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Primary Sjögren SyndromeVACGRENNCT04224454

Vaccine Coverage and Primary Sjögren'Syndrome

An observational study of Primary Sjögren Syndrome, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of vaccination coverage for influenza, pneumococcus and DTP in patients with pSS and investigated the reasons for non-vaccination. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Sjögren Syndrome
What is being tested?
Questionnaire
Type of treatment
Vaccines
How many people
111 participants
Where
1 siteFrance
Study dates
1 Jan 2016to 30 Nov 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: Consecutive patients with primary Sjögren'syndrome

Who may be able to join

  • patients with pSS according to European-American Diagnostic Criteria

Who cannot join

  • Refusal to participate

Trial locations and contacts

1 site in 1 country.

France1 site
  • Uhmontpellier

    Montpellier, 34295

Other trials in France

About this study

Official title: Influenza, Pneumococcal and Diphtheria-tetanus-poliomyelitis Vaccine Coverage in Patients With Primary Sjögren's Syndrome: a Cross-sectional Study

Evaluation of vaccination coverage for influenza, pneumococcus and DTP in patients with pSS and investigated the reasons for non-vaccination.

Read the detailed description

A cross-sectional study was performed in pSS patients from two different French tertiary referral centers for autoimmune diseases (Paris-Bicêtre and Montpellier). From January 2016 to November 2017, questionnaires were randomly delivered to patients with pSS according to European-American Diagnostic Criteria (2002). Before completing the questionnaire, patients gave their consent to participate. This questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow (HL) to limit missing data.

Data collected in the questionnaire included previous vaccinations, reasons for non-vaccination, sources of vaccine proposition, and sociodemographic data including education level (Bachelor degree, and post-Bachelor degree education) and presence of young child(ren) (inferior 10 years old) at home. The following data was collected from the medical file: European-American Diagnostic Criteria (2002) for pSS, the most recent EULAR Sjögren's syndrome disease activity index (ESSDAI), comorbidities (chronic lung diseases, diabetes, chronic kidney diseases, chronic liver diseases, chronic heart diseases, cardiovascular comorbidities [coronary or cerebral ischemia] and severe neurological or muscle diseases), history of severe A cross-sectional study was performed in pSS patients from two different French tertiary referral centers for autoimmune diseases (Paris-Bicêtre and Montpellier). From January 2016 to November 2017, questionnaires were randomly delivered to patients with pSS according to European-American Diagnostic Criteria (2002). Before completing the questionnaire, patients gave their consent to participate. This questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow (HL) to limit missing data. Data collected in the questionnaire included previous vaccinations, reasons for non-vaccination, sources of vaccine proposition, and sociodemographic data including education level (Bachelor degree, and post-Bachelor degree education) and presence of young child(ren) (inferior 10 years old) at home. The following data was collected from the medical file: European-American Diagnostic Criteria (2002) for pSS, the most recent EULAR Sjögren's syndrome disease activity index (ESSDAI), comorbidities (chronic lung diseases, diabetes, chronic kidney diseases, chronic liver diseases, chronic heart diseases, cardiovascular comorbidities [coronary or cerebral ischemia] and severe neurological or muscle diseases), history of severe infection (requiring intravenous antibiotics or hospital admission), current smoking status, treatments used for pSS including hydroxychloroquine, immunosuppressive drugs (methotrexate, leflunomide, ciclosporine, azathioprine, mycophenolate mofetil) and biological disease-modifying anti-rheumatic drugs (bDMARDs).

For descriptive statistical analysis, mean more or less SD were used for continuous variables and frequencies (percentage) for categorical variables. To evaluate factors associated with up-to-date vaccination, the investigators compared categorical variables between patients with updated and non-updated influenza, pneumococcal or DTP vaccines by using the Fisher exact test or chi-square test as appropriate. Continuous variables (age, ESSDAI) were compared by Student t test. A binary logistic regression model was used for multivariate analysis to estimate the odds ratio (OR) of being vaccinated with the 95% confidence interval (CI). p< 0.05 was considered statistically significant. All statistical analyses were performed with IBM SPSS 15 software.

Being tested
Questionnaire
Keywords
Vaccine, Coverage, Sjögren's syndrome
Medical subject headings
Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow to limit missing data.

Study groups in NCT04224454
Study groupRoleWhat they receive
Primary Sjögren's syndrome111 consecutive patients with primary Sjögren's syndrome (European-American 2002 criteria)
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients with Sjögren's syndrome vaccinated against influenzae virus

    Rate of patients with Sjögren's syndrome vaccinated against influenzae virus: number of patients vaccinated against influenzae virus within 1 year divided to the number of patients not vaccinated against influenzae virus within 1 year

    Measured: 1 year

  2. Rate of patients with Sjögren's syndrome vaccinated against streptococcus pneumoniae

    Rate of patients with Sjögren's syndrome vaccinated against streptococcus pneumoniae: number of patients vaccinated against streptococcus pneumoniae within 5 years divided to the number of patients not vaccinated against streptococcus pneumoniae within 5 years

    Measured: 5 years

  3. Rate of patients with Sjögren's syndrome vaccinated against DTP

    Rate of patients with Sjögren's syndrome vaccinated against DTP : number of patients vaccinated for DTP within 10 years divided to the number of patients not vaccinated for DTP within 10 years

    Measured: 10 years

Secondary outcomes (1)
  1. Evaluate the reasons for non-vaccination

    Evaluate the reasons for non-vaccination : The questionnaire was adapted from questionnaires used by the French national agency "Institut de Veille Sanitaire" to study vaccination coverage and were completed with the assistance of one fellow (HL) to limit missing data (18). Data collected in the questionnaire included previous vaccinations, reasons for non-vaccination, sources of vaccine proposition, and sociodemographic data including education level (Bachelor degree, and post-Bachelor degree education) and presence of young child(ren) (<10 years old) at home.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start1 Jan 2016
  3. Primary completion1 Nov 2017
  4. Study completion30 Nov 2017

Resources

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
Cross-sectional
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04224454
Sponsor's protocol ID
RECHMPL19_0612
Acronym
VACGREN
Status last verified
Jan 2020
First submitted
2 Jan 2020
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Publications

  • Gluthmann J FL, Bonmarin I, Levy-Bruhl D. Enquête nationale de couverture vaccinale, France, janvier 2011. http://www.invs.sante.fr. . 2001.

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Sjögren Syndrome, run by University Hospital, Montpellier at 1 site 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 1 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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Rate of patients with Sjögren's syndrome vaccinated against influenzae virus (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04224454, which also lists 1 linked publication.

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 Jan 2020.

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