Comparing Health Services Interventions for the Prevention of HPV-related Cancer (CoheaHr-WP4)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837926
|Reims, France, 51092|