Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ™)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62,626
- 主要终点
- Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance
研究概览
简要总结
To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Receipt of Menactra vaccine during the study period.
排除标准
- 未提供
结局指标
主要结局
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance
时间窗: Day 0 up to Day 60 post-vaccination
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.
次要结局
未报告次要终点