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NCT02837926 Clinical Trial

Comparing Health Services Interventions for the Prevention of HPV-related Cancer

Cervical Cancer Clinical Trial

— CoheaHr-WP4  

Official title:
Work Package 4: HPV Vaccination of Women in Screening Ages

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02837926
Other study ID # PO15019
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2016
Est. completion date June 2018

Study information
Verified date April 2019
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.

Description:

3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered.

Safety data and HPV vaccine compliance will be assessed.

A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders.

Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date June 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria:

- women within the age range of 25-45

- attending cervical cancer screening

Exclusion Criteria:

- previous history of HPV vaccine administration

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire

Biological:
• Gardasil vaccine

• Cervarix®

Locations
Country Name City State
France Chu Reims Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of vaccinated patients up to 3 years
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