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A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions

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dc.creatorKjaer, Susanne K.spa
dc.creatorSigurdsson, Kristjánspa
dc.creatorIversen, Ole-Erikspa
dc.creatorHernandez-Avila, Mauriciospa
dc.creatorWheeler, Cosette M.spa
dc.creatorPerez, Gonzalospa
dc.creatorBrown, Darron R.spa
dc.creatorKoutsky, Laura A.spa
dc.creatorTay, Eng Hseonspa
dc.creatorGarcía, Patriciaspa
dc.creatorAult, Kevin A.spa
dc.creatorGarland, Suzanne M.spa
dc.creatorLeodolter, Seppspa
dc.creatorOlsson, Sven-Ericspa
dc.creatorTang, Grace W.K.spa
dc.creatorFerris, Daron G.spa
dc.creatorPaavonen, Jormaspa
dc.creatorLehtinen, Mattispa
dc.creatorSteben, Marcspa
dc.creatorBosch, F. Xavierspa
dc.creatorDillner, Joakimspa
dc.creatorJoura, Elmar A.spa
dc.creatorMajewski, Slawomirspa
dc.creatorMuñoz, Nubiaspa
dc.creatorMyers, Evan R.spa
dc.creatorVilla, Luisa L.spa
dc.creatorTaddeo, Frank J.spa
dc.creatorRoberts, Christinespa
dc.creatorTadesse, Amhaspa
dc.creatorBryan, Janinespa
dc.creatorMaansson, Rogerspa
dc.creatorLu, Shuangspa
dc.creatorVuocolo, Scottspa
dc.creatorHesley, Teresa M.spa
dc.creatorSaah, Alfredspa
dc.creatorBarr, Eliavspa
dc.creatorHaupt, Richard M.spa
dc.date.accessioned2020-05-26T00:03:53Z
dc.date.available2020-05-26T00:03:53Z
dc.date.created2009spa
dc.description.abstractQuadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or ValN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination. ©2009 American Association for Cancer Research.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1158/1940-6207.CAPR-09-0031
dc.identifier.issn19406207
dc.identifier.issn19406215
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/23636
dc.language.isoengspa
dc.relation.citationEndPage878
dc.relation.citationIssueNo. 10
dc.relation.citationStartPage868
dc.relation.citationTitleCancer Prevention Research
dc.relation.citationVolumeVol. 2
dc.relation.ispartofCancer Prevention Research, ISSN:19406207, 19406215, Vol.2, No.10 (2009); pp. 868-878spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-70449338341&doi=10.1158%2f1940-6207.CAPR-09-0031&partnerID=40&md5=c96d66a682c94795c29c66c4b34f11d4spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.source.instnameinstname:Universidad del Rosariospa
dc.source.reponamereponame:Repositorio Institucional EdocURspa
dc.subject.keywordVirus DNAspa
dc.subject.keywordFemaleeng
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordAge distributionspa
dc.subject.keywordArticlespa
dc.subject.keywordCancer immunizationspa
dc.subject.keywordCancer preventionspa
dc.subject.keywordClinical trialspa
dc.subject.keywordControlled clinical trialspa
dc.subject.keywordControlled studyspa
dc.subject.keywordDrug efficacyspa
dc.subject.keywordDrug withdrawalspa
dc.subject.keywordFemalespa
dc.subject.keywordFollow upspa
dc.subject.keywordHumanspa
dc.subject.keywordHuman papillomavirus type 11spa
dc.subject.keywordHuman papillomavirus type 16spa
dc.subject.keywordHuman papillomavirus type 18spa
dc.subject.keywordHuman papillomavirus type 6spa
dc.subject.keywordMajor clinical studyspa
dc.subject.keywordMulticenter studyspa
dc.subject.keywordPapanicolaou testspa
dc.subject.keywordPhase 3 clinical trialspa
dc.subject.keywordPriority journalspa
dc.subject.keywordRandomized controlled trialspa
dc.subject.keywordSexual behaviorspa
dc.subject.keywordSmokingspa
dc.subject.keywordUnspecified side effectspa
dc.subject.keywordUterine cervix cancerspa
dc.subject.keywordVagina cancerspa
dc.subject.keywordVirus detectionspa
dc.subject.keywordVulva cancerspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordCancer Vaccinesspa
dc.subject.keywordCervical Intraepithelial Neoplasiaspa
dc.subject.keywordClinical Trialseng
dc.subject.keywordFemalespa
dc.subject.keywordGenital Diseaseseng
dc.subject.keywordHuman papillomavirus 11spa
dc.subject.keywordHuman papillomavirus 16spa
dc.subject.keywordHuman papillomavirus 18spa
dc.subject.keywordHuman papillomavirus 6spa
dc.subject.keywordHumansspa
dc.subject.keywordMulticenter Studies as Topicspa
dc.subject.keywordPapillomavirus Infectionsspa
dc.subject.keywordPapillomavirus Vaccinesspa
dc.subject.keywordRandomized Controlled Trials as Topicspa
dc.subject.keywordUterine Cervical Neoplasmsspa
dc.subject.keywordYoung Adultspa
dc.titleA pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesionsspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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