{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T07:15:33Z","timestamp":1767856533679,"version":"3.49.0"},"reference-count":32,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2013,4]]},"abstract":"A randomized double\u2010blind placebo\u2010controlled phase II<\/jats:styled-content> trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV<\/jats:styled-content>) types most frequently associated with cervical cancer (types 16\/18) and genital warts (types 6\/11) in J<\/jats:styled-content>apanese women aged 18\u201326\u00a0years. Participants were randomly assigned to either quadrivalent HPV<\/jats:styled-content> (types 6\/11\/16\/18) L<\/jats:styled-content>1 virus\u2010like particle vaccine (GARDASIL<\/jats:styled-content>) (n\u00a0<\/jats:italic>=\u00a0<\/jats:italic>509) or placebo (n\u00a0<\/jats:italic>=\u00a0<\/jats:italic>512). Participants underwent regular gynecological examinations, cervicovaginal sampling for HPV DNA<\/jats:styled-content>, testing for serum neutralizing antibodies to HPV<\/jats:styled-content> and P<\/jats:styled-content>apanicolau testing. The primary end\u2010point was the combined incidence of persistent infection with HPV<\/jats:styled-content> types 6, 11, 16 or 18 and cervical or external genital disease (i.e. cervical intraepithelial neoplasia, cervical cancer or external genital lesions related to HPV<\/jats:styled-content> 6, 11, 16 or 18. Primary analyses were done per protocol. Combined incidence of persistent infection or disease with HPV<\/jats:styled-content> 6, 11, 16 or 18 fell by 87.6% (95% confidence interval [CI<\/jats:styled-content>], 59.2\u201397.6; P<\/jats:italic>\u00a0<\u00a00.001), with HPV<\/jats:styled-content> 6 or 11 by 73.1% (95% CI<\/jats:styled-content>, \u22121.1\u201397.3; P<\/jats:italic>\u00a0=\u00a00.0756) and with HPV<\/jats:styled-content> 16 or 18 by 94.5% (95% CI<\/jats:styled-content>, 65.2\u201399.9; P<\/jats:italic>\u00a0<\u00a00.001) in those assigned vaccine compared with those assigned placebo. The median duration of follow up after month 7 in subjects was 23\u00a0months. In addition, the vaccine was well tolerated in J<\/jats:styled-content>apanese women aged 18\u201326\u00a0years. Quadrivalent HPV<\/jats:styled-content> vaccine could significantly reduce the acquisition of infection and clinical disease caused by HPV<\/jats:styled-content> types 6, 11, 16 and 18.<\/jats:p>","DOI":"10.1111\/cas.12106","type":"journal-article","created":{"date-parts":[[2013,1,17]],"date-time":"2013-01-17T16:31:05Z","timestamp":1358440265000},"page":"465-472","source":"Crossref","is-referenced-by-count":38,"title":["Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL<\/scp>) in J<\/scp>apanese women aged 18\u201326\u00a0years"],"prefix":"10.1111","volume":"104","author":[{"given":"Hiroyuki","family":"Yoshikawa","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology Faculty of Medicine University of Tsukuba Tsukuba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keiko","family":"Ebihara","sequence":"additional","affiliation":[{"name":"MSD K.K. 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