NCT02912845已完成3 期
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Kamada, Ltd.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
研究概览
简要总结
The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies Immunoglobulin) in children ages 0 months to <17 years, when administered as part of post-Rabies Exposure Prophylaxis (PEP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy children (male and female) ages 0 months to <17 years.
- •Have been exposed or possibly exposed to rabies.
- •Are indicated to receive post-exposure prophylaxis (PEP) against rabies infection.
- •Have documented informed consent from the child's parent(s) or legal guardian(s) and assent from the child if appropriate.
排除标准
- •History of previous administration of rabies vaccine or human rabies immune globulin (HRIG)
- •Rabies exposure or possible rabies exposure more than seven days prior to initiation of PEP, or timing of exposure unknown
研究组 & 干预措施
20 IU/kg KamRAB + Active Anti-Rabies Vaccine
Experimental
干预措施: KamRAB - HRIG (Drug)
结局指标
主要结局
Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
时间窗: Within 14 days from treatment
Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
时间窗: Within 84 days of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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