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NCT05462249 Clinical Trial

Impact of Catch-up HPV Vaccination

Cervical Cancer Clinical Trial

— HPVAC2  

Official title:
Impact of Catch-up HPV Vaccination on the Development of Cervical Lesions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05462249
Other study ID # HPVAC2 - 29BRC21.0008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 21, 2021
Est. completion date June 30, 2022

Study information
Verified date September 2022
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 354
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 38 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU de BREST Brest Finistère

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Test HPV and smear test result. Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old). 13 months.
Secondary Test HPV and smear test result. Study the effectiveness of anti-HPV vaccine (done between 11 and 15 years old). 13 months.
Secondary Test HPV and smear test result. Study the effectiveness of anti-HPV vaccine (not regarding the period of realization) 13 months.
Secondary Test HPV and smear test result. Compare the effectiveness of anti-HPV vaccine done before and after 15 years old. 13 months.
Secondary Test HPV and smear test result regarding the cervical cancer risk factors. Study the impact of the known cervical cancer risk factors on the smear results. 13 months.
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