NCT00311441已完成4 期
A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
研究概览
简要总结
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered 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
- Single
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female children, 1 to 10 years of age.
排除标准
- •Subjects with documented evidence of TBE
- •Subjects, who have been previously vaccinated against TBE
结局指标
主要结局
Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
次要结局
- Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever
研究者
研究点 (1)
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