TY - JOUR
T1 - Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenaCyW-TT) administered concomitantly with other paediatric vaccines in toddlers
T2 - A Phase III randomized study
AU - Dhingra, M. S.
AU - Namazova-Baranova, L.
AU - Arredondo-Garcia, J. L.
AU - Kim, K. H.
AU - Limkittikul, K.
AU - Jantarabenjakul, W.
AU - Perminova, O.
AU - Kobashi, I. A.R.
AU - Bae, C. W.
AU - Ojeda, J.
AU - Park, J.
AU - Chansinghakul, D.
AU - B’Chir, S.
AU - Neveu, D.
AU - Bonaparte, M.
AU - Jordanov, E.
N1 - Publisher Copyright:
© The Author(s), 2021.
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Coadministration
KW - MenACYW-TT
KW - Paediatric vaccines
KW - Toddlers
UR - http://www.scopus.com/inward/record.url?scp=85103781676&partnerID=8YFLogxK
U2 - 10.1017/S0950268821000698
DO - 10.1017/S0950268821000698
M3 - Article
C2 - 33814028
AN - SCOPUS:85103781676
SN - 0950-2688
JO - Epidemiology and Infection
JF - Epidemiology and Infection
ER -