Impact of Vaccine Funding by the National Health Insurance on Vaccination Coverage Among Patients Targeted by Current Vaccination Recommendations and Followed in Outpatient Consultations (VAXINOVA)

April 2, 2026 updated by: Assistance Publique - Hôpitaux de Paris

"Assessment of the Impact of Vaccine Funding by the National Health Insurance on Vaccination Coverage Among Patients Targeted by Current Vaccination Recommendations and Followed in Outpatient Consultations in Ile-de-France Region in France""

The objective of our study is to evaluate the impact of vaccine funding for patients seen in outpatient consultations within four healthcare institutions in the Ile-de-France region in France, made possible through the establishment of a tripartite agreement between the hospital group, the Île-de-France Regional Health Agency (ARS IDF), and the Primary Health Insurance Fund (CPAM).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this project is to highlight whether dedicated funding for vaccine procurement in healthcare institutions can generate both individual and collective benefits in terms of improved vaccination coverage among vulnerable patients at infectious risk.

Should the data analysis demonstrate a positive impact on vaccination coverage among patients who attended outpatient consultations in the participating institutions during the study period, it is planned to approach the Directorate General for Health with a view to generalizing such agreements between healthcare institutions and local health insurance organizations, thereby enabling reimbursement of vaccines included in the national immunization schedule administered within these institutions.

Primary objective: To assess the impact of National Health Insurance (NHI) funding for vaccines made available in outpatient consultations on pertussis vaccination coverage among pregnant women and pneumococcal vaccination coverage among eligible patients, in accordance with current French recommendations and fully covered by NHI, across four healthcare institutions in the Île-de-France region.

Secondary objectives:

To evaluate:

  • The influence of socio-economic determinants on patients' vaccination coverage;
  • Changes in the practices of hospital healthcare professionals in outpatient consultations regarding the monitoring of their patients' vaccination status;
  • Changes in practices related to the documentation of patient vaccinations to facilitate communication between healthcare institutions and primary care practitioners through the use of existing digital tools (hospital software, electronic vaccination record (CVE) in MonEspaceSanté).

Study Type

Observational

Enrollment (Estimated)

2920

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
      • Fontainebleau, France, 77300
        • Not yet recruiting
        • Sud Seine Et Marne Hospital
        • Contact:
      • Montereau-Fault-Yonne, France, 77130
        • Not yet recruiting
        • Sud Seine Et Marne Hospital
        • Contact:
      • Nemours, France, 77140
        • Not yet recruiting
        • Sud Seine Et Marne Hospital
        • Contact:
      • Rambouillet, France, 78120
      • Saint-Denis, France, 93200
    • IDF
      • Paris, IDF, France, 75014
        • Recruiting
        • COCHIN HOSPITAL - Assistance Publique-Hôpitaux de Paris (APHP)
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

During a follow-up hospital consultation, for patients eligible for pneumococcal vaccination or for postpartum women eligible for pertussis vaccination during pregnancy, the healthcare professional proposes and completes a questionnaire with the patient during the consultation.

Description

Inclusion Criteria:

For patients:

  1. For the assessment of pneumococcal coverage among patients eligible for this vaccination:

    • Individuals aged 18 years or older,
    • Individuals followed in outpatient consultations within a department and healthcare institution participating in the project;
    • Individuals eligible for pneumococcal vaccination against according to current French recommendations,
    • Individuals meeting the eligibility conditions and receiving care under long-term illness coverage (ALD) or benefiting from complementary universal health coverage (C2S) or state medical aid (AME).

  2. For the assessment of pertussis vaccination among pregnant women:

    • Women aged 18 years or older,
    • Women who have had at least one follow-up outpatient consultation from 20 weeks of gestation in a maternity ward participating in the project,
    • Women in the immediate postpartum period (during their maternity stay) who have given birth to one or more live children and delivered after 36 weeks of gestation,
    • Women who have declared their pregnancy and are covered under maternity insurance (i.e., from the first day of the sixth month of pregnancy until the 12th day after delivery).

