A Phase 4 interventional study of questionnaire and Gardasil vaccine in Cervical Cancer, sponsored by CHU de Reims. Completed at 1 site in France. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by CHU de Reims · Phase 4, Interventional, and Prevention
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 63 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: questionnaire · Biological: Gardasil vaccine · Biological: Cervarix®
number of vaccinated patients
Time frame: up to 3 years
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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CHU de Reims