EUCTR2006-003651-20-FR进行中（未招募）1 期
A Phase III Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids
aboratoires Merck Sharp & Dohme - Chibret0 个研究点目标入组 300 人开始时间: 2007年1月19日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Age=60 years.
- •2. A history of varicella or long-term residence in a country with endemic VZV infection.
- •3. Receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone during the 8 weeks immediately prior to enrolment.
- •4. Expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior history of HZ
- •2. Prior receipt of any varicella or zoster vaccine.
- •3. Any use in the 8 weeks prior to vaccination or for 6 weeks postvaccination of concomitant immunosuppressive medications (e.g. corticosteroids >20 mg daily, chemotherapeutic agents, immunomodulating drugs, immunosuppressive treatments associated with solid organ or bone marrow transplantation.
研究者
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