EUCTR2009-011523-31-GB进行中（未招募）不适用
A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC
R & D, Cambridge University Hospitals0 个研究点目标入组 60 人开始时间: 2009年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Male or non-pregnant, non-lactating female patients, 18 to 50 years of age (inclusive)
- •Diagnosis of MS using the McDonald’s criteria10
- •Received alemtuzumab at least 4 weeks previously
- •If receiving Revaxis must have been previously vaccinated against tetanus (for the tetanus vaccine to stimulate the desired recall response)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previously received Haemophilus b or pneumococcal vaccines or have had Haemophilus or pneumococcal disease (these antigens are intended to be novel to the subject’s immune system)
- •Allergy to a component in any of the vaccines
- •Previous or current immune thrombocytopaenic purpura (ITP) or haemolytic anaemia.
- •Received a diphtheria or tetanus toxoid vaccine within the last 5 years; only applicable if the patient will be given Revaxis (vaccination recommended after 5 years to minimise adverse events)
- •Guillain-Barré syndrome or brachial neuritis due to a previous vaccine
- •Acute severe febrile illness
研究者
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