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Comparing Health Services Interventions for the Prevention of HPV-related Cancer (CoheaHr-WP4)

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ClinicalTrials.gov Identifier: NCT02837926
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Other: questionnaire Biological: Gardasil vaccine Biological: Cervarix® Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: women attending for cervical cancer screening Other: questionnaire
Biological: Gardasil vaccine
Biological: Cervarix®



Primary Outcome Measures :
  1. number of vaccinated patients [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women within the age range of 25-45
  • attending cervical cancer screening

Exclusion Criteria:

  • previous history of HPV vaccine administration

Information from the National Library of Medicine

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


Locations
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France
Chu Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02837926     History of Changes
Other Study ID Numbers: PO15019
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female