For healthcare professionals: all vaccinating healthcare providers working in a participating department or center.

Exclusion Criteria:

  • Individuals seen in settings other than outpatient consultations (day hospital, week hospital, conventional hospitalization, International Vaccination Center).

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
Women in the immediate postpartum period
Women in the immediate postpartum period (during their stay in the maternity ward) who have declared their pregnancy to the National Health Insurance, covered under maternity benefits up to the 12th day following delivery
Other: Questionnaires for patients
Questionnaires for patients
Patients eligible for pneumococcal vaccination
Patients eligible for pneumococcal vaccination who benefit from long-term illness coverage (ALD), state medical aid (AME), or complementary universal health coverage C2S
Other: Questionnaires for patients
Questionnaires for patients
Healthcare providers
Vaccinating healthcare providers + Other healthcare providers involved in the operational aspects of the project (excluding health data)
Other: Questionnaires for healthcare providers
Questionnaires for healthcare providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects vaccinated against pneumococcal infections
Time Frame: Month 3
Variation in the number of subjects vaccinated against pneumococcal infections (eligible subjects according to current recommendations) before (according to the usual intra-hospital organization) and after the implementation of the National Health Insurance funding for vaccines made available during outpatient consultations for the target populations across four healthcare institutions in the Ile-de-France region
Month 3
Number of subjects vaccinated against pneumococcal infections
Time Frame: Month 18
Number of subjects vaccinated against pneumococcal infections (eligible subjects according to current recommendations), before (according to the usual intra-hospital organization) the implementation of the National Health Insurance funding for vaccines made available during outpatient consultations for the target populations
Month 18
Number of subjects vaccinated against pertussis
Time Frame: Month 3
Variation in the number of subjects vaccinated against pertussis during pregnancy, before (according to the usual intra-hospital organization) and after the implementation of the National Health Insurance funding for vaccines made available during outpatient consultations for the target populations
Month 3
Number of subjects vaccinated against pertussis
Time Frame: Month 18
Variation in the number of subjects vaccinated against pertussis during pregnancy, before (according to the usual intra-hospital organization) and after the implementation of the National Health Insurance funding for vaccines made available during outpatient consultations for the target populations
Month 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associated factors
Time Frame: Month 3
Factors associated with pertussis vaccination among pregnant women and pneumococcal vaccination among eligible patients (including vaccination pathway, socio-demographic and socio-economic factors, category of healthcare providers involved in pregnancy follow-up, etc.),
Month 3
Associated factors
Time Frame: Month 18
Factors associated with pertussis vaccination among pregnant women and pneumococcal vaccination among eligible patients (including vaccination pathway, socio-demographic and socio-economic factors, category of healthcare providers involved in pregnancy follow-up, etc.),
Month 18
Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations
Time Frame: Month 3
Frequency with which vaccination providers offer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for these vaccinations
Month 3
Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations
Time Frame: Month 18
Frequency with which vaccination providers offer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for these vaccinations
Month 18
Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination
Time Frame: Month 3
Frequency with which vaccinating healthcare providers administer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for this vaccination
Month 3
Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination
Time Frame: Month 18
Frequency with which vaccinating healthcare providers administer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for this vaccination
Month 18
Proportion of vaccinating healthcare providers
Time Frame: Month 3
Proportion of vaccinating healthcare providers recording in a digital tool pertussis vaccinations for pregnant women and pneumococcal vaccinations for eligible patients
Month 3
Proportion of vaccinating healthcare providers
Time Frame: Month 18
Proportion of vaccinating healthcare providers recording in a digital tool pertussis vaccinations for pregnant women and pneumococcal vaccinations for eligible patients
Month 18

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin
Agence régionale de santé Ile de France
Institut de Recherche en Santé Publique, France

Investigators

  • Study Director: Marie LACHATRE, MD, Hopital Cochin - APHP
  • Study Chair: Muriel BELIAH-NAPPEZ, MD, Agence régionale de santé Ile de France

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.

General Publications

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)

November 19, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP251228
  • 2025-A01886-43 (Other Identifier: France : Ministry of Health)

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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