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Healthcare ProvidersVAXINOVANCT07243236

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

An observational study of Healthcare Providers and Postpartum, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthcare Providers, Postpartum
What is being tested?
Questionnaires for patients and Questionnaires for healthcare providers
Type of treatment
Vaccines
How many people
2,920 participants
Where
6 sitesFrance
Study dates
19 Nov 2025to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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).
Show all 12Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marie LACHATRE, MD contact

0033158412093

marie.lachatre@aphp.fr

Marie BENHAMMANI-GODARD contact

0033158411190

marie.godard@aphp.fr

6 sites in 1 country

France6 sites, 6 recruiting

  • Sud Seine Et Marne Hospital

    Fontainebleau, 77300

    Sandrine BIANGOMA, PharmD, 0033164451900, BIANGOMASandrine@ch-sud77.fr

    Not yet recruiting

  • Sud Seine Et Marne Hospital

    Montereau-Fault-Yonne, 77130

    Sandrine BIANGOMA, PharmD, 0033164451900, BIANGOMASandrine@ch-sud77.fr

    Not yet recruiting

  • Sud Seine Et Marne Hospital

    Nemours, 77140

    Sandrine BIANGOMA, PharmD, 0033164451900, BIANGOMASandrine@ch-sud77.fr

    Not yet recruiting

  • COCHIN HOSPITAL - Assistance Publique-Hôpitaux de Paris (APHP)

    Paris, IDF, 75014

    Marie LACHATRE, MD, 0033158414141, marie.lachatre@aphp.fr

    Recruiting

  • Rambouillet Hospital

    Rambouillet, 78120

    Elsa CESARIO, MD, 00331 34 83 78 70, e.cesario@ch-rambouillet.fr

    Not yet recruiting

  • Delafontaine Hospital

    Saint-Denis, 93200

    Marie-Aude KHUONG, MD, 0033142356140, marieaude.khuong@ch-stdenis.fr

    Not yet recruiting

Other trials in France

About this study

Official 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""

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).

Read the 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).
Being tested
Questionnaires for patients, Questionnaires for healthcare providers
Keywords
Vaccine coverage, Vaccine funding within healthcare institutions, Outpatient consultations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaires for patientsOther

    Questionnaires for patients

  • Questionnaires for healthcare providersOther

    Questionnaires for healthcare providers

Study groups in NCT07243236
Study groupRoleWhat they receive
Women in the immediate postpartum periodWomen 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
Receives: Other: Questionnaires for patients
Patients eligible for pneumococcal vaccinationPatients eligible for pneumococcal vaccination who benefit from long-term illness coverage (ALD), state medical aid (AME), or complementary universal health coverage C2S
Receives: Other: Questionnaires for patients
Healthcare providersVaccinating healthcare providers + Other healthcare providers involved in the operational aspects of the project (excluding health data)
Receives: Other: Questionnaires for healthcare providers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects vaccinated against pneumococcal infections

    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

    Measured: Month 3

  2. Number of subjects vaccinated against pneumococcal infections

    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

    Measured: Month 18

  3. Number of subjects vaccinated against pertussis

    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

    Measured: Month 3

  4. Number of subjects vaccinated against pertussis

    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

    Measured: Month 18

Secondary outcomes (8)

  1. Associated factors

    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.),

    Measured: Month 3

  2. Associated factors

    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.),

    Measured: Month 18

  3. Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations

    Frequency with which vaccination providers offer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for these vaccinations

    Measured: Month 3

  4. Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations

    Frequency with which vaccination providers offer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for these vaccinations

    Measured: Month 18

  5. Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination

    Frequency with which vaccinating healthcare providers administer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for this vaccination

    Measured: Month 3

  6. Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination

    Frequency with which vaccinating healthcare providers administer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for this vaccination

    Measured: Month 18

  7. Proportion of vaccinating healthcare providers

    Proportion of vaccinating healthcare providers recording in a digital tool pertussis vaccinations for pregnant women and pneumococcal vaccinations for eligible patients

    Measured: Month 3

  8. Proportion of vaccinating healthcare providers

    Proportion of vaccinating healthcare providers recording in a digital tool pertussis vaccinations for pregnant women and pneumococcal vaccinations for eligible patients

    Measured: Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start19 Nov 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Prospective
Enrolment
2,920 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07243236
Sponsor's protocol ID
APHP251228
Other IDs
2025-A01886-43
Acronym
VAXINOVA
Status last verified
Apr 2026
First submitted
17 Nov 2025
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen H, Matsumoto H, Horita N, Hara Y, Kobayashi N, Kaneko T. Prognostic factors for mortality in invasive pneumococcal disease in adult: a system review and meta-analysis. Sci Rep. 2021 Jun 4;11(1):11865. doi: 10.1038/s41598-021-91234-y.

    PubMed 34088948

  • Schnell D, Mayaux J, de Bazelaire C, Legoff J, Feuillet S, Scieux C, Andreu-Gallien J, Darmon M, Baruchel A, Schlemmer B, Azoulay E. Risk factors for pneumonia in immunocompromised patients with influenza. Respir Med. 2010 Jul;104(7):1050-6. doi: 10.1016/j.rmed.2010.01.021. Epub 2010 Feb 24.

    PubMed 20181467

  • Belsky JA, Tullius BP, Lamb MG, Sayegh R, Stanek JR, Auletta JJ. COVID-19 in immunocompromised patients: A systematic review of cancer, hematopoietic cell and solid organ transplant patients. J Infect. 2021 Mar;82(3):329-338. doi: 10.1016/j.jinf.2021.01.022. Epub 2021 Feb 4.

