Vaccine Exposure in Patients With MS
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Auto-questionnaire
- Registration Number
- NCT03191669
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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-Rh么ne-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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 335
- Multiple sclerosis according to MacDonald 2010 criteria
- Age 18 and more
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MS patients Auto-questionnaire Single group of patients with MS attending an outpatient MS clinic or hospitalization
- Primary Outcome Measures
Name Time Method Percentage of patients exposed to seasonal flu vaccine in 2016-2017 Two-weeks period in July 2017
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
H么pital Neurologique Pierre Wertheimer
馃嚝馃嚪Bron, France
Service de Neurologie - CHU de Grenoble
馃嚝馃嚪Grenoble, France
Cabinet de Neurologie - Clinique de la Sauvegarde
馃嚝馃嚪Lyon, France
Service de Neurologie - H么pital G. Montpied
馃嚝馃嚪Clermont-Ferrand, France
Service de Neurologie - H么pital Nord - CHU St Etienne
馃嚝馃嚪Saint-脡tienne, France
Service de Neurologie - H么pital Saint Joseph Saint Luc
馃嚝馃嚪Lyon, France