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Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05788510
Acronym
TNF-VAX
Enrollment
106
Registered
2023-03-29
Start date
2023-04-03
Completion date
2023-05-06
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Vaccine

Keywords

Pneumococcal vaccine, Immunosupressed patients, Immunization status, Anti-TNF alpha

Brief summary

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.

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.

Interventions

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

Sponsors

Hôpital NOVO
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 treatmentAt the end of the study, an average of one monthPresence 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

MeasureTime frameDescription
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 therapyAt the end of the study, an average of one monthNumber of patients who received a complete pneumococcal vaccination before initiation of treatment and the number of patients who received it after
Assessment of the number of injections prescribed and/or performed (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) for each patientAt the end of the study, an average of one monthNumber of patients who received an incomplete vaccination scheme (1 dose of Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent).
Evaluation of the prescription or completion of the vaccination according to the characteristics of the patients and their comorbidities.At the end of the study, an average of one monthAnalysis 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 .....).
Evaluation of the prescription or completion of the vaccination according to the medical specialty of the prescriberAt the end of the study, an average of one monthAnalysis of the data to identify any significant differences according to the medical specialty of the prescriber.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026