Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization With Other Vaccines in Shanghai
试验速览
- 阶段
- 不适用
- 入组人数
- 12,500
- 试验地点
- 6
- 主要终点
- Safety index-The incidence of adverse reactions
研究概览
简要总结
This study is an open clinical trial of the EV71 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co.,Ltd.The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), Inactivated co-administration with other vaccines
详细描述
This study is an open clinical trial in children aged 6-71 months old. The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), inactivated co-administration with other vaccines.The EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 12500 subjects aged 6-71 months old were enrolled.All subjects received one dose of EV71 vaccine and one of other vaccines(such as MMR vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •6 months ≤ Age of enrollment ≤71 months;
- •Voluntary and self-funded completion of EV71 vaccine combined immunization with one of the other type I or II vaccines;
- •The subject and/or guardian can understand and voluntarily sign the informed consent form;
- •Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes).
排除标准
- 未提供
结局指标
主要结局
Safety index-The incidence of adverse reactions
时间窗: From 0 to 30 days after vaccination
The incidence of adverse reactions 0-30 days after vaccination of EV71 vaccine combined immunization with other vaccines.
Safety index-incidence of local and systemic adverse reactions
时间窗: From 0 to 3 days after vaccination
Incidence of local and systemic adverse reactions 0 to 3 days after each dose of EV71 vaccine combined immunization with other vaccines (except live attenuated vaccines)
Safety index-the incidence of local and systemic adverse reactions
时间窗: From 0 to 14 days after vaccination
The incidence of local and systemic adverse reactions 0 to 14 days after each dose of EV71 vaccine combined with live attenuated vaccine
Safety index-Incidence of serious adverse reactions
时间窗: From 0 to 30 days after vaccination
Incidence of serious adverse reactions 0 to 30 days after vaccination of EV71 vaccine combined immunization with other vaccines.
次要结局
未报告次要终点