A Multicentered, Double - Blind, Randomized, and Placebo - Controlled Clinical Trial With Inactivated Enterovirus Type 71 (EV71) Vaccines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10,077
- 试验地点
- 3
- 主要终点
- The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.
详细描述
The phase II study of inactivated vaccine (vero cell) against EV71 has completed on Dec 2011 in China. The data from the phase I and II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. In order to evaluate the efficacy of the vaccine against Hand, Foot and Mouth disease caused by EV71, and to further explore the safety profile of this vaccine in expending infant population, a phase III clinical trial is planed to conduct.
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
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
- •Provided legal identification for the sake of recruitment
- •Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents
排除标准
- •History of Hand-foot-mouth Disease
- •Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
- •Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- •Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
- •Epilepsy, seizures or convulsions history, or family history of mental illness
- •Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
- •History of asthma, angioedema, diabetes or malignancy
- •History of thyroidectomy or thyroid disease that required medication within the past 12 months
- •Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- •Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
- •Acute illness or acute exacerbation of chronic disease within the past 7 days
- •Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- •History of any blood products within 3 months
- •Administration of any live attenuated vaccine within 14 days
- •Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 days
- •Axillary temperature > 37.0 centigrade before vaccination
- •Abnormal laboratory parameters before vaccination
- •Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
结局指标
主要结局
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination
时间窗: From 28 days after the second vaccination to one year
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
次要结局
- The GMT of anti-EV71 antibodies in serum after second vaccination(28 days after first vaccination)
- The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination(7 and 13 months after second vaccination)
- Frequency of systemic and local adverse reactions after the first vaccination(28 days after the first vaccination)
- Frequency of systemic and local adverse reactions after the second vaccination(28 days after the second vaccination)