An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine
试验速览
- 阶段
- 不适用
- 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 the second year observation period after the second vaccination
研究概览
简要总结
The purpose of this follow-up study is to evaluate the two-year 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 III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.
This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.
排除标准
- •subjects who refuse to continue in the study.
结局指标
主要结局
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
时间窗: Within the second year after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
次要结局
- The GMT of anti-EV71 antibodies in serum two years after second vaccination(26 months after second vaccination)
- Frequency of serious adverse events (SAEs) with the second year after the second vaccination(within the second year after the second vaccination)