NCT03676101已完成1 期
A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Unsolicited Adverse Events
研究概览
简要总结
To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females between, and including, 9 and 45 years of age at the time of enrolment
- •Be able to provide legal identification for the sake of recruitment
- •Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together
- •Subjects who the investigator believes that they can and will comply with the protocol requirements
- •Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan
排除标准
- •Fever or axillary temperature> 37.0℃ before vaccination
- •Previous vaccination against HPV
- •Planned administration/administration of investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding first dose of vaccine
- •Planned to take part in other clinical research within 7 months after participating this study or have taken part in other clinical research within 3 months before participating this study
- •Abnormal laboratory tests parameters(except the part the clinician diagnosed as non clinical significance)
- •Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination
- •Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days
- •History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
- •History of to adverse event to vaccine, or allergic to some food or drug
- •History of epilepsy, seizures or convulsions, or family history of mental illness
- •Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
- •Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
- •Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes, malignant tumor, all kinds of infectious diseases and acute illness, or during chronic disease acute attack period
- •Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
- •Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months
- •During acute disease (including infectious and non-infectious disease) and chronic diease period of onset
- •Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years
- •Planned to move out of local before the end of the study or leave the local for a long time during the study period
- •Other unsuitable factors for the study judged by investigators
结局指标
主要结局
Number of Subjects Reporting Unsolicited Adverse Events
时间窗: 30 days after each vaccination
Number of Subjects Reporting Serious Adverse Events
时间窗: 30 days after third dose of vaccination
Number of Subjects Reporting Solicited Adverse Events
时间窗: 7 days after each vaccination
次要结局
- Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58(30 days after third dose of vaccination)
研究者
研究点 (1)
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