CTRI/2019/06/019622进行中（未招募）4 期
A Phase IV, Randomized, Controlled Study of the Safety and Immunogenicity of Rabishield, Rabivax-S Post-exposure Prophylaxis regimen in Patients with Potential Rabies Exposure
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients aged more than 2 years of either sex
- •2. WHO Category III exposure(s) by a suspected rabid animal < 72 hours prior to enrollment and < 24 hours if exposure to face, neck, hand or fingers.
- •3. Written informed consent by subjects (>=18 years) / parents of subjects (2-17 years).
- •4. Written informed assent by subjects aged 7-17 years
排除标准
- •1. Previous receipt of complete PEP or pre-exposure prophylaxis with modern cell culture rabies vaccine.
- •2. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric,
- •cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination, which in the opinion of the investigator might interfere with the study objectives.
- •3. Major congenital defects or serious chronic illness.
- •4. History of thrombocytopenia or known bleeding disorders.
- •5. Receipt of other investigational study agent within previous 30 days or planned during the course of this study.
- •6. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant participating in the study or making it unlikely the subject could complete the protocol.
研究者
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