A Phase III Clinical Trial With Randomized, Double-blinded, Controlled Design as Well as Bridging Design to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Children Aged 36-71 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8
研究概览
简要总结
The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
详细描述
This study is a randomized, double-blind, single-center, controlled phase III clinical trial in children aged 36-71 months, and bridging trial between agegroup of 6-35 and 36-71 months. The purpose of this study is to evaluate the immunogenicity and safety of the experimental EV71 vaccine in children aged 36-71 months. The primary objective of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, and the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The secondary objective is to evaluate the safety of the experimental vaccine used in children aged 36-71 months. The experimental vaccine is manufactured by Sinovac Biotech Co., Ltd, and the control vaccine is manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences. 600 children aged 36-71 months will be randomly assigned in to receive the experimental vaccine or control vaccine, and 300 children aged 6-35 months will receive the experimental vaccine.
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 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers ≥ 2 years old;
- •Proven legal identity;
- •Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment.
排除标准
- •Prior vaccination with EV71 vaccine;
- •History of hand, foot and mouth disease;
- •History of allergy to any vaccine or vaccine ingredient, asthma, serious adverse reactions to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- •Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- •Autoimmune disease or immunodeficiency/immunosuppressive;
- •Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- •History of thyroidectomy, no spleen and functional spleen;
- •Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- •Receipt of any of the following products:
- •Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry
- •Blood products within 2 months prior to study entry
- •Any other investigational products (drug or vaccine）within 30 days prior to study entry
- •Any live attenuated vaccine within 14 days prior to study entry
- •Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- •Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- •Axillary temperature > 37.0 °C;
- •Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
结局指标
主要结局
The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8
时间窗: 30 days after two doses
Subjects whose pre-immune antibody titer \< 1:8 and post-immune antibody titer ≥ 1:8, or those whose pre-immune antibody titer ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
The Geometric mean titer (GMT) of the EV71 neutralizing antibody in the susceptible population
时间窗: 30 days after two doses
The susceptible population refer to the subjects whose pre-immune antibody titer \<1:8
次要结局
- The overall incidence of adverse reactions(0-30 days after each dose)
- The incidence of the serious adverse events (SAE)(0-30 days after each dose)
- The Geometric mean titer (GMT) of the EV71 neutralizing antibody(30 days after two doses)
- The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:16, 1:32, and 1:64 respectively(30 days after two doses)