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Four year efficacy ...
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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- Dillner, Joakim (author)
- Karolinska Institutet,Lund University,Lunds universitet,Klinisk mikrobiologi, Malmö,Forskargrupper vid Lunds universitet,Clinical Microbiology, Malmö,Lund University Research Groups
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Kjaer, Susanne K (author)
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Wheeler, Cosette M (author)
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Sigurdsson, Kristján (author)
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Iversen, Ole-Erik (author)
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Hernandez-Avila, Mauricio (author)
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Perez, Gonzalo (author)
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Brown, Darron R (author)
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Koutsky, Laura A (author)
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Tay, Eng Hseon (author)
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García, Patricia (author)
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Ault, Kevin A (author)
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Garland, Suzanne M (author)
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Leodolter, Sepp (author)
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- Olsson, Sven-Eric (author)
- Karolinska Institutet
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Tang, Grace W K (author)
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Ferris, Daron G (author)
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Paavonen, Jorma (author)
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Lehtinen, Matti (author)
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Steben, Marc (author)
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Bosch, F Xavier (author)
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Joura, Elmar A (author)
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Majewski, Slawomir (author)
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Muñoz, Nubia (author)
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Myers, Evan R (author)
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Villa, Luisa L (author)
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Taddeo, Frank J (author)
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Roberts, Christine (author)
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Tadesse, Amha (author)
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Bryan, Janine T (author)
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Maansson, Roger (author)
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Lu, Shuang (author)
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Vuocolo, Scott (author)
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Hesley, Teresa M (author)
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Barr, Eliav (author)
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Haupt, Richard (author)
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(creator_code:org_t)
- 2010-07-20
- 2010
- English.
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In: BMJ: British Medical Journal. - : BMJ. - 1756-1833 .- 0959-8138 .- 1468-5833. ; 341
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Mikrobiologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Microbiology in the medical area (hsv//eng)
Keyword
- Vaginal Neoplasms: prevention & control
- Uterine Cervical Neoplasms: prevention & control
- Urogenital Neoplasms: prevention & control
- Papillomavirus Infections: prevention & control
- Condylomata Acuminata: prevention & control
- Carcinoma in Situ: prevention & control
- Cervical Intraepithelial Neoplasia: prevention & control
- Vulvar Neoplasms: prevention & control
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Dillner, Joakim
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Kjaer, Susanne K
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Wheeler, Cosette ...
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Sigurdsson, Kris ...
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Iversen, Ole-Eri ...
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Hernandez-Avila, ...
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show more...
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Perez, Gonzalo
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Brown, Darron R
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Koutsky, Laura A
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Tay, Eng Hseon
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García, Patricia
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Ault, Kevin A
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Garland, Suzanne ...
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Leodolter, Sepp
-
Olsson, Sven-Eri ...
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Tang, Grace W K
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Ferris, Daron G
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Paavonen, Jorma
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Lehtinen, Matti
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Steben, Marc
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Bosch, F Xavier
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Joura, Elmar A
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Majewski, Slawom ...
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Muñoz, Nubia
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Myers, Evan R
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Villa, Luisa L
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Taddeo, Frank J
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Roberts, Christi ...
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Tadesse, Amha
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Bryan, Janine T
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Maansson, Roger
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Lu, Shuang
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Vuocolo, Scott
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Hesley, Teresa M
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Barr, Eliav
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Haupt, Richard
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Microbiology in ...
- Articles in the publication
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BMJ: British Med ...
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BMJ
- By the university
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Lund University
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Karolinska Institutet