Pneumococcal Vaccination in Patients With Anti-TNF Alpha Therapy (TNF-VAX)

May 26, 2023 updated by: Centre Hospitalier René Dubos

Pneumococcal Vaccination in Patients With Anti-TNF Alpha Therapy: Status Report on the NOVO Hospital - Pontoise Site

As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital.

The aim of this study is to assess the status of pneumococcal vaccination in patients at the NOVO hospital - Pontoise site, who have received anti-TNF alpha therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Immunosuppressed patients are at risk of infections, sometimes severe with life-threatening consequences. Some of these are vaccine-preventable, notably pneumococcal infections. Specific vaccination recommendations have been published since 2012 by the French High Council for Public Health. However, vaccine coverage is below the desired immunisation objectives for immunosuppressed patients.

As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital, in order to propose, if necessary, measures, in particular a specialised consultation, with the aim of improving the vaccination coverage of this population at risk The aim of this study is to assess the status of pneumococcal vaccination in patients who have received anti-TNF alpha therapy.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Pontoise, France, 95300
        • Internal Medicine Department - NOVO Hospital - Pontoise site
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients having received anti-TNF alpha treatment between 2020 and 2022 at the NOVO Hospital - Pontoise site

Description

Inclusion Criteria :

  • Patients treated with anti-TNF alpha between 2020 and 2022 at the NOVO Hospital - Pontoise site

Exclusion Criteria :

  • Patients with an indication for pneumococcal vaccination who have received a full vaccination regimen prior to the decision to start anti-TNF alpha

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pneumococcal vaccine
Investigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy
Other: Pneumococcal vaccine
Investigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the prescription of a pneumococcal vaccination (Conjugated or Unconjugated Pneumococcal Vaccine) by doctors practising at the NOVO Hospital - Pontoise site, in patients receiving anti-TNF alpha treatment
Time Frame: At the end of the study, an average of one month
Presence or absence of a prescription or completion of a complete pneumococcal vaccination (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) recorded in the patient's medical file.
At the end of the study, an average of one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the timing of the vaccines (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) in relation to the date of initiation of anti-TNF alpha therapy
Time Frame: At the end of the study, an average of one month
Number of patients who received a complete pneumococcal vaccination before initiation of treatment and the number of patients who received it after
At the end of the study, an average of one month
Assessment of the number of injections prescribed and/or performed (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) for each patient
Time Frame: At the end of the study, an average of one month
Number of patients who received an incomplete vaccination scheme (1 dose of Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent).
At the end of the study, an average of one month
Evaluation of the prescription or completion of the vaccination according to the characteristics of the patients and their comorbidities.
Time Frame: At the end of the study, an average of one month
Analysis of the data to identify any significant differences according to the characteristics of the vaccinated and non-vaccinated patients (comorbidities, pathology for which the treatment was introduced .....).
At the end of the study, an average of one month
Evaluation of the prescription or completion of the vaccination according to the medical specialty of the prescriber
Time Frame: At the end of the study, an average of one month
Analysis of the data to identify any significant differences according to the medical specialty of the prescriber.
At the end of the study, an average of one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: Dr Christine Trumtel, NOVO Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Actual)

May 6, 2023

Study Completion (Actual)

May 6, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD 0423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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