Safety Observation of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old Vaccinated With Live Attenuated Mumps Vaccines in Shanxi Province
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 3
- 主要终点
- Safety index-the incidence of local and systemic adverse reactions
研究概览
简要总结
This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the safety of live attenuated mumps vaccines after large-scale application and accumulate safety data for the application of live attenuated mumps vaccines,and provide scientific basis for the formulation of vaccine immunization prevention strategies.
详细描述
This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.Bao'ji, Xian'yang, Yan 'an and Han'zhong of Shaanxi Province were selected as the research center.A total of 10000 junior high school students under 14 years old who voluntarily received a dose of live attenuated mumps vaccines were be enrolled.Adverse reactions/events at 30 minutes, 14 days and 30 days after vaccination of live attenuated mumps vaccine were were collected by face-to-face or telephone follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Junior high school students under 14 years old;
- •The subjects and guardians of the subjects 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 local and systemic adverse reactions
时间窗: From 0 day to 14 days after vaccination
The incidence of local and systemic adverse reactions from 0 day to 14 days after vaccination.
Safety index-The incidence of local and systemic adverse reactions
时间窗: From 0 day to 30 days after vaccination.
The incidence of local and systemic adverse reactions from 0 day to 30 days after vaccination.
次要结局
未报告次要终点