Invasive meningococcal disease (IMD) has high morbidity and mortality, with infants and young children among those at greatest risk. This phase III, open-label, randomized study in toddlers aged 12-23 months evaluated the immunogenicity and safety of 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 upto 30 days post-vaccination. A total of 1,183 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.
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© The Author(s), 2021.
- Paediatric vaccines