title: 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.
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).
authors.affiliation: 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.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Halperin
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Yaela
authors.initials: Y
authors.lastname: Baine
authors.affiliation: Department of Pediatrics, SUNY Upstate Medical Center, Syracuse, New York.
authors.forename: Joseph B
authors.initials: JB
authors.lastname: Domachowske
authors.affiliation: Findagate Medical Centre, Brampton, Ontario, Canada.
authors.forename: Naresh
authors.initials: N
authors.lastname: Aggarwal
authors.affiliation: Pediatric and Adolescent Medicine, Nicholasville, Kentucky.
authors.forename: Michael
authors.initials: M
authors.lastname: Simon
authors.affiliation: Departments of Pediatrics and Medicine, Canadian Center for Vaccinology, Dalhousie University, Capital Health and the IWK Health Centre, Halifax, Nova Scotia, Canada.
authors.forename: Joanne M
authors.initials: JM
authors.lastname: Langley
authors.affiliation: Departments of Pediatrics and Medicine, Canadian Center for Vaccinology, Dalhousie University, Capital Health and the IWK Health Centre, Halifax, Nova Scotia, Canada.
authors.forename: Shelly A
authors.initials: SA
authors.lastname: McNeil
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Friedland
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: Veronique
authors.initials: V
authors.lastname: Bianco
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Carmen I
authors.initials: CI
authors.lastname: Baccarini
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Miller
keywords: Neisseria meningitidis; meningococcal conjugate vaccine; vaccine immunogenicity; vaccine safety