ClinicalTrials.gg
CompletedNCT04939350VACCIRUpdated May 22, 2026

Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021

An observational study in Cirrhosis, sponsored by Centre Hospitalier Sud Francilien. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Primary conditionFibrosis(the registry's first term)UnverifiedIs this wrong?Fibrosis is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Centre Hospitalier Sud Francilien · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
742
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

Cirrhosis is a serious liver disease very common in France, affecting nearly 200,000 people. These patients have an impaired immune response. They are, therefore, more frequently prone to bacterial, viral and fungal infections and these are more severe with high mortality. 30-50% of cirrhotics admitted to a hospital ward have sepsis, with pneumococcal bacterial infections being particularly severe. The risk of developing seasonal influenza is 5.7 times higher in cirrhotics with a risk of mortality multiplied by 169. COVID19 infection is responsible for a very high mortality (34%) in case of severe resuscitation form. Acute infections with hepatitis A (HAV) and B (HBV) viruses frequently lead to worsening liver failure decompensating to cirrhosis, and sometimes life-threatening fulminant hepatitis. Finally, chronic infection with the hepatitis B virus combined with another etiology of cirrhosis accelerates the course of liver disease and promotes the occurrence of hepatocellular carcinoma.

Limiting the incidence of viral and bacterial infections in these patients is crucial. The High Authority of Health (HAS) published recommendations in 2007 advising patients with cirrhosis vaccinations against hepatitis A and B viruses, influenza and against bacterial pneumococcal infections, confirmed by the High Council of Public Health.

There are few data on vaccination coverage among cirrhotic patients. An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the hepatitis A virus. No recent studies have assessed the impact of the HAS recommendations.

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

02

Conditions studied

  • Cirrhosis

Browse trials for

Keywords

  • Vaccinal coverage
  • vaccination
  • cirrhosis
  • cirrhotic
  • COVID
  • hepatitis B
  • hepatitis A
  • influenzae virus
  • pneumococcus
  • tetanus
  • poliomyelitis
03

In context

Fibrosis Unverified

1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.

This study's enrollment of 742 is above the median of 157 across 386 observational studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Centre Hospitalier Sud Francilien is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Compared within Fibrosis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult patient
  • 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.

Exclusion criteria

Exclusion Criteria:

  • not related to liver disease: , variable common immune deficiency, chemotherapy, anatomical splenectomy, immunosuppressive treatments for non-hepatic disease
  • vaccine .
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
742 participants (actual)
Patient registry
No

Interventions

  • Otherquestionnaire

    patients will complete a vaccination questionnaire

06

What researchers measure

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

    Time frame: Day 0

Secondary outcomes

  1. percentage DTpolio immunization coverage

    Percentage of vaccination against DTPolio

    Time frame: Day 0

  2. percentage HAV immunization coverage

    Percentage of vaccination against HAV

    Time frame: Day 0

  3. percentage HBV immunization coverage

    Percentages of vaccination against HBV

    Time frame: Day 0

  4. percentage Pneumococcal immunization coverage

    Percentages of vaccination against pneumococcaL

    Time frame: Day 0

  5. percentage Influenza virus immunization coverage

    Percentage of vaccination against seasonal influenza

    Time frame: Day 0

  6. percentage COVID immunization coverage

    Percentage of vaccination against COVID19

    Time frame: Day 0

07

Study locations

1 site
  • Centre Hospitalier Sud Francilien
    Corbeil-Essonnes, France 91106, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04939350
Lead sponsor
Centre Hospitalier Sud Francilien
Responsible party
Sponsor
First posted
Jun 25, 2021
Start date
Sep 27, 2021
Primary completion
Dec 27, 2022
Completion
Dec 27, 2022
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion