The study of the impact on a population of healthy Japanese infants post-nirsevimab entry (SYMPHONIE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 10,000
- 主要终点
- Number of patients with acute respiratory infection hospitalized at collaborating inpatient pediatric institutions by age group
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- No limit 至 5age old not（—）
- 性别
- All
入选标准
- •Children younger than 5 years old who visited sentinel medical institution in Mie Prefecture or were admitted to an inpatient medical institution
排除标准
- •Persons 5 years old or older in Mie Prefecture
结局指标
主要结局
Number of patients with acute respiratory infection hospitalized at collaborating inpatient pediatric institutions by age group
(a) Number of patients hospitalized for acute respiratory infection per 100,000 population (b) Number of deaths due to acute respiratory infection per 100,000 population
Number of patients with RSV
(a) Number of patients hospitalized for RSV infection per 100,000 population (b) Incidence of hospitalizations associated with RSV infection requiring oxygen therapy (per 100,000 population) (c) Incidence of hospitalizations associated with RSV infection requiring mechanical ventilation (per 100,000 population) (d) Incidence of deaths on admission/during hospitalization associated with RSV infection (per 100,000 population) (to evaluate causal relationship to RSV infection) (e) Age groups are classified in the same manner as the infection trends survey
次要结局
- Number of patients with acute respiratory infection hospitalized at collaborating outpatient pediatric institutions by age group
- Number of cases diagnosed with RSV by age group
- Number of RSV rapid antigen tests
- Number of positive tests (positive rate)