Vaccine Exposure in Patients With MS (Enquête Vaccin)

April 12, 2018 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hôpital Neurologique Pierre Wertheimer
      • Clermont-Ferrand, France, 63003
        • Service de Neurologie - Hôpital G. Montpied
      • Grenoble, France, 38043
        • Service de Neurologie - CHU de Grenoble
      • Lyon, France, 69007
        • Service de Neurologie - Hôpital Saint Joseph Saint Luc
      • Lyon, France, 69009
        • Cabinet de Neurologie - Clinique de la Sauvegarde
      • Saint-Étienne, France, 42055
        • Service de Neurologie - Hôpital Nord - CHU St Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with MS attending an outpatient MS clinic or hospitalization

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MS patients
Single group of patients with MS attending an outpatient MS clinic or hospitalization
Other: Auto-questionnaire
Single Auto-questionnaire administered during or after a consultation/hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients exposed to seasonal flu vaccine in 2016-2017
Time Frame: Two-weeks period in July 2017
Two-weeks period in July 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sandra VUKUSIC, Hôpital Neurologique Pierre Wertheimer - GHE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Actual)

July 7, 2017

Study Completion (Actual)

July 7, 2017

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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