NCT02837926

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

Work Package 4: HPV Vaccination of Women in Screening Ages

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: CHU de Reims · Academic / Other
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
OTHER	questionnaire
BIOLOGICAL	Gardasil vaccine
BIOLOGICAL	Cervarix®

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2016-07-20
• Last updated: 2019-04-10

Locations

1 site across 1 country: France