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.
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.
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.
- Conditions
- Primary Sjögren Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Primary Sjögren's syndrome | 111 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.
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
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
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)
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.
- First posted13 Jan 2020
- Study start1 Jan 2016
- Primary completion1 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques MOREL, Professor, Principal investigator, University Hospital, Montpellier
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza, Pneumococcal and Diphtheria-tetanus-poliomyelitis Vaccine Coverage in Patients With Primary Sjögren's Syndrome: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04224454
- Acronym / sponsor ID
- VACGREN / RECHMPL19_0612
- Conditions
- Primary Sjögren Syndrome
- Keywords
- Vaccine, Coverage, Sjögren's syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 13 Jan 2020 (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.
Evaluation of vaccination coverage for influenza, pneumococcus and DTP in patients with pSS and investigated the reasons for non-vaccination.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Sjögren's syndrome | – | Other: Questionnaire111 consecutive patients with primary Sjögren's syndrome (European-American 2002 criteria) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with primary Sjögren'syndrome
Key inclusion criteria (1 listed)
- patients with pSS according to European-American Diagnostic Criteria
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| QuestionnaireQuestionnaire 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. | Other | Primary Sjögren's syndrome |
Primary outcome
Rate of patients with Sjögren's syndrome vaccinated against influenzae virus
Time frame: 1 year
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
Rate of patients with Sjögren's syndrome vaccinated against streptococcus pneumoniae
Time frame: 5 years
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
Rate of patients with Sjögren's syndrome vaccinated against DTP
Time frame: 10 years
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
1 secondary outcome
Evaluate the reasons for non-vaccination
Time frame: 1 day
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 Jan 2020.
- BackgroundGluthmann J FL, Bonmarin I, Levy-Bruhl D. Enquête nationale de couverture vaccinale, France, janvier 2011. http://www.invs.sante.fr. . 2001.
- Individual participant dataSharing planned: Undecided. NC
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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.
Jacques MOREL, Professor principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
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.