https://scholars.lib.ntu.edu.tw/handle/123456789/566437
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.author | LI-MIN HUANG | en_US |
dc.contributor.author | Chiu N.-C. | en_US |
dc.contributor.author | Yeh S.-J. | en_US |
dc.contributor.author | Bhusal C. | en_US |
dc.contributor.author | Arora A.K. | en_US |
dc.date.accessioned | 2021-06-24T07:16:32Z | - |
dc.date.available | 2021-06-24T07:16:32Z | - |
dc.date.issued | 2014 | - |
dc.identifier.issn | 0264-410X | - |
dc.identifier.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 | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/566437 | - |
dc.description.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. | - |
dc.publisher | Elsevier Ltd | - |
dc.relation.ispartof | Vaccine | - |
dc.subject | Adolescents; Children; Immunogenicity; Meningococcal disease; Quadrivalent conjugate vaccine; Safety | - |
dc.subject.classification | [SDGs]SDG3 | - |
dc.subject.other | 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 | - |
dc.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 | en_US |
dc.type | journal article | en |
dc.identifier.doi | 10.1016/j.vaccine.2014.07.063 | - |
dc.identifier.pmid | 25075804 | - |
dc.identifier.scopus | 2-s2.0-84906068521 | - |
dc.relation.pages | 5177-5184 | - |
dc.relation.journalvolume | 32 | - |
dc.relation.journalissue | 40 | - |
item.cerifentitytype | Publications | - |
item.fulltext | no fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_6501 | - |
item.openairetype | journal article | - |
item.grantfulltext | none | - |
crisitem.author.dept | Pediatrics | - |
crisitem.author.dept | Epidemiology and Preventive Medicine | - |
crisitem.author.dept | National Taiwan University Children's Hospital | - |
crisitem.author.dept | Pediatrics-NTUH | - |
crisitem.author.orcid | 0000-0002-9291-260X | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | College of Public Health | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
顯示於: | 醫學系 |
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