Meningococcal ACWY VaccinesNCT07824076
Impact of an e-Bug Educational Intervention on HPV and Meningococcal ACWY Vaccine Uptake in Middle School Students
An observational study of Meningococcal ACWY Vaccines and HPV Coverage, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningococcal ACWY Vaccines, HPV Coverage, Meningitidis Infections
- What is being tested?
- e-Bug School-Based Educational Intervention and Standard School-Based Vaccination Campaign
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 53,608 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- No individual participants are enrolled. The study uses only aggregated, anonymised vaccination data routinely collected by ARS PACA.
Who cannot join
- Not applicable. No individual-level inclusion or exclusion criteria are defined, as no participants are enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
"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."
- Being tested
- e-Bug School-Based Educational Intervention, Standard School-Based Vaccination Campaign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Bug School-Based Educational InterventionBehavioural
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 CampaignBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard School-Based Vaccination Campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From (start of 2025 HPV and Meningococcal ACWY vaccination campaign) to (end of 2025-2026)
Secondary outcomes (2)
Parental consent rate (acceptability)
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.
Measured: One school years 2025-2026
Response rate (return of vaccination authorisation forms)
Aggregated rate of returned parental authorisation forms (regardless of response: yes/no) in the pilot school compared with departmental and region response rates.
Measured: one school years: 2025-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 May 2026
- Primary completion30 Jun 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal ACWY VaccinesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 53,608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824076
- Sponsor's protocol ID
- 26SantéMentale02
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07824076
- Acronym / sponsor ID
- 26SantéMentale02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53,608 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot School Using e-Bug Programme | – | Behavioral: e-Bug School-Based Educational InterventionThe 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 | – | Behavioral: Standard School-Based Vaccination CampaignStudents 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- No individual participants are enrolled. The study uses only aggregated, anonymised vaccination data routinely collected by ARS PACA.
Key exclusion criteria (1 listed)
- Not applicable. No individual-level inclusion or exclusion criteria are defined, as no participants are enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-Bug School-Based Educational InterventionThe 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. | Behavioural | Pilot School Using e-Bug Programme |
| Standard School-Based Vaccination CampaignStudents 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. | Behavioural | Other Middle Schools in Alpes-Maritimes Department and PACA region |
Primary outcome
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.
2 secondary outcomes
Parental consent rate (acceptability)
Time frame: One school years 2025-2026
Response rate (return of vaccination authorisation forms)
Time frame: one school years: 2025-2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningococcal ACWY Vaccines and HPV Coverage, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.