the IWK Health Centre, Halifax, Nova Scotia, Canada scott.halperin@dal.ca.
² GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
³ Department of Pediatrics, SUNY Upstate Medical Center, Syracuse, New York.
⁴ Findagate Medical Centre, Brampton, Ontario, Canada.
⁵ Pediatric and Adolescent Medicine, Nicholasville, Kentucky.
⁶ Departments of Pediatrics and Medicine, Canadian Center for Vaccinology, Dalhousie University, Capital Health and the IWK Health Centre, Halifax, Nova Scotia, Canada.
⁷ GlaxoSmithKline Vaccines, Wavre, Belgium.

Abstract

Background: Universal immunization of adolescents against meningococcal disease with a quadrivalent meningococcal ACWY (MenACWY) conjugate vaccine is recommended in a number of countries.

Methods: In a randomized, controlled, observer-blinded, multicenter trial, 1016 participants, 10-25 years of age, were randomly allocated 1:1:1 to receive a single dose of 1 of 2 lots of an investigational tetanus toxoid-conjugated MenACWY vaccine (MenACWY-TT) or a marketed diphtheria toxoid-conjugated MenACWY vaccine (MenACWY-DT). The primary outcome was the noninferiority of the vaccine response after MenACWY-TT (lot A) compared with MenACWY-DT for all 4 serogroups. Vaccine response was defined as a postvaccination human serum bactericidal antibody (hSBA) titer against each of the serogroups of at least 1:8 in persons initially seronegative (<1:4) or as a 4-fold increase in titer pre- to postvaccination in persons initially seropositive (≥1:4). Adverse events (AEs) after immunization were measured 4 and 31 days postvaccination.

Results: The mean age of participants was 16.3 years; 977 (96.6%) completed the study. The noninferiority of MenACWY-TT (lot A) to the control vaccine in terms of the percentage of participants with hSBA vaccine response was demonstrated for each serogroup. Vaccine response rates ranged from 51.0% to 82.5% for the 4 serogroups after MenACWY-TT (both lots) compared with 39.0%-76.3% for the 4 serogroups after MenACWY-DT. Pain was the most common injection-site reaction reported by 50.8%-55.4% across the 3 groups. Fatigue and headache were the most common systemic solicited AEs, reported by 27.3%-29.2% and 25.5%-26.4%, respectively.

Conclusions: Tetanus toxoid-conjugated MenACWY vaccine was well tolerated and elicited an immune response that was noninferior to that of a marketed MenACWY-DT (www.clinicaltrials.gov NCT01165242).

Keywords: Neisseria meningitidis; meningococcal conjugate vaccine; vaccine immunogenicity; vaccine safety.

Associated data

ClinicalTrials.gov/NCT01165242