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