Comparing Health Services Interventions for the Prevention of HPV-related Cancer (CoheaHr-WP4)
|ClinicalTrials.gov Identifier: NCT02837926|
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Other: questionnaire Biological: Gardasil vaccine Biological: Cervarix®||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Work Package 4: HPV Vaccination of Women in Screening Ages|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||June 2018|
|Experimental: women attending for cervical cancer screening||
Biological: Gardasil vaccine
- number of vaccinated patients [ Time Frame: up to 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837926
|Reims, France, 51092|