Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial
DC Field | Value | Language |
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dc.contributor.author | Han, Seung Beom | - |
dc.contributor.author | Rhim, Jung-Woo | - |
dc.contributor.author | Shin, Hye Jo | - |
dc.contributor.author | Lee, Soo Young | - |
dc.contributor.author | Kim, Hyun-Hee | - |
dc.contributor.author | Kim, Jong-Hyun | - |
dc.contributor.author | Lee, Kyung-Yil | - |
dc.contributor.author | Ma, Sang Hyuk | - |
dc.contributor.author | Park, Joon Soo | - |
dc.contributor.author | Kim, Hwang Min | - |
dc.contributor.author | Kim, Chun Soo | - |
dc.contributor.author | Kim, Dong Ho | - |
dc.contributor.author | Choi, Young Youn | - |
dc.contributor.author | Cha, Sung-Ho | - |
dc.contributor.author | Hong, Young Jin | - |
dc.contributor.author | Kang, Jin Han | - |
dc.date.accessioned | 2021-08-11T20:25:01Z | - |
dc.date.available | 2021-08-11T20:25:01Z | - |
dc.date.issued | 2015-05-04 | - |
dc.identifier.issn | 2164-5515 | - |
dc.identifier.issn | 2164-554X | - |
dc.identifier.uri | https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/10646 | - |
dc.description.abstract | A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8-67.2), 53.4% (95% CI: 48.1-58.7), and 54.9% (95% CI: 48.1-60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6-97.3), 93.8% (95% CI: 91.2-96.4), and 95.3% (95% CI: 93.0-97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective. | - |
dc.format.extent | 8 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Landes Bioscience | - |
dc.title | Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial | - |
dc.type | Article | - |
dc.publisher.location | 미국 | - |
dc.identifier.doi | 10.1080/21645515.2015.1017693 | - |
dc.identifier.scopusid | 2-s2.0-84942418597 | - |
dc.identifier.wosid | 000355117100016 | - |
dc.identifier.bibliographicCitation | Human Vaccines and Immunotherapeutics, v.11, no.5, pp 1094 - 1101 | - |
dc.citation.title | Human Vaccines and Immunotherapeutics | - |
dc.citation.volume | 11 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1094 | - |
dc.citation.endPage | 1101 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Biotechnology & Applied Microbiology | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalWebOfScienceCategory | Biotechnology & Applied Microbiology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.subject.keywordPlus | SEASONAL INFLUENZA | - |
dc.subject.keywordPlus | YOUNG-CHILDREN | - |
dc.subject.keywordPlus | OUTPATIENT VISITS | - |
dc.subject.keywordPlus | HOSPITALIZATIONS | - |
dc.subject.keywordPlus | VIRUS | - |
dc.subject.keywordPlus | AGE | - |
dc.subject.keywordPlus | REACTOGENICITY | - |
dc.subject.keywordPlus | SURVEILLANCE | - |
dc.subject.keywordPlus | IMMUNIZATION | - |
dc.subject.keywordPlus | COMMUNITY | - |
dc.subject.keywordAuthor | child | - |
dc.subject.keywordAuthor | clinical trial | - |
dc.subject.keywordAuthor | influenza | - |
dc.subject.keywordAuthor | Republic of Korea | - |
dc.subject.keywordAuthor | vaccine | - |
dc.subject.keywordAuthor | AE, adverse event | - |
dc.subject.keywordAuthor | CI, confidence interval | - |
dc.subject.keywordAuthor | FDA, Food and Drug Administration | - |
dc.subject.keywordAuthor | GMR, geometric mean titer ratio | - |
dc.subject.keywordAuthor | GMT, geometric mean titer | - |
dc.subject.keywordAuthor | HI, hemagglutination inhibition | - |
dc.subject.keywordAuthor | USA, United States of America | - |
dc.subject.keywordAuthor | WHO, World Health Organization | - |
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