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Women aged 18\u201325 years from Jiangsu province were randomized (1:1) to receive HPV vaccine (<jats:italic>n<\/jats:italic>\u2009=\u20093,026) or Al(OH)<jats:sub>3<\/jats:sub> control (<jats:italic>n<\/jats:italic>\u2009=\u20093,025) at months 0, 1 and 6. The primary objective was vaccine efficacy (VE) against HPV\u201016\/18 associated 6\u2010month persistent infection (PI) and\/or cervical intraepithelial neoplasia (CIN) 1+. Secondary objectives were VE against virological and clinical endpoints associated with HPV\u201016\/18 and with high\u2010risk HPV types, immunogenicity and safety. Mean follow\u2010up for the according\u2010to\u2010protocol cohort for efficacy (ATP\u2010E) was \u223c15 months after the third dose. In the ATP\u2010E (vaccine\u2009=\u20092,889; control\u2009=\u20092,894), for initially HPV DNA negative and seronegative subjects, HPV\u201016\/18 related VE (95% CI) was 94.2% (62.7, 99.9) against 6\u2010month PI and\/or CIN1+ and 93.8% (60.2, 99.9) against cytological abnormalities. VE against HPV\u201016\/18 associated CIN1+ and CIN2+ was 100% (\u221250.4, 100) and 100% (\u2212140.2, 100), respectively (no cases in the vaccine group and 4 CIN1+ and 3 CIN2+ cases in the control group). At Month 7, at least 99.7% of initially seronegative vaccine recipients had seroconverted for HPV\u201016\/18; geometric mean antibody titres (95% CI) were 6,996 (6,212 to 7,880) EU\/mL for anti\u2010HPV\u201016 and 3,309 (2,942 to 3,723) EU\/mL for anti\u2010HPV\u201018. Safety outcomes between groups were generally similar. The HPV\u201016\/18 AS04\u2010adjuvanted vaccine is effective, immunogenic and has a clinically acceptable safety profile in young Chinese women. Prophylactic HPV vaccination has the potential to substantially reduce the burden of cervical cancer in China.<\/jats:p>","DOI":"10.1002\/ijc.28897","type":"journal-article","created":{"date-parts":[[2014,4,17]],"date-time":"2014-04-17T09:29:05Z","timestamp":1397726945000},"page":"2612-2622","source":"Crossref","is-referenced-by-count":62,"title":["Efficacy, immunogenicity and safety of the HPV\u201016\/18 AS04\u2010adjuvanted vaccine in healthy Chinese women aged 18\u201325 years: Results from a randomized controlled trial"],"prefix":"10.1002","volume":"135","author":[{"given":"Feng\u2010Cai","family":"Zhu","sequence":"first","affiliation":[{"name":"Jiangsu Province Center for Disease Prevention and Control Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen","family":"Chen","sequence":"additional","affiliation":[{"name":"Cancer Institute and Hospital Chinese Academy of Medical Sciences (CICAMS) and Peking Union Medical College Beijing 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