NCT00260351已完成4 期
Immunogenicity and Safety of Purified Vero Cell Rabies Vaccine (PVRV, Verorab™) Administered for Rabies Post-exposure Treatment. Comparison of Essen-IM, Zagreb-IM, and Thai Red Cross (TRC)-ID Regimens in the Indian Population.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 3
- 主要终点
- Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine
研究概览
简要总结
- To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or,
- To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure.
Secondary objectives:
- To describe the immunogenicity profile of each regimen
- To assess the safety of the vaccine in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with WHO category III rabies exposure
- •Subject aged at least 2 years old (day of second birthday)
排除标准
- •Subject unable to comply with the follow-up schedule of the protocol
- •Delayed post-exposure treatment (>72 hours between incident and treatment
- •Subject bitten by an observable animal at the inclusion visit
- •Subject with immune-compromised or underlying diseases which may lead to inferior immune response
- •Subject with known pregnancy at the time of inclusion
- •Subject enrolled or scheduled to be enrolled in another clinical study.
- •Subject with acute febrile illness/ axillary temperature > 37.5 degree celsius
- •Subject in whom blood sampling will be difficult.
- •Subject receiving chloroquine or other anti-malarial treatment
- •Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs
- •Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.)
- •Previous rabies immunization
- •Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin
- •Subject with clinical signs of rabies
- •Subject with known allergy to vaccine components (e.g. neomycin)
- •Subject who received blood and/or plasma transfusion within the past 3 months
结局指标
主要结局
Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine
时间窗: 6 months post-vaccination
次要结局
未报告次要终点
研究者
研究点 (3)
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