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Completed

NCT Number: NCT05788510

Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy

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.

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Key information

Conditions

Pneumococcal Vaccine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Internal Medicine Department - NOVO Hospital - Pontoise site

Pontoise, 95300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumococcal vaccine

Other

Investigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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).

  3. 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 .....).

  4. 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.

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: TNF-VAX

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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