Cited 8 times in
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 |
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dc.contributor.author | 김동수 | - |
dc.contributor.author | 최준용 | - |
dc.date.accessioned | 2017-02-24T11:13:59Z | - |
dc.date.available | 2017-02-24T11:13:59Z | - |
dc.date.issued | 2016 | - |
dc.identifier.issn | 1201-9712 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/146701 | - |
dc.description.abstract | OBJECTIVES: 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.statementOfResponsibility | restriction | - |
dc.format.extent | 59~64 | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adolescent | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Antibodies, Bacterial/blood | - |
dc.subject.MESH | Child | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Meningococcal Vaccines/adverse effects | - |
dc.subject.MESH | Meningococcal Vaccines/immunology* | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Seroconversion | - |
dc.subject.MESH | Serogroup | - |
dc.subject.MESH | Vaccination | - |
dc.subject.MESH | Vaccines, Conjugate/immunology | - |
dc.subject.MESH | Young Adult | - |
dc.title | 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.type | Article | - |
dc.publisher.location | Canada | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Pediatrics | - |
dc.contributor.googleauthor | Dong Soo Kim | - |
dc.contributor.googleauthor | Min Ja Kim | - |
dc.contributor.googleauthor | Sung-Ho Cha | - |
dc.contributor.googleauthor | Hwang Min Kim | - |
dc.contributor.googleauthor | Jong-Hyun Kim | - |
dc.contributor.googleauthor | Kwang Nam Kim | - |
dc.contributor.googleauthor | Jin-Soo Lee | - |
dc.contributor.googleauthor | Jun Yong Choi | - |
dc.contributor.googleauthor | Valerie Bosch Castells | - |
dc.contributor.googleauthor | Hee Soo Kim | - |
dc.contributor.googleauthor | Joon Bang | - |
dc.contributor.googleauthor | Philipp Oster | - |
dc.identifier.doi | 10.1016/j.ijid.2016.02.010 | - |
dc.contributor.localId | A00405 | - |
dc.contributor.localId | A04191 | - |
dc.relation.journalcode | J01125 | - |
dc.identifier.eissn | 1878-3511 | - |
dc.identifier.pmid | 26921548 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S1201971216000308 | - |
dc.subject.keyword | Immunogenicity | - |
dc.subject.keyword | MenACYW–D | - |
dc.subject.keyword | Meningococcal vaccine | - |
dc.subject.keyword | Republic of Korea | - |
dc.subject.keyword | Safety | - |
dc.contributor.alternativeName | Kim, Dong Soo | - |
dc.contributor.alternativeName | Choi, Jun Yong | - |
dc.contributor.affiliatedAuthor | Kim, Dong Soo | - |
dc.contributor.affiliatedAuthor | Choi, Jun Yong | - |
dc.citation.volume | 45 | - |
dc.citation.startPage | 59 | - |
dc.citation.endPage | 64 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, Vol.45 : 59-64, 2016 | - |
dc.date.modified | 2017-02-24 | - |
dc.identifier.rimsid | 47446 | - |
dc.type.rims | ART | - |
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