Vaccine Exposure in Patients With MS (Enquête Vaccin)
Vaccine Exposure in Patients With Multiple Sclerosis in the Auvergne-Rhone-Alpes Region
Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s and more recently human papillomavirus vaccine. There was an important flu incidence during the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been evaluated yet.
Objectives The primary objective is to evaluate exposure to the flu vaccine in patients with MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify potential limitations to vaccines in general in patients with MS.
Methods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes (France).
Data will be collected through an auto-questionnaire administered during an out-patient visit or hospitalization, during a two-week period.
Statistical analysis Description of the percentage of patients exposed to the flu vaccine, and to other vaccines. Stratification according to demographics (age, sex) and MS related criteria (disability level, relapse in the year before, disease-modifiying drug) Expected results Vaccine exposure of patients with MS will be put in perspective with the general population exposure. The study can provide information regarding potential reluctance of patients with MS towards vaccines. This could lead to develop specific communication tools for patients with MS and/or health professionals.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bron、法国、69500
- Hopital Neurologique Pierre Wertheimer
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Clermont-Ferrand、法国、63003
- Service de Neurologie - Hôpital G. Montpied
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Grenoble、法国、38043
- Service de Neurologie - CHU de Grenoble
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Lyon、法国、69007
- Service de Neurologie - Hôpital Saint Joseph Saint Luc
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Lyon、法国、69009
- Cabinet de Neurologie - Clinique de la Sauvegarde
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Saint-Étienne、法国、42055
- Service de Neurologie - Hôpital Nord - CHU St Etienne
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Multiple sclerosis according to MacDonald 2010 criteria
- Age 18 and more
Exclusion Criteria:
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学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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MS patients
Single group of patients with MS attending an outpatient MS clinic or hospitalization
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Single Auto-questionnaire administered during or after a consultation/hospitalization
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Percentage of patients exposed to seasonal flu vaccine in 2016-2017
大体时间：Two-weeks period in July 2017
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Two-weeks period in July 2017
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合作者和调查者
调查人员
- 首席研究员：Sandra VUKUSIC、Hôpital Neurologique Pierre Wertheimer - GHE
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 69HCL17_0169
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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Auto-questionnaire的临床试验
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Fisher and Paykel HealthcareHelios Klinik Ambrock完全的
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Shenzhen Second People's Hospital未知
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Lisata Therapeutics, Inc.完全的
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Autolus Limited邀请报名多发性骨髓瘤 | DLBCL | T细胞淋巴瘤 | 患者在首次接受 AUTO CAR T 细胞疗法后长达 15 年的随访 | 所有，成人和儿童美国, 英国