- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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."
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Alpes Maritimes
-
Nice, Alpes Maritimes, Frankrike, 06000
- Chu De Nice
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HPV and Meningococcal ACWY vaccination uptake (1st and 2nd doses) in the pilot school compared with departmental and region data
Tidsramme: From (start of 2025 HPV and Meningococcal ACWY vaccination campaign) to (end of 2025-2026)
|
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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parental consent rate (acceptability)
Tidsramme: One school years 2025-2026
|
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.
|
One school years 2025-2026
|
|
Response rate (return of vaccination authorisation forms)
Tidsramme: one school years: 2025-2026
|
Aggregated rate of returned parental authorisation forms (regardless of response: yes/no) in the pilot school compared with departmental and region response rates.
|
one school years: 2025-2026
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 26SantéMentale02
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .