NCT02200237已完成2 期
A Clinical Study for Inactivated Vaccine Against EV71
Medigen Vaccine Biologics Corp.4 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 4
- 主要终点
- To evaluate overall safety of EV71 vaccine in children, throughout the study period
研究概览
简要总结
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
- •The subjects' guardians are able to understand and sign the informed consent
排除标准
- •Subject with previous known exposure to EV
- •Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
- •Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
- •Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period.
- •Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
- •Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
研究组 & 干预措施
Placebo
Placebo Comparator
Phosphate Buffer Saline with adjuvant aluminium phosphate
干预措施: Placebo (Biological)
EV71 with adjuvant aluminium phosphate
Experimental
Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml
干预措施: EV71 with adjuvant aluminium phosphate (Biological)
结局指标
主要结局
To evaluate overall safety of EV71 vaccine in children, throughout the study period
时间窗: 2 years after study initiation
Occurrence of overall adverse events and serious adverse events during the entire period of study.
次要结局
- To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine(2 years from study initiation)
研究者
研究点 (4)
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