NCT07824076

Brief Summary

"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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53,608

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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)

Secondary Outcomes (2)

  • Parental consent rate (acceptability)

    One school years 2025-2026

  • Response rate (return of vaccination authorisation forms)

    one school years: 2025-2026

Study Arms (2)

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.

Behavioral: e-Bug School-Based Educational Intervention

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.

Behavioral: Standard School-Based Vaccination Campaign

Interventions

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.

Pilot School Using e-Bug Programme

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.

Other Middle Schools in Alpes-Maritimes Department and PACA region

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Aggregated data from 5th-grade students enrolled in one pilot middle school using the e-Bug programme, compared with aggregated data from all other middle schools in the Alpes-Maritimes department and PACA region. No individual-level data were accessed.

You may qualify if:

  • No individual participants are enrolled. The study uses only aggregated, anonymised vaccination data routinely collected by ARS PACA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Location

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start

May 1, 2026

Primary Completion

June 30, 2026

Study Completion

September 1, 2026

Last Updated

September 17, 2026

Record last verified: 2026-09

Locations