NCT00192218已完成4 期
A Phase IV Study to Evaluate the Effectiveness of Flumist (Influenza Vaccine, Live Intranasal) Vaccination in a School-Based Intervention Program
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,022
- 试验地点
- 4
- 主要终点
- To compare the families of children in the target schools with families of children in the control schools with respect to workdays lost by adults and school days lost by children.
研究概览
简要总结
To measure the effectiveness of influenza vaccination in school children by comparing, between target(i.e., children are offered FluMist) and control (i.e., children are not offered FluMist) school families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children enrolled in the target schools.
- •Written informed consent obtained from the child's parent(s) if they agree to participate.
排除标准
- •History of severe hypersensitivity (anaphylactic response) to egg products or previous FluMist
- •FluMist is licensed exclusively for use in healthy individuals age 5-49 years. Therefore children for whom annual receipt of inactivated influenza vaccine for specific medical condition(s) is recommended will not be eligible. These conditions include:
- •Asthma, other chronic pulmonary diseases, kidney disease, metabolic disease, heart disease, or hemoglobinopathy
- •Immunosuppression of child
- •Severe immunosuppression of a household member
- •Pregnancy
- •Past history of Guillian-Barre Syndrome
- •Aspirin therapy within 1 month prior to FluMist or the anticipated use of aspirin containing products for one month after FluMist administration
- •Administration of any inactivated vaccine within 2 weeks or any live vaccine within 4 weeks prior to receipt of FluMist
- •Received anti-influenza medication in the past 48 hours
- •Fever in the past 72 hours
- •Moderate to severe nasal congestion (inability to breathe through the nose) or acute phase URI symptoms until the congestion has improved
结局指标
主要结局
To compare the families of children in the target schools with families of children in the control schools with respect to workdays lost by adults and school days lost by children.
时间窗: 7 days after each vaccination
次要结局
- Absenteeism - To compare the families of children in the target schools to those in the control schools with respect to the overall increase in absenteeism during the influenza outbreak, using aggregated (summary) absentee rates.(between outbreak and non-outbreak weeks)
- Herd Community - To compare unvaccinated children in the target schools to the children in the control schools with respect to changes in absentee rates between outbreak weeks and non-outbreak weeks.(between outbreak and non-outbreak weeks)
研究者
研究点 (4)
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