CTRI/2011/07/001857已完成4 期
A phase IV, multi-center, randomized, open-label study of PCECV (Rabipur®) comparing the immunogenicity and safety of two different simulated post exposure schedules (Zagreb 2-1-1 versus Essen regimen 1-1-1-1-1) in Healthy Indian subjects - Rabipur study
ovartis Healthcare Pvt Ltd0 个研究点目标入组 250 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
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.Males and femalesof age greater than and equal to 18 years.
- •2. Individuals who have given written consent.
- •3. Individuals in good health and available for all the visits scheduled in the study
排除标准
- •1.Pregnancy or unwillingness to practice acceptable contraception.
- •2.A history of Rabies immunization.
- •3.History of allergy to egg protein.
- •4.Known hypersensitivity to neomycin, or any other vaccine component.
- •5.A significant acute or chronic infectious disease or use of antibiotics that may impact the subjects safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
- •6.Body temperature greatr than or equal to 38.0°C (greater than or equal to 100.4° F) within 3 days of study vaccination.
- •7.Treatment with an anti-malarial drug, up to two months prior to the study.
- •8.Individuals who received any other vaccines within 28 days prior to enrollment.
- •9.Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- •10.Any planned surgery during the study period.
- •11.Subjects who have cancer disorders excluding nonmelanotic skin cancer.
研究者
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