title: Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study.
abstract: BACKGROUND
  MenACWY-CRM (Menveo®, Novartis Vaccines, Siena, Italy) is a quadrivalent meningococcal conjugate vaccine developed to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. It is approved within the European Union in persons >2 years of age and in persons from 2 months to 55 years of age in the United States, among other countries. Little is known about the immunogenicity and safety of this vaccine in Taiwanese children >2 years and adolescents. This study assessed the immunogenicity and safety of a single injection of MenACWY-CRM vaccine in Taiwanese subjects aged 2-18 years old.
  
  
  METHODS
  In this phase III, multicentre, open-label study 341 subjects received one dose of MenACWY-CRM. Immunogenicity measures were rates of seroresponse (defined as the proportion of subjects with a postvaccination hSBA ≥1:8 if the prevaccination (baseline) titre was <1:4, or at least a fourfold higher hSBA titre than baseline if the prevaccination titre was ≥1:4), percentages of subjects with serum bactericidal activity (hSBA) ≥1:8 for serogroups A, C, W and Y and hSBA geometric mean titres (GMTs). Local and systemic reactions and all adverse events (AEs) were recorded for 7 days, and medically attended AEs for 1 month post-vaccination.
  
  
  RESULTS
  Seroresponse rates after MenACWY-CRM vaccination at Day 29 for the serogroups A, C, W, and Y were 83%, 93%, 50%, and 65%, respectively. At Day 29 the percentages of subjects with hSBA ≥1:8 against all four serogroups A, C, W and Y were: 83%, 96%, 96% and 82%, respectively. GMTs against all serogroups rose by ≥7-fold from baseline to Day 29. The vaccine was well tolerated.
  
  
  CONCLUSIONS
  A single dose of MenACWY-CRM demonstrated a robust immune response, and an acceptable safety profile in Taiwanese children and adolescents.
authors: Department of Pediatrics, National Taiwan University Hospital, No. 8, Chung-Shan S. Rd., Taipei 10048, Taiwan.
authors: Li-Min
authors: LM
authors: Huang
authors: Department of Pediatrics, Mackay Memorial Hospital, No. 92, Sec. 2, Chung-Shan N. Rd., Taipei 10449, Taiwan.
authors: Nan-Chang
authors: NC
authors: Chiu
authors: Far Eastern Memorial Hospital, No. 21, Nan-Ya S. Rd., Sec. 2, Pan-Chiao, Taipei 22060, Taiwan.
authors: Shu-Jen
authors: SJ
authors: Yeh
authors: Novartis Vaccines and Diagnostics, Srl., Siena, Italy.
authors: Chiranjiwi
authors: C
authors: Bhusal
authors: Novartis Vaccines and Diagnostics, Srl., Siena, Italy. Electronic address: ashwani_kumar.arora@novartis.com.
authors: Ashwani Kumar
authors: AK
authors: Arora
mesh_terms: D000293:Adolescent; D001770:Blood Bactericidal Activity; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000627:therapeutic use*; D013624:Taiwan
chemical_list: C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines
keywords: Adolescents; Children; Immunogenicity; Meningococcal disease; Quadrivalent conjugate vaccine; Safety