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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J. Ojeda, José Luis Arredondo-García, Kriengsak Limkittikul, Danaya Chansinghakul, K. H. Kim, Emilia Jordanov, J. Park, Matthew Bonaparte, W. Jantarabenjakul, O. Perminova, Mandeep S. Dhingra, Siham B’Chir, C. W. Bae, David Neveu, L. Namazova-Baranova, and I. A.R. Kobashi
- Subjects
Male ,Epidemiology ,paediatric vaccines ,Meningococcal Vaccines ,Neisseria meningitidis ,Antibodies, Viral ,Serogroup ,Measles ,Rubella ,complex mixtures ,Coadministration ,Pneumococcal conjugate vaccine ,Chickenpox Vaccine ,Pneumococcal Vaccines ,Immunogenicity, Vaccine ,Conjugate vaccine ,medicine ,Humans ,Hepatitis B Vaccines ,Vaccines, Combined ,toddlers ,Diphtheria-Tetanus-Pertussis Vaccine ,Haemophilus Vaccines ,Original Paper ,Tetanus ,business.industry ,Immunogenicity ,Diphtheria ,Toxoid ,Infant ,MenACYW-TT ,medicine.disease ,Antibodies, Bacterial ,Meningococcal Infections ,Poliovirus Vaccine, Inactivated ,Infectious Diseases ,Immunology ,Female ,Safety ,business ,Measles-Mumps-Rubella Vaccine ,medicine.drug - 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