Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study

Epidemiol Infect. 2021 Apr 5:149:e90. doi: 10.1017/S0950268821000698.

Abstract

Invasive meningococcal disease has high morbidity and mortality, with infants and young children among those at greatest risk. This phase III, open-label, randomised study in toddlers aged 12-23 months evaluated the immunogenicity and safety of meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT), a tetanus toxoid conjugated vaccine against meningococcal serogroups A, C, W and Y, when coadministered with paediatric vaccines (measles, mumps and rubella [MMR]; varicella [V]; 6-in-1 combination vaccine against diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b [DTaP-IPV-HepB-Hib] and pneumococcal conjugate vaccine [PCV13])(NCT03205371). Immunogenicity to each meningococcal serogroup was assessed by serum bactericidal antibody assay using human complement (hSBA). Vaccine safety profiles were described up to 30 days post-vaccination. A total of 1183 participants were enrolled. The proportion with seroprotection (hSBA ≥1:8) to each meningococcal serogroup at Day 30 was comparable between the MenACYW-TT and MenACYW-TT + MMR + V groups (≥92 and ≥96%, respectively), between the MenACYW-TT and MenACYW-TT + DTaP-IPV-HepB-Hib groups (≥90% for both) and between the MenACYW-TT and MenACYW-TT + PCV13 groups (≥91 and ≥84%, respectively). The safety profiles of MenACYW-TT, and MMR + V, DTaP-IPV-HepB-Hib, and PCV13, with or without MenACYW-TT, were generally comparable. Coadministration of MenACYW-TT with paediatric vaccines in toddlers had no clinically relevant effect on the immunogenicity and safety of any of the vaccines.

Keywords: Coadministration; MenACYW-TT; paediatric vaccines; toddlers.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / blood
  • Antibodies, Viral / blood
  • Chickenpox Vaccine / administration & dosage
  • Chickenpox Vaccine / immunology
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
  • Diphtheria-Tetanus-Pertussis Vaccine / immunology
  • Female
  • Haemophilus Vaccines / administration & dosage
  • Haemophilus Vaccines / immunology
  • Hepatitis B Vaccines / administration & dosage
  • Hepatitis B Vaccines / immunology
  • Humans
  • Immunogenicity, Vaccine
  • Infant
  • Male
  • Measles-Mumps-Rubella Vaccine / administration & dosage
  • Measles-Mumps-Rubella Vaccine / immunology
  • Meningococcal Infections / prevention & control*
  • Meningococcal Vaccines / immunology*
  • Neisseria meningitidis / immunology*
  • Pneumococcal Vaccines / administration & dosage
  • Pneumococcal Vaccines / immunology
  • Poliovirus Vaccine, Inactivated / administration & dosage
  • Poliovirus Vaccine, Inactivated / immunology
  • Safety
  • Serogroup
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / immunology

Substances

  • 13-valent pneumococcal vaccine
  • Antibodies, Bacterial
  • Antibodies, Viral
  • Chickenpox Vaccine
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Haemophilus Vaccines
  • Hepatitis B Vaccines
  • Measles-Mumps-Rubella Vaccine
  • Meningococcal Vaccines
  • Pneumococcal Vaccines
  • Poliovirus Vaccine, Inactivated
  • Vaccines, Combined
  • diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
  • tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine

Associated data

  • ClinicalTrials.gov/NCT03205371