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Vaccine Exposure in Patients With MS (Enquête Vaccin)

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Civil Hospices of Lyon

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Other: Auto-questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT03191669
69HCL17_0169

Details and patient eligibility

About

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.

Enrollment

335 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

335 participants in 1 patient group

MS patients
Description:
Single group of patients with MS attending an outpatient MS clinic or hospitalization
Treatment:
Other: Auto-questionnaire

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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