Vaccine Exposure in Patients With MS

NCT ID: NCT03191669

Last Updated: 2018-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-26

Study Completion Date

2017-07-07

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MS patients

Single group of patients with MS attending an outpatient MS clinic or hospitalization

Auto-questionnaire

Intervention Type OTHER

Single Auto-questionnaire administered during or after a consultation/hospitalization

Interventions

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Auto-questionnaire

Single Auto-questionnaire administered during or after a consultation/hospitalization

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra VUKUSIC

Role: PRINCIPAL_INVESTIGATOR

Hôpital Neurologique Pierre Wertheimer - GHE

Locations

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Hôpital Neurologique Pierre Wertheimer

Bron, , France

Site Status

Service de Neurologie - Hôpital G. Montpied

Clermont-Ferrand, , France

Site Status

Service de Neurologie - CHU de Grenoble

Grenoble, , France

Site Status

Service de Neurologie - Hôpital Saint Joseph Saint Luc

Lyon, , France

Site Status

Cabinet de Neurologie - Clinique de la Sauvegarde

Lyon, , France

Site Status

Service de Neurologie - Hôpital Nord - CHU St Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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69HCL17_0169

Identifier Type: -

Identifier Source: org_study_id

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