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临床试验/NCT03191669
NCT03191669已完成不适用

Vaccine Exposure in Patients With Multiple Sclerosis in the Auvergne-Rhone-Alpes Region

Hospices Civils de Lyon6 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2017年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
335
试验地点
6
主要终点
Percentage of patients exposed to seasonal flu vaccine in 2016-2017

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Multiple sclerosis according to MacDonald 2010 criteria
  • Age 18 and more

排除标准

  • 未提供

结局指标

主要结局

Percentage of patients exposed to seasonal flu vaccine in 2016-2017

时间窗: Two-weeks period in July 2017

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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