NCT03998215已完成不适用
Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease
Medical University of Warsaw0 个研究点目标入组 46 人开始时间: 2012年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- Achieving seroprotective antibody concentration
研究概览
简要总结
Assessment of the immunogenicity and safety of booster immunization against diphtheria 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
- 11 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),
- •vaccination, as a part of the basic vaccination course, with five doses of diphtheria, tetanus and whole-cell pertussis vaccine, without booster dose after the age of 6,
- •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.
研究组 & 干预措施
Diphtheria booster vaccination
Experimental
One booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis
干预措施: Diphtheria booster vaccination (Biological)
结局指标
主要结局
Achieving seroprotective antibody concentration
时间窗: after 4-8 weeks
Antibody concentrations ≥0.1 IU/ml indicated protection against diphtheria, while levels ≥1.0 IU/ml were considered to ensure long-term protection.
次要结局
- Booster response(after 4-8 weeks)
- Adverse effects(3 days)
- Inflammatory bowel disease exacerbation occurrence.(after 4-8 weeks)
研究者
Lukasz Dembinski
Principal Investigator
Medical University of Warsaw
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