CTRI/2025/06/088685尚未招募4 期
An open-label, multicentre, phase IV clinical study to assess the safety and immunogenicity of VaxiRab N® administered for prophylaxis against rabies.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 28
- 主要终点
- To assess the safety profile of VaxiRab N® administered for prophylaxis against rabies
研究概览
简要总结
An open-label, multicentre,phase IV clinical study to assess the safety and immunogenicity of VaxiRab N®administered for prophylaxis against rabies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects for pre-exposure prophylaxis or subjects with WHO category II or III animal bites for post-exposure prophylaxis against rabies
- •Written informed consent and assent (if applicable) from adult subjects or parents of minor subjects (less than 18 years)
- •Participants or parents of participants with adequate literacy to fill the diary. Category II.
- •nibbling of uncovered skin, minor scratches or abrasions without bleeding, licks on broken skin Category III – single or multiple transdermal bites or scratches, contamination of mucous membrane with saliva from licks; exposure to bat bites or scratches.
排除标准
- •History of anaphylaxis or serious reactions to other vaccines
- •History of suturing of the wound or application of irritants at the wound site
- •Participants with any clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, or immunological disorder
- •History of any serious chronic illness or immunosuppression (immunosuppressive illness or therapy) or on steroids
- •Subjects with any acute febrile illness (body temperature greater than or equals to 37.5°C) at the time of enrolment
- •Pregnant or lactating women or planning to become pregnant in the next one year
- •Participation in any clinical trial in the last 3 months
- •Patient with history of drug or alcohol abuse
- •Received any type of rabies vaccine or any dose of rabies immunoglobulin in the past
- •Treated with antimalarial drugs in last 2 months
- •Any other vaccine administration within 30 days of initiation of the study.
结局指标
主要结局
To assess the safety profile of VaxiRab N® administered for prophylaxis against rabies
时间窗: Week 1, Week 2, Week 4
次要结局
- To evaluate the immunogenicity of VaxiRab N® in a subset of 10 percent of subjects
研究者
研究点 (28)
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