[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the protective efficacy, safety and immunogenicity of a recombinant trivalent human papillomavirus (type 16/18/58) vaccine (Escherichia coli) in Chinese women aged 18-45 years
评价重组三价 HPV 疫苗(16/18/58 型)接种于 18-45 岁中国女性人群的保护效力。在 18-45 岁女性中接种三剂重组三价 HPV 疫苗(16/18/58 型)后可有效预防 HPV16、18 和 58 型别感染相关的高度宫颈异常(CIN 2/3)、原位腺癌(AIS)、浸润性宫颈癌、高级外阴上皮内瘤样病变(VIN 2/3)、高级阴道上皮内瘤样病变(VaIN 2/3)、外阴癌或阴道癌病变的发生。在 18-45 岁女性中接种三剂重组三价 HPV 疫苗(16/18/58 型)后可有效预防 HPV16、18 和 58 型别相关的 12 个月持续感染(PI12)。
[Translation] To evaluate the protective efficacy of recombinant trivalent HPV vaccine (type 16/18/58) in Chinese females aged 18-45 years. Three doses of recombinant trivalent HPV vaccine (type 16/18/58) in females aged 18-45 years can effectively prevent the occurrence of high-grade cervical abnormalities (CIN 2/3), adenocarcinoma in situ (AIS), invasive cervical cancer, high-grade vulvar intraepithelial neoplasia (VIN 2/3), high-grade vaginal intraepithelial neoplasia (VaIN 2/3), vulvar cancer or vaginal cancer lesions associated with HPV16, 18 and 58 infection. Three doses of recombinant trivalent HPV vaccine (type 16/18/58) in females aged 18-45 years can effectively prevent 12-month persistent infection (PI12) associated with HPV16, 18 and 58.