NCT00161746已完成2 期
Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 7
研究概览
简要总结
The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.
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 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children aged between 6 and 47 months
- •No history of any previous TBE vaccination
- •Clinically healthy
- •Informed consent provided by the parents
排除标准
- •History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
- •Suffering from a disease that cannot be effectively treated or stabilised
- •Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
- •Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
- •HIV-positivity (no special HIV test required for the purpose of the study)
- •Suffering from a febrile disease
- •History of vaccination against yellow fever and/or Japanese encephalitis
- •Participation in another clinical trial
研究者
研究点 (7)
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