NCT04939350

Brief Summary

the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the

Trial Health

87
On Track

Trial Health Score

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

Enrollment
742

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

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

First Submitted

Initial submission to the registry

June 15, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2022

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

June 15, 2021

Last Update Submit

May 21, 2026

Conditions

Keywords

Vaccinal coveragevaccinationcirrhosiscirrhoticCOVIDhepatitis Bhepatitis Ainfluenzae viruspneumococcustetanuspoliomyelitis

Outcome Measures

Primary Outcomes (1)

  • percentage fully immunization coverage

    percentage of patients fully vaccinated against polio DT, seasonal influenza, HAV, HBV, pneumococcal and COVID19 in our sample

    Day 0

Secondary Outcomes (6)

  • percentage DTpolio immunization coverage

    Day 0

  • percentage HAV immunization coverage

    Day 0

  • percentage HBV immunization coverage

    Day 0

  • percentage Pneumococcal immunization coverage

    Day 0

  • percentage Influenza virus immunization coverage

    Day 0

  • +1 more secondary outcomes

Interventions

patients will complete a vaccination questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All cirrhotic patients followed for at least 6 months in consultation or hospitalization during the duration of the study in the general hospitals members of the ANGH participating in the study.

You may qualify if:

  • adult patient
  • histologically proven or asserted cirrhosis on a combination of clinical, biological, endoscopic and radiological criteria
  • follow-up of cirrhosis \> 6 months
  • subject informed of the study and not having objected to it.

You may not qualify if:

  • immunosuppression not related to liver disease: HIV, variable common immune deficiency, chemotherapy, anatomical splenectomy, immunosuppressive treatments for non-hepatic disease
  • vaccine contraindication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

Location

MeSH Terms

Conditions

FibrosisHepatitis BHepatitis ATetanusPoliomyelitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesMyelitisCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 25, 2021

Study Start

September 27, 2021

Primary Completion

December 27, 2022

Study Completion

December 27, 2022

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations