NCT04224454

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

January 2, 2020

Last Update Submit

January 9, 2020

Conditions

Keywords

VaccineCoverageSjögren's syndrome

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    10 years

Secondary Outcomes (1)

  • Evaluate the reasons for non-vaccination

    1 day

Study Arms (1)

Primary Sjögren's syndrome

111 consecutive patients with primary Sjögren's syndrome (European-American 2002 criteria)

Other: Questionnaire

Interventions

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.

Primary Sjögren's syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with primary Sjögren'syndrome

You may qualify if:

  • \- patients with pSS according to European-American Diagnostic Criteria

You may not qualify if:

  • \- Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jacques MOREL, Professor

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 13, 2020

Study Start

January 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 30, 2017

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations