NCT00311493已完成4 期
A Phase IV, Randomized, Open-Label, Multi-Center Study in Adults: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer) in Study V48P2E1, 5 Years After First Booster Immunization and Evaluation of Booster Kinetics in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer), 5 Years After First Booster Immunization
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
研究概览
简要总结
The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both sexes aged >18 who participated in another study on TBE vaccination
排除标准
- •Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
结局指标
主要结局
Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
次要结局
- Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.
研究者
研究点 (1)
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