Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial.

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Fältnamn	Indikatorer	Metadata
000		06408naa a2200901 4500
001		oai:lup.lub.lu.se:093e1a6c-880e-45a9-947d-9596e2730fa2
003		SwePub
008		160404s2010 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
009		oai:prod.swepub.kib.ki.se:121044802
024	7	a https://lup.lub.lu.se/record/16446642 URI
024	7	a https://doi.org/10.1136/bmj.c34932 DOI
024	7	a http://kipublications.ki.se/Default.aspx?queryparsed=id:1210448022 URI
040		a (SwePub)lud (SwePub)ki
041		a engb eng
042		9 SwePub
072	7	a art2 swepub-publicationtype
072	7	a ref2 swepub-contenttype
100	1	a Dillner, Joakimu Karolinska Institutet,Lund University,Lunds universitet,Klinisk mikrobiologi, Malmö,Forskargrupper vid Lunds universitet,Clinical Microbiology, Malmö,Lund University Research Groups4 aut0 (Swepub:lu)mikr-jdi
245	1 0	a Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial.
264		c 2010-07-20
264	1	b BMJ,c 2010
338		a electronic2 rdacarrier
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Mikrobiologi inom det medicinska området0 (SwePub)301092 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Microbiology in the medical area0 (SwePub)301092 hsv//eng
653		a Vaginal Neoplasms: prevention & control
653		a Uterine Cervical Neoplasms: prevention & control
653		a Urogenital Neoplasms: prevention & control
653		a Papillomavirus Infections: prevention & control
653		a Condylomata Acuminata: prevention & control
653		a Carcinoma in Situ: prevention & control
653		a Cervical Intraepithelial Neoplasia: prevention & control
653		a Vulvar Neoplasms: prevention & control
700	1	a Kjaer, Susanne K4 aut
700	1	a Wheeler, Cosette M4 aut
700	1	a Sigurdsson, Kristján4 aut
700	1	a Iversen, Ole-Erik4 aut
700	1	a Hernandez-Avila, Mauricio4 aut
700	1	a Perez, Gonzalo4 aut
700	1	a Brown, Darron R4 aut
700	1	a Koutsky, Laura A4 aut
700	1	a Tay, Eng Hseon4 aut
700	1	a García, Patricia4 aut
700	1	a Ault, Kevin A4 aut
700	1	a Garland, Suzanne M4 aut
700	1	a Leodolter, Sepp4 aut
700	1	a Olsson, Sven-Ericu Karolinska Institutet4 aut
700	1	a Tang, Grace W K4 aut
700	1	a Ferris, Daron G4 aut
700	1	a Paavonen, Jorma4 aut
700	1	a Lehtinen, Matti4 aut
700	1	a Steben, Marc4 aut
700	1	a Bosch, F Xavier4 aut
700	1	a Joura, Elmar A4 aut
700	1	a Majewski, Slawomir4 aut
700	1	a Muñoz, Nubia4 aut
700	1	a Myers, Evan R4 aut
700	1	a Villa, Luisa L4 aut
700	1	a Taddeo, Frank J4 aut
700	1	a Roberts, Christine4 aut
700	1	a Tadesse, Amha4 aut
700	1	a Bryan, Janine T4 aut
700	1	a Maansson, Roger4 aut
700	1	a Lu, Shuang4 aut
700	1	a Vuocolo, Scott4 aut
700	1	a Hesley, Teresa M4 aut
700	1	a Barr, Eliav4 aut
700	1	a Haupt, Richard4 aut
710	2	a Klinisk mikrobiologi, Malmöb Forskargrupper vid Lunds universitet4 org
773	0	t BMJ: British Medical Journald : BMJg 341q 341x 1756-1833x 0959-8138x 1468-5833
773	0	t BMJd : BMJg 341q 341x 0959-8138x 1468-5833
856	4	u https://portal.research.lu.se/files/5364347/1660582.pdfx primaryx freey FULLTEXT
856	4	u http://www.ncbi.nlm.nih.gov/pubmed/20647284?dopt=Abstracty FULLTEXT
856	4	u http://dx.doi.org/10.1136/bmj.c3493y FULLTEXT
856	4	u https://www.bmj.com/content/341/bmj.c3493.full.pdf
856	4 8	u https://lup.lub.lu.se/record/1644664
856	4 8	u https://doi.org/10.1136/bmj.c3493
856	4 8	u http://kipublications.ki.se/Default.aspx?queryparsed=id:121044802

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