[Translation] Multicenter, randomized, double-blind, placebo-controlled evaluation of the protection of quadrivalent recombinant human papillomavirus vaccine (Hansenula spp.) in Chinese women aged 18-45 against lower genital tract lesions associated with HPV6/11/16/18 infection Phase III clinical trials for efficacy, immunogenicity and safety
主要目的:评价四价重组人乳头瘤病毒(6/11/16/18型)疫苗(汉逊酵母)(以下简称“四价HPV疫苗”)接种于18-45岁中国女性预防HPV16/18型别感染相关的CIN2+宫颈病变的保护效力。
次要目的:1)评价四价HPV疫苗接种于18-45岁中国女性全程免疫30天后预防HPV6/11/16/18型别感染相关的12个月持续感染(12-month Persistent Infection, PI12保护效力;
2)评价四价HPV疫苗接种于18-45岁中国女性全程免疫30天后预防HPV6/11/16/18型别感染相关的6个月持续感染保护效力;
3)评价四价HPV疫苗接种于18-45岁中国女性全程免疫30天后预防HPV6/11/16/18型别感染相关的外生殖器和阴道病变(包括:生殖器疣、VIN1+、AIN1+和VaIN1+)的保护效力;
4)评价四价HPV疫苗接种于18-45岁中国女性的免疫原性;
5)评价四价HPV疫苗接种于18-45岁中国女性的安全性。
[Translation] Main purpose: To evaluate the prevention of HPV 16/18 in Chinese women aged 18-45 by quadrivalent recombinant human papillomavirus (6/11/16/18) vaccine (Hansenula yeast) (hereinafter referred to as "tetravalent HPV vaccine") Protective efficacy against infection-related CIN2+ cervical lesions.
Secondary objectives: 1) To evaluate the prevention of 12-month persistent infection (PI12) associated with HPV6/11/16/18 infection by quadrivalent HPV vaccination in Chinese women aged 18-45 years after full immunization for 30 days efficacy;
2) To evaluate the efficacy of quadrivalent HPV vaccine in the prevention of HPV6/11/16/18 type infection in 18-45-year-old Chinese women after 30 days of full immunization;
3) To evaluate the efficacy of quadrivalent HPV vaccination in preventing genital and vaginal lesions (including: genital warts, VIN1+, AIN1+ and VaIN1+) associated with HPV6/11/16/18 infection in Chinese women aged 18-45 years after 30 days of full immunization. protective effect;
4) To evaluate the immunogenicity of quadrivalent HPV vaccine in Chinese women aged 18-45;
5) To evaluate the safety of quadrivalent HPV vaccine in Chinese women aged 18-45.