NCT01548118Unknown1 期
A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions.
研究概览
简要总结
This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 female between, and including, 9 and 45 years of age at the time of the first vaccination
- •Provide legal identification for for the sake of recruitment.
- •Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition).
- •Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months.
排除标准
- •History of cervical cancer
- •History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
- •History of allergic to vaccine, or to any ingredient of vaccine.
- •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.
- •History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
- •Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
- •Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
- •Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
- •Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days.
- •Fever or axillary temperature> 37.0 °C before vaccination
- •During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month
- •History of hypertension, physical examination systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mmHg
- •Abnormal laboratory tests parameters
- •Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study
结局指标
主要结局
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions.
时间窗: 7 days after each vaccine dose
Occurrence, intensity and relationship to vaccination of any unsolicited symptom.
时间窗: 30 days after finish vaccinations
次要结局
- Neutralizing antibody responses of HPV 16/18 after each vaccine dose.(30 days after finish vaccinations)
研究者
研究点 (1)
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