Study in several countries to asess the proportion of adult women (30-45 years) WHO accept to receive the HPV vaccine, the reasons to accept it and how many of these women who receive three doses of the vaccine.
- Conditions
- Cervical cancerMedDRA version: 19.0 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864MedDRA version: 19.0 Level: LLT Classification code 10056576 Term: Cervical intraepithelial neoplasia System Organ Class: 100000004872Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003177-42-DK
- Lead Sponsor
- Catalan Institute of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 3250
Adult women aged 30-45 years attending routine cervical cancer screening with no previous history of HPV vaccine administration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3250
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Women with a known history of severe allergic reaction or hypersensitivity to any of the components of the vaccine.
- Women with a known history of immune-related disorders.
- Women with current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever. When recovered, the vaccine can be administered.
- Pregnant women, women planning to get pregnant in the coming 12 months, and women who are breastfeeding
- Hysterectomized women
- Administration of immunoglobulin or blood-derived products within 6 months prior to the first HPV dose
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The main objectives of the study are:<br> - to assess the uptake and identify the determinants of acceptability of HPV vaccination by women aged 30-45 years attending routine cervical cancer screening <br> - to identify logistic and programmatic issues associated with HPV vaccination of adult women, such as which information should be provided to women that are offered the vaccine and how should the information be offered<br> ;<br> Secondary Objective: Secondary objectives of the study include:<br> - estimation of compliance with 1-, 2- and 3- doses of the HPV vaccine<br> - monitoring of adverse effects of the HPV vaccine in the targeted population<br> ;Primary end point(s): Uptake of HPV vaccine in eligible women, by country and age starte;Timepoint(s) of evaluation of this end point: End of the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Compliance with HPV vaccine administration schedule;Timepoint(s) of evaluation of this end point: End of the study