NCT00370864已完成2 期
Phase II Study of a Pandemic Influenza Vaccine in Children
Seqirus3 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2006年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Safety and immunogenicity
研究概览
简要总结
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy 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
- Double
入排标准
- 年龄范围
- 6 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged greater or equal to 6 months to less than 9 years
- •Normal gestation period
排除标准
- •History of clinically significant medical conditions
- •History of Guillain Barre syndrome or active neurological disease
结局指标
主要结局
Safety and immunogenicity
次要结局
未报告次要终点
研究者
研究点 (3)
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