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Safety and immunogenicity of a single dose of a quadrivalent meningococcal conjugate vaccine (MenACYW-D): a multicenter, blind-observer, randomized, phase III clinical trial in the Republic of Korea.

DC Field Value Language
dc.contributor.author김동수-
dc.contributor.author최준용-
dc.date.accessioned2017-02-24T11:13:59Z-
dc.date.available2017-02-24T11:13:59Z-
dc.date.issued2016-
dc.identifier.issn1201-9712-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/146701-
dc.description.abstractOBJECTIVES: To assess the safety and immunogenicity of a meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) in a Korean population. METHODS: This was a phase III, blind-observer, controlled study in which participants aged 11-55 years were randomized (2:1 ratio) to a single dose of MenACYW-D or tetanus/diphtheria/acellular pertussis (Tdap) vaccine. Outcomes included rates of seroconversion against all serogroups (≥4-fold increase in antibody titer from pre-vaccination), geometric mean titers (GMTs) at days 0 and 28 based on a serum bactericidal assay using baby rabbit complement, rates of seroprotection (titer ≥1:128) at day 28, and safety. RESULTS: A total of 300 participants were enrolled in the study (200 MenACYW-D and 100 Tdap). Seroconversion rates for serogroups A, C, Y, and W-135 were 77.8%, 88.3%, 74.6%, and 92.4%, respectively, for the MenACYW-D group and 9.3%, 8.1%, 12.2%, and 8.2%, respectively, for the Tdap group. The proportions of participants with pre-vaccination titers ≥1:128 were 57.3%, 12.6%, 51.5%, and 22.2% for serogroups A, C, Y, and W-135, respectively; post-vaccination rates were 98.5%, 89.4%, 96.0%, and 95.0% for the MenACYW-D group. A lower proportion of participants reported solicited reactions with MenACYW-D (46.2%) compared with Tdap (76.8%). CONCLUSION: A single dose of MenACYW-D was well tolerated and elicited a robust immune response in Korean adolescents and adults.-
dc.description.statementOfResponsibilityrestriction-
dc.format.extent59~64-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfINTERNATIONAL JOURNAL OF INFECTIOUS DISEASES-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdolescent-
dc.subject.MESHAdult-
dc.subject.MESHAntibodies, Bacterial/blood-
dc.subject.MESHChild-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMeningococcal Vaccines/adverse effects-
dc.subject.MESHMeningococcal Vaccines/immunology*-
dc.subject.MESHMiddle Aged-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHSeroconversion-
dc.subject.MESHSerogroup-
dc.subject.MESHVaccination-
dc.subject.MESHVaccines, Conjugate/immunology-
dc.subject.MESHYoung Adult-
dc.titleSafety and immunogenicity of a single dose of a quadrivalent meningococcal conjugate vaccine (MenACYW-D): a multicenter, blind-observer, randomized, phase III clinical trial in the Republic of Korea.-
dc.typeArticle-
dc.publisher.locationCanada-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Pediatrics-
dc.contributor.googleauthorDong Soo Kim-
dc.contributor.googleauthorMin Ja Kim-
dc.contributor.googleauthorSung-Ho Cha-
dc.contributor.googleauthorHwang Min Kim-
dc.contributor.googleauthorJong-Hyun Kim-
dc.contributor.googleauthorKwang Nam Kim-
dc.contributor.googleauthorJin-Soo Lee-
dc.contributor.googleauthorJun Yong Choi-
dc.contributor.googleauthorValerie Bosch Castells-
dc.contributor.googleauthorHee Soo Kim-
dc.contributor.googleauthorJoon Bang-
dc.contributor.googleauthorPhilipp Oster-
dc.identifier.doi10.1016/j.ijid.2016.02.010-
dc.contributor.localIdA00405-
dc.contributor.localIdA04191-
dc.relation.journalcodeJ01125-
dc.identifier.eissn1878-3511-
dc.identifier.pmid26921548-
dc.identifier.urlhttp://www.sciencedirect.com/science/article/pii/S1201971216000308-
dc.subject.keywordImmunogenicity-
dc.subject.keywordMenACYW–D-
dc.subject.keywordMeningococcal vaccine-
dc.subject.keywordRepublic of Korea-
dc.subject.keywordSafety-
dc.contributor.alternativeNameKim, Dong Soo-
dc.contributor.alternativeNameChoi, Jun Yong-
dc.contributor.affiliatedAuthorKim, Dong Soo-
dc.contributor.affiliatedAuthorChoi, Jun Yong-
dc.citation.volume45-
dc.citation.startPage59-
dc.citation.endPage64-
dc.identifier.bibliographicCitationINTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, Vol.45 : 59-64, 2016-
dc.date.modified2017-02-24-
dc.identifier.rimsid47446-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers

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