https://scholars.lib.ntu.edu.tw/handle/123456789/566437
Title: | Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: Results of an open label study | Authors: | LI-MIN HUANG Chiu N.-C. Yeh S.-J. Bhusal C. Arora A.K. |
Keywords: | Adolescents; Children; Immunogenicity; Meningococcal disease; Quadrivalent conjugate vaccine; Safety | Issue Date: | 2014 | Publisher: | Elsevier Ltd | Journal Volume: | 32 | Journal Issue: | 40 | Start page/Pages: | 5177-5184 | Source: | Vaccine | Abstract: | MenACWY-CRM (Menveo?, Novartis Vaccines, Siena, Italy) is a quadrivalent meningococcal conjugate vaccine developed to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. It is approved within the European Union in persons >2 years of age and in persons from 2 months to 55 years of age in the United States, among other countries. Little is known about the immunogenicity and safety of this vaccine in Taiwanese children >2 years and adolescents. This study assessed the immunogenicity and safety of a single injection of MenACWY-CRM vaccine in Taiwanese subjects aged 2-18 years old. Methods: In this phase III, multicentre, open-label study 341 subjects received one dose of MenACWY-CRM. Immunogenicity measures were rates of seroresponse (defined as the proportion of subjects with a postvaccination hSBA ?1:8 if the prevaccination (baseline) titre was <1:4, or at least a fourfold higher hSBA titre than baseline if the prevaccination titre was ?1:4), percentages of subjects with serum bactericidal activity (hSBA) ?1:8 for serogroups A, C, W and Y and hSBA geometric mean titres (GMTs). Local and systemic reactions and all adverse events (AEs) were recorded for 7 days, and medically attended AEs for 1 month post-vaccination. Results: Seroresponse rates after MenACWY-CRM vaccination at Day 29 for the serogroups A, C, W, and Y were 83%, 93%, 50%, and 65%, respectively. At Day 29 the percentages of subjects with hSBA ?1:8 against all four serogroups A, C, W and Y were: 83%, 96%, 96% and 82%, respectively. GMTs against all serogroups rose by ?7-fold from baseline to Day 29. The vaccine was well tolerated. Conclusions: A single dose of MenACWY-CRM demonstrated a robust immune response, and an acceptable safety profile in Taiwanese children and adolescents. ? 2014 Elsevier Ltd. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84906068521&doi=10.1016%2fj.vaccine.2014.07.063&partnerID=40&md5=36f258314827e3c0dad104829d607a7c https://scholars.lib.ntu.edu.tw/handle/123456789/566437 |
ISSN: | 0264-410X | DOI: | 10.1016/j.vaccine.2014.07.063 | SDG/Keyword: | Meningococcus vaccine; MenACWY-CRM vaccine; Meningococcus vaccine; adolescent; adult; antibody titer; arthralgia; article; child; chill; diarrhea; dizziness; drug eruption; drug safety; drug tolerability; erythema; female; fever; groups by age; headache; human; immune response; immunogenicity; injection site erythema; injection site induration; injection site pruritus; irritability; malaise; male; multicenter study; myalgia; nausea; normal human; open study; pain; phase 3 clinical trial; pneumonia; priority journal; rhinopharyngitis; serum bactericidal activity; side effect; single drug dose; somnolence; Taiwan; treatment response; upper respiratory tract infection; urticaria; vaccination; vomiting; clinical trial; Meningococcal Infections; preschool child; Adolescent; Blood Bactericidal Activity; Child; Child, Preschool; Female; Humans; Male; Meningococcal Infections; Meningococcal Vaccines; Taiwan |
Appears in Collections: | 醫學系 |
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