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OpenTrials
Completed

NCT Number: NCT03191669

Vaccine Exposure in Patients With MS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Neurologique Pierre Wertheimer, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Auto-questionnaire

Other

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

Primary outcomes

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

    Time frame: Two-weeks period in July 2017

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Enquête Vaccin

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2017
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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