Impact of Catch-up HPV Vaccination | NCT05462249

Studies
Impact of Catch-up HPV Vaccination

NCT05462249

Sponsor

University Hospital, Brest

Status

Terminated

Last Update Posted

Apr 30, 2025Actual

Enrollment

354Actual

Phase

Not provided

Conditions

HPV
HPV Vaccination
Vaccine Preventable Disease
Cervical Lesion
Cervical Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

overestimation of the number of healthcare professionals participating in the inclusions

Expanded Access Info

Start Date

May 21, 2021Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Jul 7, 2022

First Submission Date that Met QC Criteria

Jul 13, 2022

First Posted Date

Jul 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2025

Last Update Posted Date

Apr 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Each year in France, more than 6000 new cases of HPV inducted cancers are recorded. The vaccinal cover stays insufficient since less than 30% of the french population is vaccinated. Therefore french studies about vaccine efficacy and especially about the catch-up vaccine (done after 15years old) are needed.

HPVAC2 is a prospective, analytic and monocentric study designed to learn the impact of the catch-up HPV vaccination.

Women from 25 years old and born after 1984 may be included if they come to the Brest CHU to do their regular cervical smear. At this time, a survey will be given to know their vaccinal status.

The aim of the study is to prove the efficacy of the catch up vaccination by analyzing the cervical smears results and by comparing the vaccinated group with the not-vaccinated group.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

354Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccinated		Patients who have been vaccinated against HPV virus.
Not vaccinated		Patients who have not been vaccinated against HPV virus.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Test HPV and smear test result.	Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old).	13 months.

Secondary Outcomes

Measure	Description	Time Frame
Test HPV and smear test result.	Study the effectiveness of anti-HPV vaccine (done between 11 and 15 years old).	13 months.
Test HPV and smear test result.	Study the effectiveness of anti-HPV vaccine (not regarding the period of realization)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age limit
Patient must have done a HPV or smear test during the study period
Consent necessary

Exclusion Criteria:

Age limit
No HPV or smear test done in the study period
Patient not able to give her consent

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Women between 25 and 38 years old in 2022 coming for a HPV or smear test during the study period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe MERVIEL, PU-PH	Head of the gynecologic department in Brest Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de BREST		Brest	Finistère	29000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

All the data are anonymized.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000079263	Vaccine-Preventable Diseases
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D007239	Infections
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided