A Phase III Multicenter, Randomized, Double-Blind, Placebo(Hepatitis E Vaccine)Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant(E.Coli)Human Papillomavirus Bivalent Vaccine in Healthy Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7,372
- 试验地点
- 2
- 主要终点
- Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection
研究概览
简要总结
This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects between, and including, 18 and 45 years of age at the first vaccination;
- •Healthy subjects as established by medical history and history-oriented clinical examination;
- •Be able to understand and comply with the request of the protocol;
- •Without acute cervicitis;
- •Not pregnant;
- •Have intact cervix.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period;
- •Are using immunosuppressants;
- •Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period;
- •Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment;
- •Concurrently participating another clinical trial;
- •Has received vaccines against HPV 16/18 ;
- •Immunodeficient;
- •History of allergic disease;
- •Serious medical disorders;
- •Blood coagulation disorders;
- •Unable to comply with protocol due to the mental illness;
- •Visible Condyloma;
- •Pregnant or breast-feeding women;
- •Have more than 4 sexual partners.
结局指标
主要结局
Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection
时间窗: expected 5-6 years
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)
时间窗: expected 2-3 years
次要结局
- Number of Subjects Reporting Unsolicited Adverse Events(Month 7)
- number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18(expected 5-6 years)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(expected 5-6 years)
- Number of Subjects Reporting Solicited Local and General Symptoms(Within 7 days after each vaccination)
- number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection(expected 5-6 years)
- number of subjects with incidence infection associated with HPV-16 and/or HPV-18(expected 2-3 years)
- Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7(month 7)
研究者
Jun Zhang
professor
Xiamen University