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Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial
dc.audience | Comunidad Rosarista | spa |
dc.creator | Dillner, Joakim | |
dc.creator | Kjær, Susanne Krüger | |
dc.creator.google | Dillner, Joakim | |
dc.creator.google | Kjær, Susanne Krüger | |
dc.date.accessioned | 2014-08-12T14:10:27Z | |
dc.date.available | 2014-08-12T14:10:27Z | |
dc.date.created | 2010 | |
dc.date.issued | 2010 | |
dc.description.abstract | Objectives: To evaluate the prophylactic efficacy of the human papillomavirus (HPV) quadrivalent vaccine in preventing low grade cervical, vulvar, and vaginal intraepithelial neoplasias and anogenital warts (condyloma acuminata). Design: Data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). The trials were to be 4 years in length, and the results reported are from final study data of 42 months' follow-up. Setting: Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants: 17 622 women aged 16-26 years enrolled between December 2001 and May 2003. Major exclusion criteria were lifetime number of sexual partners (>4), history of abnormal cervical smear test results, and pregnancy. Intervention: Three doses of quadrivalent HPV vaccine (for serotypes 6, 11, 16, and 18) or placebo at day 1, month 2, and month 6. Main outcome measures: Vaccine efficacy against cervical, vulvar, and vaginal intraepithelial neoplasia grade I and condyloma in a per protocol susceptible population that included subjects who received all three vaccine doses, tested negative for the relevant vaccine HPV types at day 1 and remained negative through month 7, and had no major protocol violations. Intention to treat, generally HPV naive, and unrestricted susceptible populations were also studied. Results: In the per protocol susceptible population, vaccine efficacy against lesions related to the HPV types in the vaccine was 96% for cervical intraepithelial neoplasia grade I (95% confidence interval 91% to 98%), 100% for both vulvar and vaginal intraepithelial neoplasia grade I (95% CIs 74% to 100%, 64% to 100% respectively), and 99% for condyloma (96% to 100%). Vaccine efficacy against any lesion (regardless of HPV type) in the generally naive population was 30% (17% to 41%), 75% (22% to 94%), and 48% (10% to 71%) for cervical, vulvar, and vaginal intraepithelial neoplasia grade I, respectively, and 83% (74% to 89%) for condyloma. Conclusions: Quadrivalent HPV vaccine provided sustained protection against low grade lesions attributable to vaccine HPV types (6, 11, 16, and 18) and a substantial reduction in the burden of these diseases through 42 months of follow-up. Trial registrations: NCT00092521 and NCT00092534. | eng |
dc.format.medium | Recurso electrónico | spa |
dc.format.mimetype | application/pdf | |
dc.format.tipo | Documento | spa |
dc.identifier.issn | ISSN:17561833 | |
dc.identifier.uri | http://repository.urosario.edu.co/handle/10336/8803 | |
dc.language.iso | eng | |
dc.publisher | Universidad del Rosario | spa |
dc.relation.citationTitle | BMJ | |
dc.relation.ispartof | BMJ (Online) ISSN: 17561833 | spa |
dc.relation.uri | http://www.bmj.com.ez.urosario.edu.co/highwire/filestream/382653/field_highwire_article_pdf/0/bmj.c3493 | |
dc.rights.accesRights | info:eu-repo/semantics/openAccess | |
dc.rights.acceso | Abierto (Texto completo) | spa |
dc.rights.licencia | EL AUTOR, manifiesta que la obra objeto de la presente autorización es original y la realizó sin violar o usurpar derechos de autor de terceros, por lo tanto la obra es de exclusiva autoría y tiene la titularidad sobre la misma. | spa |
dc.source.instname | instname:Universidad del Rosario | spa |
dc.source.reponame | reponame:Repositorio Institucional EdocUR | spa |
dc.subject.ddc | Ginecología & otras especialidades médicas | |
dc.subject.decs | Virus del papiloma humano. VPH | spa |
dc.subject.decs | Vacunas | spa |
dc.subject.decs | Enfermedades infecciosas | spa |
dc.subject.decs | Vacuna cuadrivalente | spa |
dc.subject.decs | Neoplasmas | spa |
dc.title | Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial | spa |
dc.type | article | eng |
dc.type.hasVersion | info:eu-repo/semantics/acceptedVersion | |
dc.type.spa | Artículo | spa |
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