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An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015

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dc.creatorVichnin, Michellespa
dc.creatorBonanni, Paolospa
dc.creatorKlein, Nicola P.spa
dc.creatorGarland, Suzanne M.spa
dc.creatorBlock, Stan L.spa
dc.creatorKjaer, Susanne K.spa
dc.creatorSings, Heather L.spa
dc.creatorPerez, Gonzalospa
dc.creatorHaupt, Richard M.spa
dc.creatorSaah, Alfred J.spa
dc.creatorLievano, Fabiospa
dc.creatorVelicer, Christinespa
dc.creatorDrury, Rosybelspa
dc.creatorKuter, Barbara J.spa
dc.date.accessioned2020-05-25T23:57:57Z
dc.date.available2020-05-25T23:57:57Z
dc.date.created2015spa
dc.description.abstractBackground: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types 6/11/16/18. Across 7 phase 3 clinical trials involving more than 29,000 males and females ages 9-45 years, vaccination was generally well tolerated. Because of its expected public health benefit in reducing cervical cancer and other HPV-related diseases, the vaccine has been implemented in the national vaccination programs of several countries, with over 178 million doses distributed worldwide. Methods: Extensive efforts to assess the safety of the vaccine in routine practice have been conducted over the past 9 years since licensure, including more than 15 studies in more than 1 million preadolescents, adolescents and adults from various countries. Most have been performed in the general population although there have been some in special populations (pregnant women, HIV-infected individuals and those with systemic lupus erythematosus). Results: We present a summary of the published, postlicensure safety data from active and passive surveillance. Only syncope, and possibly skin infections were associated with vaccination in the postlicensure setting. Serious adverse events, such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates. Conclusions: These results, along with the safety data from the prelicensure clinical trials, confirm that the HPV4 vaccine has a favorable safety profile. Key policy, medical and regulatory organizations around the world have independently reviewed these data and continue to recommend routine HPV vaccination. Copyright © 2015 Wolters Kluwer Health, Inc.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1097/INF.0000000000000793
dc.identifier.issn8913668
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/22776
dc.language.isoengspa
dc.publisherLippincott Williams and Wilkinsspa
dc.relation.citationEndPage991
dc.relation.citationIssueNo. 9
dc.relation.citationStartPage983
dc.relation.citationTitlePediatric Infectious Disease Journal
dc.relation.citationVolumeVol. 34
dc.relation.ispartofPediatric Infectious Disease Journal, ISSN:8913668, Vol.34, No.9 (2015); pp. 983-991spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84940052308&doi=10.1097%2fINF.0000000000000793&partnerID=40&md5=a614a3b6c0b05d4537c827cde3717efdspa
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.keywordWart virus vaccinespa
dc.subject.keywordPostmarketingeng
dc.subject.keywordAnaphylaxisspa
dc.subject.keywordAnus cancerspa
dc.subject.keywordAutoimmune diseasespa
dc.subject.keywordCerebrovascular accidentspa
dc.subject.keywordClinical protocolspa
dc.subject.keywordClinical trial (topic)spa
dc.subject.keywordDrug safetyspa
dc.subject.keywordDrug surveillance programspa
dc.subject.keywordFaintnessspa
dc.subject.keywordGenital systemspa
dc.subject.keywordGuillain Barre syndromespa
dc.subject.keywordHumanspa
dc.subject.keywordHuman immunodeficiency virus infected patientspa
dc.subject.keywordIncidencespa
dc.subject.keywordLicensingspa
dc.subject.keywordPharmacoepidemiologyspa
dc.subject.keywordPrecancerspa
dc.subject.keywordPregnant womanspa
dc.subject.keywordPriority journalspa
dc.subject.keywordPublic healthspa
dc.subject.keywordReviewspa
dc.subject.keywordSkin infectionspa
dc.subject.keywordSystemic lupus erythematosusspa
dc.subject.keywordUterine cervix cancerspa
dc.subject.keywordVaccinationspa
dc.subject.keywordVagina cancerspa
dc.subject.keywordVenous thromboembolismspa
dc.subject.keywordVerruca vulgarisspa
dc.subject.keywordVulva cancerspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordChildspa
dc.subject.keywordDrug-Related Side Effects and Adverse Reactionsspa
dc.subject.keywordFemalespa
dc.subject.keywordMalespa
dc.subject.keywordMiddle agedspa
dc.subject.keywordPapillomavirus Infectionsspa
dc.subject.keywordPathologyspa
dc.subject.keywordPostmarketing surveillancespa
dc.subject.keywordPregnancyspa
dc.subject.keywordYoung adultspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordChildspa
dc.subject.keywordDrug-Related Side Effects and Adverse Reactionsspa
dc.subject.keywordFemalespa
dc.subject.keywordHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18spa
dc.subject.keywordHumansspa
dc.subject.keywordMalespa
dc.subject.keywordMiddle Agedspa
dc.subject.keywordPapillomavirus Infectionsspa
dc.subject.keywordPregnancyspa
dc.subject.keywordProduct Surveillanceeng
dc.subject.keywordYoung Adultspa
dc.subject.keywordGardasilspa
dc.subject.keywordHuman papillomavirusspa
dc.subject.keywordSafetyspa
dc.subject.keywordSurveillancespa
dc.subject.keywordVaccinespa
dc.titleAn Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015spa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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