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“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””: Coronavirus – COVID-19
NewsRx COVID-19 Daily
2025 DEC 08 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT07243236 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | 2025-11 |
| Current Primary Outcome Measures | •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 |
| •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 |
|
| •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 |
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| •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 |
|
| Current Secondary Outcome Measures | •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.), |
| •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.), | |
| •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 | |
| •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 | |
| •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 | |
| •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 | |
| •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 | |
| •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 | |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT07243236 |
Descriptive Information
| Brief Title | Impact of Vaccine Funding by the |
| Official Title | “Assessment of the Impact of Vaccine Funding by the |
| Brief 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- |
| 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 |
| Study Type | OBSERVATIONAL |
| Study Phase | Not Provided |
| Study Design | Observational Model: COHORT |
| Time Perspective: PROSPECTIVE | |
| Condition | |
| Postpartum | |
| Intervention | •OTHER: Questionnaires for patients |
| Questionnaires for patients | |
| •OTHER: Questionnaires for healthcare providers | |
| Questionnaires for healthcare providers | |
| Study Arms | •Healthcare providers |
| Vaccinating healthcare providers + Other healthcare providers involved in the operational aspects of the project (excluding health data) | |
| Interventions: | |
| ⚬OTHER: Questionnaires for healthcare providers | |
| •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 | |
| Interventions: | |
| ⚬OTHER: Questionnaires for patients | |
| •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 |
|
| Interventions: | |
| ⚬OTHER: Questionnaires for patients | |
| Publications* | *Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline |
| PubMed Link - 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 |
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| PubMed Link - Schnell D, Mayaux J, de Bazelaire C, Legoff J, Feuillet S, Scieux C, |
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| PubMed Link - 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 |
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| PubMed Link - 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 Link - 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, |
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| PubMed Link - 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 - |
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| PubMed Link - 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 Link - Tubiana S, Belchior E, Guillot S, Guiso N, |
|
| PubMed Link - 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 |
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| PubMed Link - Del |
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| PubMed Link - Wyplosz B, Fernandes J, Sultan A, |
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| PubMed Link - Loubet P, Rouviere J, Merceron A, Launay O, Sotto A, On Behalf Of |
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| PubMed Link - Launay O, Le Strat Y, Tosini W, Kara L, Quelet S, Levy S, Danan J, Reveillon J, Houdayer J, Bouvet E, |
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| PubMed Link - 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 |
|
| PubMed Link - 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 Link - Du P, Jin S, Lu S, Wang L, Ma X, Wang J, Huang R, Luo Q, Yang S, Feng X. Strategies to increase the coverage of influenza and pneumonia vaccination in older adults: a systematic review and network meta-analysis. Age Ageing. 2024 |
Recruitment Information
| Recruitment Status | NOT_YET_RECRUITING |
| Enrollment | 2920 |
| Completion Date | 2027-07 |
| Primary Completion Date | |
| Eligibility | 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). |
| Sex/Gender | Sexes Eligible for Study: ALL |
| Ages | 18 years to |
| t | |
| Contacts | Primary contact: Marie LACHATRE, MD, 0033158412093, [email protected] |
| Backup contact: Marie BENHAMMANI-GODARD, 0033158411190, [email protected] | |
| Listed Location Countries | |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT07243236 |
| Other Study ID Numbers | 2025-A01886-43 |
| APHP251228 | |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data | Not Provided |
| Plan to Share Data (IPD) Description | Not Provided |
| Collaborators | ⚬Agence regionale de sante Ile de |
| ⚬Institut de Recherche en Sante Publique, |
|
| Investigators | STUDY_DIRECTOR: Marie LACHATRE, MD, Hopital Cochin - APHP |
| STUDY_CHAIR: Muriel BELIAH-NAPPEZ, MD, Agence regionale de sante Ile de |
|
| Information Provided By | Assistance Publique - Hopitaux de |
| Verification Date | 2025-10 |
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