Safety Observation of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine (JEV-I) Given With Primary Immunization in a Large Amount of Healthy Children Aged 8 Months and Older
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,357
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events
研究概览
简要总结
This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older.
详细描述
Healthy children aged 8 months and older who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province will be invited to participate in this study. No study vaccine will be supplied or administered as part of this study, participants will be monitored following vaccine administration in clinical settings.
The primary immunization program with JEV-I requires 2 intramuscular doses administered 7-10 days apart. All participants will be observed for the incidence of any adverse events (AEs) within 30 minutes and from 30 minutes to 7 days after each vaccination, including local and systemic reactions. Additionally, all participants will be observed for unsolicited AEs within 30 days after after each vaccination.
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
- 8 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children who have received the inactivated Japanese encephalitis vaccine.
- •Legal guardian of the participants voluntarily participates in the clinical trial and signs an informed consent form.
- •Legal guardian of the subject has the ability to understand the procedures of the study and accept all scheduled visits.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events
时间窗: 30 days following each vaccination
Adverse events (AEs) are defined as all adverse medical events that occur in participants after receiving the investigational drug, which can manifest as symptoms, signs, diseases, or abnormal laboratory tests, but they may not necessarily have a causal relationship with the investigational drug. Unsolicited AEs will be collected within 30 days after each dose of vaccine administration, while solicited adverse reactions will be collected within 30 minutes and 30 minutes to 7 days after each dose of vaccine administration. A structured form (pre-listed) will be used to record the local and systemic reactions collected below. Local reactions: * Pain * Induration * Ecchymosis (Redness) * Pruritus * Rash Systemic reactions: * Headache * Courbature (not from injection site) * Diarrhea * Dysphagia * Anorexia * Vomiting * Sickness * Cough * Dyspnea * Irritability * Sleepiness * Acute allergic reaction * Pain (not from injection site)
次要结局
未报告次要终点