Phase 4 Study of Speeda® Rabies Vaccinia That Use for Protection the Crowd Bitten by Animals to Three-level
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Observation of the subject after injured by the animals carrying the virus
研究概览
简要总结
The objective of this study was to achieve the post-marketing protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.
详细描述
When found the injury who is bitten by the animal to three-level, the investigators would enroll the participant after explaining the protection and making him signed the informed consent. The patient would inject rabies vaccine as follow the national regulation, meanwhile the investigators would get the blood samples to detect whether the man-killer carries the rabies virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
- •Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months before injured
- •The man-killer could found and detect whether it carries the virus
排除标准
- •Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- •Apply passive immunity preparation
研究组 & 干预措施
rabies vaccine
When injured by the animal who carries the rabies virus, the patient after standard treatment would survive or die
干预措施: rabies vaccine (Biological)
结局指标
主要结局
Observation of the subject after injured by the animals carrying the virus
时间窗: 2 years
Whether or when would the patients develop symptoms after injured by the animals carrying the virus
次要结局
未报告次要终点