NCT00927719已完成不适用
A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 897,227
- 主要终点
- To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine
研究概览
简要总结
This is an enhanced safety surveillance study that will occur within the military Service Member population.
Primary Objective:
- To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.
Secondary Objectives:
- To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination.
- To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.
详细描述
The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine
时间窗: Entire study duration
次要结局
未报告次要终点
研究者
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