Study in several countries to asess the proportion of adult women (25-45 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 cancerTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10056576 Term: Cervical intraepithelial neoplasia System Organ Class: 100000004872
- Registration Number
- EUCTR2014-003177-42-SE
- 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 25-45 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
- Secondary Outcome Measures
Name Time Method