Pneumococcal VaccineTNF-VAXNCT05788510
Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy
An observational study of Pneumococcal Vaccine, run by Hôpital NOVO at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumococcal Vaccine
- What is being tested?
- Pneumococcal vaccine
- Type of treatment
- Vaccines
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2023to 6 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having received anti-TNF alpha treatment between 2020 and 2022 at the NOVO Hospital - Pontoise site
Who may be able to join
- Patients treated with anti-TNF alpha between 2020 and 2022 at the NOVO Hospital - Pontoise site
Who cannot join
- Patients with an indication for pneumococcal vaccination who have received a full vaccination regimen prior to the decision to start anti-TNF alpha
Trial locations and contacts
1 site in 1 country.
France1 site
Internal Medicine Department - NOVO Hospital - Pontoise site
Pontoise, 95300
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumococcal Vaccine
- Being tested
- Pneumococcal vaccine
- Keywords
- Pneumococcal vaccine, Immunosupressed patients, Immunization status, Anti-TNF alpha
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal vaccineOther
Investigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy
| Study group | Role | What they receive |
|---|---|---|
| Pneumococcal vaccine | Investigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy Receives: Other: Pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Number of patients who received a complete pneumococcal vaccination before initiation of treatment and the number of patients who received it after
Measured: 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
Number of patients who received an incomplete vaccination scheme (1 dose of Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent).
Measured: 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.
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 .....).
Measured: 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
Analysis of the data to identify any significant differences according to the medical specialty of the prescriber.
Measured: At the end of the study, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start3 Apr 2023
- Primary completion6 May 2023
- Study completion6 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Christine Trumtel, Principal investigator, NOVO Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788510
- Sponsor's protocol ID
- CHRD 0423
- Acronym
- TNF-VAX
- Status last verified
- May 2023
- First submitted
- 15 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy: Status Report on the NOVO Hospital - Pontoise Site
- ClinicalTrials.gov ID
- NCT05788510
- Acronym / sponsor ID
- TNF-VAX / CHRD 0423
- Conditions
- Pneumococcal Vaccine
- Keywords
- Pneumococcal vaccine, Immunosupressed patients, Immunization status, Anti-TNF alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal vaccine | – | Other: Pneumococcal vaccineInvestigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having received anti-TNF alpha treatment between 2020 and 2022 at the NOVO Hospital - Pontoise site
Key inclusion criteria (1 listed)
- Patients treated with anti-TNF alpha between 2020 and 2022 at the NOVO Hospital - Pontoise site
Key exclusion criteria (1 listed)
- Patients with an indication for pneumococcal vaccination who have received a full vaccination regimen prior to the decision to start anti-TNF alpha
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumococcal vaccineInvestigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy | Other | Pneumococcal vaccine |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- COVARISQ (estimation de la COuverture VAccinale des adultes à RISQues) : taux de vaccination des immunodéprimés en France en 2017Link provided by the sponsor.
- Haut Conseil de Santé Public - Vaccination des personnes immunodéprimées ou aspléniques - Recommandations - Rapport 2012Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Christine Trumtel principal investigator
NOVO Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Vaccine, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.