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NCT Number: NCT07243236

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

COCHIN HOSPITAL - Assistance Publique-Hôpitaux de Paris (APHP), Paris, IDF, France

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For patients:

  • 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).
  • 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).

Treatment and study plan

Questionnaires for patients

Other

Questionnaires for patients

Questionnaires for healthcare providers

Other

Questionnaires for healthcare providers

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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.),

  2. 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.),

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie BENHAMMANI-GODARD

CONTACT

[email protected]

0033158411190

Marie LACHATRE, MD

CONTACT

[email protected]

0033158412093

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

"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""

Acronym: VAXINOVA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Apr 8, 2026

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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