NCT01067079终止不适用
A Phase III, Single Center, Open Label, Follow-up Immunogenicity Study in Subjects Who Previously Received Post-exposure Rabies Vaccine According to the Essen or 2:1:1 (Zagreb) Schedule
Novartis Vaccines0 个研究点目标入组 200 人开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 主要终点
- Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL
研究概览
简要总结
This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study
排除标准
- •Any disease condition, that in the opinion of investigator may interfere with subjects ability to participate in the study.
- •Receipt of additional doses of rabies vaccine after completion of initial vaccine series.
- •For additional entry criteria please refer to protocol.
结局指标
主要结局
Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL
时间窗: 13 months, 3 years and 5 years after initial vaccination
次要结局
- Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration(13months, 3 years and 5years after initial vaccination)
研究者
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