Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study
- 주제(키워드) Coadministration , MenACYW-TT , paediatric vaccines , toddlers
- 주제(기타) Public, Environmental & Occupational Health
- 주제(기타) Infectious Diseases
- 설명문(일반) [Dhingra, M. S.; Jordanov, E.] Sanofi Pasteur, Global Clin Sci, Swiftwater, PA 18370 USA; [Namazova-Baranova, L.] Russian Acad Sci, Inst Pediat, Cent Clin Hosp, Moscow, Russia; [Arredondo-Garcia, J. L.] Inst Nacl Pediat, Clin Res Unit, Mexico City, DF, Mexico; [Kim, K. -H.] Ewha Womans Univ, Coll Med, Dept Pediat, Seoul, South Korea; [Limkittikul, K.] Mahidol Univ, Fac Trop Med, Bangkok, Thailand; [Jantarabenjakul, W.] Chulalongkorn Univ, Dept Pediat, Fac Med, Bangkok, Thailand; [Perminova, O.] City Children Clin Outpatient Hosp 5, Perm, Russia; [Kobashi, I. A. R.] Ctr Invest Clin Pacifico, Guerrero, Mexico; [Bae, C. -W.] Kyung Hee Univ Hosp Gangdong, Seoul, South Korea; [Ojeda, J.] Sanofi Pasteur, Global Clin Sci, Mexico City, DF, Mexico; [Park, J.] Sanofi Pasteur, Global Clin Sci, Singapore, Singapore; [Chansinghakul, D.] Sanofi Pasteur, Global Clin Sci, Bangkok, Thailand; [B'Chir, S.] Sanofi Pasteur, Global Biostat Sci, Marcy Letoile, France; [Neveu, D.] Sanofi Pasteur, Global Pharmacovigilance, Swiftwater, PA USA; [Bonaparte, M.] Sanofi Pasteur, Global Clin Immunol, Swiftwater, PA USA
- 등재 SCIE, SCOPUS
- 발행기관 CAMBRIDGE UNIV PRESS
- 발행년도 2021
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000181560
- 본문언어 영어
- Published As http://dx.doi.org/10.1017/S0950268821000698
초록/요약
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.
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