EUCTR2011-003243-21-ES进行中（未招募）1 期
Randomized, comparative and prospective clinical trial evaluating efficacy and safety of a dose of seasonal flu vaccine compared to two doses of vaccine for prevention of influenza in solid organ transplant recipients
Fundación Pública Andaluza Progreso y Salud0 个研究点目标入组 499 人开始时间: 2011年8月9日最近更新:
适应症
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
- 499
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
- 性别
- All
入选标准
- •1. solid organ transplant receipation.
- •2. 16 years or older.
- •3. More than 30 days after transplantation.
- •4. Negative pregnancy test for women of childbearing age
- •5. The patient must give informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 46
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1. No written informed consent.
- •2. Acute rejection within 15 days prior to vaccination.
- •3. Pregnancy.
- •4. Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins.
- •5. History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).
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