- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07824076
Impact of an e-Bug Educational Intervention on HPV and Meningococcal ACWY Vaccine Uptake in Middle School Students
Pilot Observational Comparative Study Evaluating the Impact of the e-Bug Educational Programme on Parental Consent and HPV and Meningococcal ACWY Vaccination Coverage During the National School-Based Vaccination Campaign in a Middle School in the Alpes-Maritimes Department and PACA Region
"This study is a non-interventional observational pilot analysis assessing the possible impact of an educational programme (e-Bug) on parental consent and HPV and meningococcal ACWY vaccination uptake during the 2025-2026 national school-based vaccination campaigns in France. The study focuses on one middle school in the Alpes-Maritimes department and PACA region where teachers and the school nurse had been previously trained on vaccination and used e-Bug educational resources in class as part of routine health education. No research-related intervention was conducted, and the educational programme was not introduced or modified for the purpose of the study.
Only aggregated and anonymised vaccination data were used. These data were routinely collected by the Regional Health Agency (ARS PACA) as part of the national vaccination programme and transmitted for analysis. Aggregated data from the pilot school were compared with departmental-level outcomes to describe whether an upstream educational approach may be associated with improved parental acceptance and higher hpv and meningococcal acwy vaccination coverage. This study aims to contribute to the understanding of educational determinants of vaccine uptake in a real-life school setting without involving any participant recruitment or individual data collection."
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alpes Maritimes
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Nice, Alpes Maritimes, Francia, 06000
- Chu De Nice
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- No individual participants are enrolled. The study uses only aggregated, anonymised vaccination data routinely collected by ARS PACA.
Exclusion Criteria:
- Not applicable. No individual-level inclusion or exclusion criteria are defined, as no participants are enrolled.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Pilot School Using e-Bug Programme
The intervention consisted of a school-based educational programme implemented before the national vaccination campaign using MenACWY-specific e-Bug educational resources.
Age-appropriate classroom activities addressed meningococcal disease, transmission, disease severity, prevention, and vaccination.
The intervention also involved close collaboration between teachers and the school nurse, communication with families, and active follow-up of non-responding parents.
|
The intervention consisted of a school-based educational programme implemented before the national vaccination campaign using MenACWY-specific e-Bug educational resources.
Age-appropriate classroom activities addressed meningococcal disease, transmission, disease severity, prevention, and vaccination.
The intervention also involved close collaboration between teachers and the school nurse, communication with families, and active follow-up of non-responding parents.
|
|
Other Middle Schools in Alpes-Maritimes Department and PACA region
Students participated in the national school-based vaccination campaign and received the standard information materials provided as part of the campaign.
No MenACWY-specific e-Bug educational intervention was implemented in these schools during the study period.
|
Students participated in the national school-based vaccination campaign and received the standard information materials provided as part of the campaign.
No MenACWY-specific e-Bug educational intervention was implemented in these schools during the study period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
HPV and Meningococcal ACWY vaccination uptake (1st and 2nd doses) in the pilot school compared with departmental and region data
Periodo de tiempo: From (start of 2025 HPV and Meningococcal ACWY vaccination campaign) to (end of 2025-2026)
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Aggregated rates of HPV and Meningococcal ACWY vaccination uptake (first and second doses) among 5th-grade students in the pilot middle school using the e-Bug educational programme, compared with aggregated departmental and region vaccination rates from all other middle schools in the PACA area.
|
From (start of 2025 HPV and Meningococcal ACWY vaccination campaign) to (end of 2025-2026)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parental consent rate (acceptability)
Periodo de tiempo: One school years 2025-2026
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Aggregated proportion of parents providing positive consent for HPV and Meningococcal ACWY vaccination in the pilot school, compared with aggregated departmental and region consent rates collected by ARS PACA during the 2025-2026 school-based campaigns.
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One school years 2025-2026
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Response rate (return of vaccination authorisation forms)
Periodo de tiempo: one school years: 2025-2026
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Aggregated rate of returned parental authorisation forms (regardless of response: yes/no) in the pilot school compared with departmental and region response rates.
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one school years: 2025-2026
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 26SantéMentale02
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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