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 Geometric mean titer (GMT) of the EV71 neutralizing antibody in the susceptible population
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.
研究组 & 干预措施
Experimental group
36-71 months old children-experimental EV71 vaccine.
干预措施: 36-71 months old children-experimental EV71 vaccine. (Biological)
Vaccine-controlled group
36-71 months old children-control EV71 vaccine.
干预措施: 36-71 months old children-control EV71 vaccine. (Biological)
Age-controlled group
6-35 months old children-experimental EV71 vaccine.
干预措施: 6-35 months old children-experimental EV71 vaccine. (Biological)
结局指标
主要结局
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
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.
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)