Study in several countries to assess the proportion of adult women (25-45 yrs) who accept to receive the HPV vaccine, the reasons to accept it and how many of these women receive the three doses and why.
- Conditions
- Cervical cancerMedDRA version: 19.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 19.1Level: LLTClassification code 10056576Term: Cervical intraepithelial neoplasiaSystem Organ Class: 100000004872
- Registration Number
- EUCTR2014-003177-42-FI
- Lead Sponsor
- Catalan Institute of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 3648
Adult women within the age range of 25-45 attending cervical cancer screening with no previous history of HPV vaccine administration.
In Spain, also, women aged 35-45 yrs old with no screening record in the preceding 5 years
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 0
1. Known history of severe allergic reaction or hypersensitivty to any of the components of the HPV vaccines.
2. Known history of immune-related disorders
3. 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
4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
5. Current pregnancy (reported), breast-feeding or planning to get pregnant in the coming 12 months.
6. Hysterectomized women
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