NCT00298701已完成1 期
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of GRAZAX-R in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Assessment of safety by recording of adverse events
研究概览
简要总结
This trial is performed to assess whether the Grazax-R treatment is safe to use in children aged 5-12 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grass pollen induced rhinoconjunctivitis
- •Boys and girls, 5-12 years of age
- •Positive skin prick test to grass pollen
排除标准
- •Previous treatment with immunotherapy
结局指标
主要结局
Assessment of safety by recording of adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
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