NCT00161772已完成2 期
Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 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
- 46
研究概览
简要总结
The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.
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
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children will be eligible for participation in this study if:
- •they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old;
- •they are clinically healthy;
- •their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent;
- •their legal representative agrees to keep a Volunteer Diary.
排除标准
- •Children will be excluded from participation in this study if they:
- •have a history of any previous TBE vaccination;
- •have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);
- •have a history of allergic reactions, in particular to one of the components of the vaccine;
- •have received antipyretics within 4 hours prior to the first TBE vaccination;
- •suffer from a disease that cannot be effectively treated or stabilized;
- •suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions;
- •suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;
- •are known to be HIV positive (a special HIV test is not required for the purpose of the study);
- •suffer from a febrile illness at study entry;
- •have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
- •are participating simultaneously in another clinical trial.
研究者
研究点 (46)
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