    PubMed 33549624

  • Garcia Garrido HM, Knol MJ, Heijmans J, van Sorge NM, Sanders EAM, Klumpen HJ, Grobusch MP, Goorhuis A. Invasive pneumococcal disease among adults with hematological and solid organ malignancies: A population-based cohort study. Int J Infect Dis. 2021 May;106:237-245. doi: 10.1016/j.ijid.2021.03.072. Epub 2021 Mar 26.

    PubMed 33781907

  • Marijam A, Vroom N, Bhavsar A, Posiuniene I, Lecrenier N, Vroling H. Systematic Literature Review on the Incidence of Herpes Zoster in Populations at Increased Risk of Disease in the EU/EEA, Switzerland, and the UK. Infect Dis Ther. 2024 May;13(5):1083-1104. doi: 10.1007/s40121-024-00963-w. Epub 2024 Apr 24.

    PubMed 38656653

  • Ellington S, Strid P, Tong VT, Woodworth K, Galang RR, Zambrano LD, Nahabedian J, Anderson K, Gilboa SM. Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-June 7, 2020. MMWR Morb Mortal Wkly Rep. 2020 Jun 26;69(25):769-775. doi: 10.15585/mmwr.mm6925a1.

    PubMed 32584795

  • Mertz D, Geraci J, Winkup J, Gessner BD, Ortiz JR, Loeb M. Pregnancy as a risk factor for severe outcomes from influenza virus infection: A systematic review and meta-analysis of observational studies. Vaccine. 2017 Jan 23;35(4):521-528. doi: 10.1016/j.vaccine.2016.12.012. Epub 2016 Dec 23.

    PubMed 28024955

  • Tubiana S, Belchior E, Guillot S, Guiso N, Levy-Bruhl D; Renacoq Participants. Monitoring the Impact of Vaccination on Pertussis in Infants Using an Active Hospital-based Pediatric Surveillance Network: Results from 17 Years' Experience, 1996-2012, France. Pediatr Infect Dis J. 2015 Aug;34(8):814-20. doi: 10.1097/INF.0000000000000739.

    PubMed 25955837

  • Fell DB, Johnson J, Mor Z, Katz MA, Skidmore B, Neuzil KM, Ortiz JR, Bhat N. Incidence of laboratory-confirmed influenza disease among infants under 6 months of age: a systematic review. BMJ Open. 2017 Sep 7;7(9):e016526. doi: 10.1136/bmjopen-2017-016526.

    PubMed 28882916

  • Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, Johannesen CK, Fernandez LV, Teirlinck AC, Wang X, Heikkinen T, Bangert M, Caini S, Campbell H, Paget J; RESCEU Investigators. Burden of Respiratory Syncytial Virus in the European Union: estimation of RSV-associated hospitalizations in children under 5 years. J Infect Dis. 2023 Nov 28;228(11):1528-1538. doi: 10.1093/infdis/jiad188.

    PubMed 37246724

  • Wyplosz B, Fernandes J, Sultan A, Roche N, Roubille F, Loubet P, Fougere B, Moulin B, Duhot D, Vainchtock A, Raguideau F, Lortet-Tieulent J, Blanc E, Moisi J, Goussiaume G. Pneumococcal and influenza vaccination coverage among at-risk adults: A 5-year French national observational study. Vaccine. 2022 Aug 5;40(33):4911-4921. doi: 10.1016/j.vaccine.2022.06.071. Epub 2022 Jul 7.

    PubMed 35811205

  • Loubet P, Rouviere J, Merceron A, Launay O, Sotto A, On Behalf Of The Avnir Group. Patients' Perception and Knowledge about Influenza and Pneumococcal Vaccination during the COVID-19 Pandemic: An Online Survey in Patients at Risk of Infections. Vaccines (Basel). 2021 Nov 22;9(11):1372. doi: 10.3390/vaccines9111372.

    PubMed 34835303

  • Launay O, Le Strat Y, Tosini W, Kara L, Quelet S, Levy S, Danan J, Reveillon J, Houdayer J, Bouvet E, Levy-Bruhl D; ANRS-FORMVAC Study Group. Impact of free on-site vaccine and/or healthcare workers training on hepatitis B vaccination acceptability in high-risk subjects: a pre-post cluster randomized study. Clin Microbiol Infect. 2014 Oct;20(10):1033-9. doi: 10.1111/1469-0691.12689. Epub 2014 Jul 25.

    PubMed 24850059

  • Alessandrini V, Anselem O, Girault A, Mandelbrot L, Luton D, Launay O, Goffinet F. Does the availability of influenza vaccine at prenatal care visits and of immediate vaccination improve vaccination coverage of pregnant women? PLoS One. 2019 Aug 1;14(8):e0220705. doi: 10.1371/journal.pone.0220705. eCollection 2019.

    PubMed 31369626

  • Mohammed H, McMillan M, Roberts CT, Marshall HS. A systematic review of interventions to improve uptake of pertussis vaccination in pregnancy. PLoS One. 2019 Mar 28;14(3):e0214538. doi: 10.1371/journal.pone.0214538. eCollection 2019.

    PubMed 30921421

Questions about this trial

What is this clinical trial studying?

An observational study of Healthcare Providers and Postpartum, run by Assistance Publique - Hôpitaux de Paris at 6 sites 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 12 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie LACHATRE, MD (0033158412093, marie.lachatre@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects vaccinated against pneumococcal infections (time frame: Month 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07243236, which also lists 16 linked publications.

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 8 Apr 2026.

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