---
title: Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
nct_id: NCT04939350
overall_status: COMPLETED
sponsor: Centre Hospitalier Sud Francilien
study_type: OBSERVATIONAL
primary_condition: Cirrhosis
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04939350.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04939350"
ct_last_update_post_date: 2023-02-16
last_seen_at: "2026-05-12T06:51:46.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021

**Official Title:** Evaluation of the Vaccination Coverage in a Prospective Cohort of Cirrhotic Patients Followed in the General Hospitals in France in 2021 and in 2022.

**NCT ID:** [NCT04939350](https://clinicaltrials.gov/study/NCT04939350)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 742
- **Lead Sponsor:** Centre Hospitalier Sud Francilien
- **Conditions:** Cirrhosis
- **Start Date:** 2021-09-27
- **Completion Date:** 2022-12-27
- **CT.gov Last Update:** 2023-02-16

## 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

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

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

## Interventions

- **questionnaire** (OTHER) — patients will complete a vaccination questionnaire

## Primary Outcomes

- **percentage fully immunization coverage** _(time frame: Day 0)_ — percentage of patients fully vaccinated against polio DT, seasonal influenza, HAV, HBV, pneumococcal and COVID19 in our sample

## Secondary Outcomes

- **percentage DTpolio immunization coverage** _(time frame: Day 0)_
- **percentage HAV immunization coverage** _(time frame: Day 0)_
- **percentage HBV immunization coverage** _(time frame: Day 0)_
- **percentage Pneumococcal immunization coverage** _(time frame: Day 0)_
- **percentage Influenza virus immunization coverage** _(time frame: Day 0)_
- **percentage COVID immunization coverage** _(time frame: Day 0)_

## Locations (1)

- Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre hospitalier sud francilien|corbeil-essonnes||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04939350*  
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