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Immunogenicity and Safety of a 9-Valent HPV Vaccine

DC FieldValueLanguage
dc.contributor.author김동수-
dc.date.accessioned2016-02-04T11:29:43Z-
dc.date.available2016-02-04T11:29:43Z-
dc.date.issued2015-
dc.identifier.issn0031-4005-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/140551-
dc.description.abstractOBJECTIVES: Prophylactic vaccination of youngwomen aged 16 to 26 years with the 9-valent (6/11/16/18/31/33/45/52/58) human papillomavirus (HPV) virus-like particle (9vHPV) vaccine prevents infection and disease. We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged 9 to 15 years. METHODS: Subjects (N = 3066) received a 3-dose regimen of 9vHPV vaccine administered at day 1, month 2, and month 6. Anti-HPV serologic assays were performed at day 1 and month 7. Noninferiority required that the lower bound of 2-sided 95% confidence intervals of geometric mean titer ratios (boys:young women or girls:young women) be >0.67 for each HPV type. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored. RESULTS: At 4 weeks after dose 3, >99% of girls, boys, and young women seroconverted for each vaccine HPV type. Increases in geometric mean titers to HPV types 6/11/16/18/31/33/45/52/58 were elicited in all vaccine groups. Responses in girls and boys were noninferior to those of young women. Persistence of anti-HPV responses was demonstrated through 2.5 years after dose 3. Administration of the 9vHPV vaccine was generally well tolerated. A lower proportion of girls (81.9%) and boys (72.8%) than young women (85.4%) reported injection-site AEs, most of which were mild to moderate in intensity. CONCLUSIONS: These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementing gender-neutral HPV vaccination programs in preadolescents and adolescents.-
dc.description.statementOfResponsibilityopen-
dc.format.extente28~e39-
dc.relation.isPartOfPediatrics-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleImmunogenicity and Safety of a 9-Valent HPV Vaccine-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Pediatrics (소아과학)-
dc.contributor.googleauthorPierre Van Damme-
dc.contributor.googleauthorSven Eric Olsson-
dc.contributor.googleauthorStanley Block-
dc.contributor.googleauthorXavier Castellsague-
dc.contributor.googleauthorGlenda E. Gray-
dc.contributor.googleauthorTeobaldo Herrera-
dc.contributor.googleauthorLi-Min Huang-
dc.contributor.googleauthorDong Soo Kim-
dc.contributor.googleauthorPunnee Pitisuttithum-
dc.contributor.googleauthorJoshua Chen-
dc.contributor.googleauthorSusan Christiano-
dc.contributor.googleauthorRoger Maansson-
dc.contributor.googleauthorErin Moeller-
dc.contributor.googleauthorXiao Sun-
dc.contributor.googleauthorScott Vuocolo-
dc.contributor.googleauthorAlain Luxembourg-
dc.identifier.doi10.1542/peds.2014-3745-
dc.admin.authorfalse-
dc.admin.mappingfalse-
dc.contributor.localIdA00405-
dc.relation.journalcodeJ02496-
dc.identifier.urlhttp://pediatrics.aappublications.org/content/136/1/e28.long-
dc.contributor.alternativeNameKim, Dong Soo-
dc.contributor.affiliatedAuthorKim, Dong Soo-
dc.rights.accessRightsnot free-
dc.citation.volume136-
dc.citation.number1-
dc.citation.startPage28-
dc.citation.endPage39-
dc.identifier.bibliographicCitationPediatrics, Vol.136(1) : 28-39, 2015-
dc.description.scptc63-
dc.date.scptcdate2019-01-04-
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실)

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