Vaccine Exposure in Patients With MS

Multiple Sclerosis Clinical Trial

— Enquête Vaccin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191669
• Other study ID #: 69HCL17_0169
• Status: Completed
• First received: June 16, 2017
• Last updated: April 12, 2018
• Start date: June 26, 2017
• Est. completion date: July 7, 2017

Study information

• Verified date: June 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: July 7, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Multiple sclerosis according to MacDonald 2010 criteria

• Age 18 and more

Exclusion Criteria:

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Neurologique Pierre Wertheimer	Bron
France	Service de Neurologie - Hôpital G. Montpied	Clermont-Ferrand
France	Service de Neurologie - CHU de Grenoble	Grenoble
France	Cabinet de Neurologie - Clinique de la Sauvegarde	Lyon
France	Service de Neurologie - Hôpital Saint Joseph Saint Luc	Lyon
France	Service de Neurologie - Hôpital Nord - CHU St Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients exposed to seasonal flu vaccine in 2016-2017		Two-weeks period in July 2017