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临床试验/NCT01666535
NCT01666535已完成不适用

Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial

University of Calgary2 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
2
主要终点
Serologic protection

研究概览

简要总结

The investigators will compare the immunogenicity of influenza vaccine in adults and children with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab dosing. The primary objective is to compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase from pre to post-vaccination titer) to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
9 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of IBD established by accepted criteria
  • On maintenance infliximab administered every 6 to 8 weeks (already received at least 6 weeks of infliximab)
  • Between ages 9 and 60 years

排除标准

  • Hypersensitivity reaction to previous dose of influenza vaccine
  • Known hypersensitivity to eggs or chicken or other components of influenza vaccine

结局指标

主要结局

Serologic protection

时间窗: 28 days ± 3 days after influenza vaccination

To compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40.

次要结局

  • Immunogenic response(28 days ± 3 days after influenza vaccination)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer deBruyn

Assistant Professor

University of Calgary

研究点 (2)

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