NCT00776750已完成4 期
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 2
- 主要终点
- Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,
研究概览
简要总结
Disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients and renal transplant recipient (RTR). The present prospective trial aims at (a) evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b) at identifying determinants of the immune response.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •maintenance hemodialysis patients or
- •renal transplant recipients (beyond month 3 after transplantation)
排除标准
- •patients with known allergy to chicken proteins
结局指标
主要结局
Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,
次要结局
- Seroresponse rate, defined as the percentage of patients with a fourfold rise in HI titer after vaccination; impact of booster vaccination on the immune response, and safety of influenza vaccination.
研究者
研究点 (2)
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