NCT00884182已完成2 期
Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 13
- 主要终点
- To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine.
研究概览
简要总结
This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic.
Study objectives:
- To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule.
- To describe the immune response after each vaccination in subjects receiving study vaccine.
详细描述
Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.
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
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 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 of the Split Virion Pandemic Influenza vaccine.
时间窗: 21 days post-vaccination and entire study
次要结局
- To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine.(21 days post-vaccination)
研究者
研究点 (13)
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