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OpenTrials
Completed

NCT Number: NCT07824076

Impact of an e-Bug Educational Intervention on HPV and Meningococcal ACWY Vaccine Uptake in Middle School Students

"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."

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

e-Bug School-Based Educational Intervention

Behavioral

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.

Standard School-Based Vaccination Campaign

Behavioral

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.

Primary outcomes

  1. HPV and Meningococcal ACWY vaccination uptake (1st and 2nd doses) in the pilot school compared with departmental and region data

    Time frame: 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.

Secondary outcomes

  1. Parental consent rate (acceptability)

    Time frame: 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.

  2. Response rate (return of vaccination authorisation forms)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 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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