Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy

NCT05788510 | Completed

• 1 other identifier: CHRD 0423
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Vaccine

Keywords

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

Outcome Measures

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

  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 Outcomes (4)

• 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

  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

  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.

  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

  At the end of the study, an average of one month

Study Arms (1)

Pneumococcal vaccine

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

Other: Pneumococcal vaccine

Interventions

Pneumococcal vaccine OTHER

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

Pneumococcal vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (1)

Internal Medicine Department - NOVO Hospital - Pontoise site

Pontoise, 95300, France

Location

Related Links

• COVARISQ (estimation de la COuverture VAccinale des adultes à RISQues) : taux de vaccination des immunodéprimés en France en 2017
• Haut Conseil de Santé Public - Vaccination des personnes immunodéprimées ou aspléniques - Recommandations - Rapport 2012

MeSH Terms

Interventions

Pneumococcal Vaccines

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Dr Christine Trumtel

  NOVO Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: April 3, 2023
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)