1. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study.
- Author
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Dhingra MS, Namazova-Baranova L, Arredondo-Garcia JL, Kim KH, Limkittikul K, Jantarabenjakul W, Perminova O, Kobashi IAR, Bae CW, Ojeda J, Park J, Chansinghakul D, B'Chir S, Neveu D, Bonaparte M, and Jordanov E
- Subjects
- 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, 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, Meningococcal Infections prevention & control, Meningococcal Vaccines immunology, Neisseria meningitidis immunology
- 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.
- Published
- 2021
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