NCT00981513已完成4 期
Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6,300
- 试验地点
- 1
- 主要终点
- Clinical influenza by self-reported symptoms, specifically defined as at least two of fever ≥37.8ºC, cough, headache, sore throat, aches or pains in muscles or joints
研究概览
简要总结
The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hong Kong residents aged between 7 and 11 and their family members.
排除标准
- •Children with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.
- •Children receiving aspirin therapy or aspirin-containing therapy.
- •Children with asthma or active wheezing.
- •Children or family members with underlying immunocompromised condition or receiving immunosuppressive agents.
结局指标
主要结局
Clinical influenza by self-reported symptoms, specifically defined as at least two of fever ≥37.8ºC, cough, headache, sore throat, aches or pains in muscles or joints
时间窗: One year
Influenza virus infection confirmed by RT-PCR
时间窗: One year
次要结局
- Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.(One year)
- Adverse events following vaccination(7 days)
研究者
研究点 (1)
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