NCT03998449已完成不适用
Evaluation of Immunogenicity of Cholera Vaccine in Children With Inflammatory Bowel Disease
Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Achieving seroprotective antibody concentration
研究概览
简要总结
Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
- •no vaccination against cholera in the past,
- •written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.
排除标准
- •serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) > 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) > 40 points for patients with Crohn's disease.
结局指标
主要结局
Achieving seroprotective antibody concentration
时间窗: 4-6 weeks after the second dose
Serum antibody concentration indicating protection against cholera.
次要结局
- Inflammatory bowel disease exacerbation occurrence.(4-6 weeks after the second dose)
- Adverse effects(3 days after each dose)
研究者
Lukasz Dembinski
Principal Investigator
Medical University of Warsaw
研究点 (2)
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