CClinicalTrials.gg
CompletedNCT03191669Enquête VaccinUpdated Apr 13, 2018

Vaccine Exposure in Patients With MS

An observational study in Multiple Sclerosis, sponsored by Hospices Civils de Lyon. Completed at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-13.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
335
Ages
18 Years and older
Sex
All
01

Study 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-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.

02

Conditions studied

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 335 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with MS attending an outpatient MS clinic or hospitalization

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
335 participants (actual)
Patient registry
No

Groups and cohorts

  • MS patients

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

    Other: Auto-questionnaire

Interventions

  • OtherAuto-questionnaire

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

06

What researchers measure

Primary outcomes

  1. Percentage of patients exposed to seasonal flu vaccine in 2016-2017

    Time frame: Two-weeks period in July 2017

07

Study locations

6 sites
  • Hôpital Neurologique Pierre Wertheimer
    Bron, 69500, France
  • Service de Neurologie - Hôpital G. Montpied
    Clermont-Ferrand, 63003, France
  • Service de Neurologie - CHU de Grenoble
    Grenoble, 38043, France
  • Service de Neurologie - Hôpital Saint Joseph Saint Luc
    Lyon, 69007, France
  • Cabinet de Neurologie - Clinique de la Sauvegarde
    Lyon, 69009, France
  • Service de Neurologie - Hôpital Nord - CHU St Etienne
    Saint-Étienne, 42055, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03191669
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jun 19, 2017
Start date
Jun 26, 2017
Primary completion
Jul 7, 2017
Completion
Jul 7, 2017
Last update
Apr 13, 2018

Study contacts

Sandra VUKUSIC
principal investigator · Hôpital Neurologique Pierre Wertheimer - GHE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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