/ Active, not recruitingPhase 3 评价重组三价人乳头瘤病毒(16/18/58 型)疫苗(大肠杆菌)在 9-26 岁中国健康女性中免疫原性和安全性的临床试验
[Translation] A clinical trial to evaluate the immunogenicity and safety of a recombinant trivalent human papillomavirus (type 16/18/58) vaccine (Escherichia coli) in healthy Chinese women aged 9-26 years
评价三价 HPV 试验疫苗在 9-14 岁(2 剂次)、9-17 岁(3 剂次)相比于 18-26 岁(3 剂次)中国女性中诱导免疫应答的非劣效性,并评
价其免疫应答持久性和安全性等。
[Translation] To evaluate the non-inferiority of the HPV trivalent vaccine in inducing immune responses in Chinese women aged 9-14 years (2 doses) and 9-17 years (3 doses) compared with those aged 18-26 years (3 doses), and to evaluate the durability and safety of the immune responses.
/ Active, not recruitingPhase 3 评价重组三价人乳头瘤病毒(16/18/58型)疫苗(大肠杆菌)在18-45岁中国女性的保护效力、安全性和免疫原性的多中心、随机、双盲、安慰剂对照的Ⅲ期临床试验
[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.
在18-45岁健康女性受试者中进行的重组三价人乳头瘤病毒(16/18/58型)疫苗(大肠杆菌)单中心I/II期临床试验(第二部分)
[Translation] A single-center phase I/II clinical trial of a recombinant trivalent human papillomavirus (type 16/18/58) vaccine (Escherichia coli) in healthy female subjects aged 18-45 years (Part II)
在中国18-45岁健康女性中,评价不同剂量的重组三价人乳头瘤病毒16/18/58型疫苗(大肠杆菌)的安全性、耐受性和免疫原性
[Translation] To evaluate the safety, tolerability, and immunogenicity of different doses of a recombinant trivalent human papillomavirus 16/18/58 vaccine (Escherichia coli) in healthy Chinese women aged 18-45 years
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