EUCTR2014-005105-20-Outside-EU/EEA进行中（未招募）不适用
A phase IV, uncontrolled, open-label, multi-center study in children and adolescents: Evaluation of long-term immunogenicity in subjects boosted with a new pediatric TBE vaccine (free of protein-derived stabilizer) in study V48P4E1, five years after first booster immunization
ovartis Vaccines and Diagnostics0 个研究点目标入组 232 人开始时间: 2014年11月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 232
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Individuals meeting all of the following criteria were eligible for enrollment into the study:
- •Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.
- •Informed consent was obtained for all the subjects before enrollment into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 232
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •In this study subjects who received a booster immunization since termination of study V48P4E2 were not excluded. They were asked to consent that the information of the booster immunization could be implemented in the database for statistical reason and to use the serum samples of previous studies for avidity determination.
研究者
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