Multiple SclerosisEnquête VaccinNCT03191669
Vaccine Exposure in Patients With MS
An observational study of Multiple Sclerosis, run by Hospices Civils de Lyon at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Auto-questionnaire
- How many people
- 335 participants
- Where
- 6 sitesFrance
- Study dates
- 26 Jun 2017to 7 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with MS attending an outpatient MS clinic or hospitalization
Who may be able to join
- Multiple sclerosis according to MacDonald 2010 criteria
- Age 18 and more
Who cannot join
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Neurologique Pierre Wertheimer
Bron, 69500
Service de Neurologie - Hôpital G. Montpied
Clermont-Ferrand, 63003
Service de Neurologie - CHU de Grenoble
Grenoble, 38043
Service de Neurologie - Hôpital Saint Joseph Saint Luc
Lyon, 69007
Cabinet de Neurologie - Clinique de la Sauvegarde
Lyon, 69009
Service de Neurologie - Hôpital Nord - CHU St Etienne
Saint-Etienne, 42055
About this study
Official title: 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.
Read more
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Auto-questionnaire
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-questionnaireOther
Single Auto-questionnaire administered during or after a consultation/hospitalization
| Study group | Role | What they receive |
|---|---|---|
| MS patients | Single group of patients with MS attending an outpatient MS clinic or hospitalization Receives: Other: Auto-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients exposed to seasonal flu vaccine in 2016-2017
Measured: Two-weeks period in July 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start26 Jun 2017
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra VUKUSIC, Principal investigator, Hôpital Neurologique Pierre Wertheimer - GHE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191669
- Sponsor's protocol ID
- 69HCL17_0169
- Acronym
- Enquête Vaccin
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Exposure in Patients With Multiple Sclerosis in the Auvergne-Rhone-Alpes Region
- ClinicalTrials.gov ID
- NCT03191669
- Acronym / sponsor ID
- Enquête Vaccin / 69HCL17_0169
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS patients | – | Other: Auto-questionnaireSingle group of patients with MS attending an outpatient MS clinic or hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with MS attending an outpatient MS clinic or hospitalization
Key inclusion criteria (2 listed)
- Multiple sclerosis according to MacDonald 2010 criteria
- Age 18 and more
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-questionnaireSingle Auto-questionnaire administered during or after a consultation/hospitalization | Other | MS patients |
Primary outcome
Percentage of patients exposed to seasonal flu vaccine in 2016-2017
Time frame: Two-weeks period in July 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra VUKUSIC principal investigator
Hôpital Neurologique Pierre Wertheimer - GHE
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients exposed to seasonal flu vaccine in 2016-2017 (time frame: Two-weeks period in July 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.