NCT00569894已完成不适用
A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29,296
- 试验地点
- 1
- 主要终点
- Assess Medically Attended Events(MAEs)of anaphylaxis,urticaria, asthma,wheezing,pre-specified grouped diagnoses,and rare events related to wild-type influenza,MAEs-qualify as SAEs,in:emergency department,clinic,and hospital setting.
研究概览
简要总结
To assess the safety of FluMist vaccination
详细描述
- To assess the safety of FluMist vaccination Rates of medically attended events in FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza, will be compared to rates in multiple non-randomized control groups.
- To assess the safety of annual FluMist re-vaccination [Rates of MAEs in the subset of children who receive FluMist in ≥2 consecutive years will be compared to rates in first-time vaccinees during the same season.]
- To assess the safety of FluMist vaccination in children previously vaccinated with trivalent inactivated influenza vaccine (TIV) [Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.]
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: born within the same calendar quarter as the reference FluMist vaccinee.
排除标准
- •Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.
结局指标
主要结局
Assess Medically Attended Events(MAEs)of anaphylaxis,urticaria, asthma,wheezing,pre-specified grouped diagnoses,and rare events related to wild-type influenza,MAEs-qualify as SAEs,in:emergency department,clinic,and hospital setting.
时间窗: 1, 3, 21, or 42 days post dose; 6 months post dose; entire study period)
次要结局
未报告次要终点
研究者
研究点 (1)
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