NCT01106482已完成4 期
A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
Novartis Vaccines20 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2009年5月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 20
- 主要终点
- Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
研究概览
简要总结
This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent
排除标准
- •Subjects who did not receive complete schedule of primary vaccination in the parent study
- •Subjects enrolled in other investigational studies at the same time and within the last three months
- •Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
结局指标
主要结局
Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
时间窗: 3 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination
时间窗: 4 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination
时间窗: 5 years after vaccination
次要结局
- Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination(3 years after vaccination)
- Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination(4 years after vaccination)
- Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination(5 years after vaccination)
研究者
研究点 (20)
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