NCT03281174已完成不适用
Phase IV, Open-labelled, Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- The seropositive rate of EV71 neutralizing antibody-1
研究概览
简要总结
The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.
详细描述
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014.
On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with 435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).
- •The subjects in Sheyang immunogenicity subgroup with the following conditions were included in this study:
- •Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
- •Received at least one injection of EV71 vaccine or the placebo in the phase III clinical trial
- •Finished the blood sampling 64 months after the vaccination
排除标准
- •Received extra EV71 vaccination after the phase III clinical trial
- •Refused to join the study
结局指标
主要结局
The seropositive rate of EV71 neutralizing antibody-1
时间窗: 5 years (64 months)
Calculated based on the cutoff value of 1:8
次要结局
- The seropositive rate of EV71 neutralizing antibody-3(5 years (64 months))
- The seropositive rate of EV71 neutralizing antibody-2(5 years (64 months))
- The GMT of EV71 neutralizing antibody(5 years (64 months))
研究者
研究点 (1)
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