Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years
- Conditions
- premaligne genitale laesies (cervicaal, vulvair en vaginaal) en genitale wratten (condylomata acuminata)HPV infection and disease1004743810038594
- Registration Number
- NL-OMON44098
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 250
1) Female aged 30-45 years
2) Participated in the national screening program for cervical cancer in 2015
3) No previous history of HPV vaccine administration.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1) Known history of severe allergic reaction or hypersensitivty to any of the components of Cervarix: Sodium chloride (NaCl), Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O), AS04: 3-O-desacyl-4*- monophosphoryl lipid A (MPL) or Aluminium hydroxide (Al(OH)3)
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Vaccine uptake is the primary parameter for this study. This will be estimated<br /><br>as the percentage of women who get at least one dose of HPV vaccine among all<br /><br>of those who fill the questionnaire. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Vaccine compliance of one, two or three doses is the secondary study parameter.</p><br>