premaligne genitale laesies (cervicaal, vulvair en vaginaal) en genitale wratten (condylomata acuminata) HPV infection and disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine uptake is the primary parameter for this study. This will be estimated as the percentage of women who get at least one dose of HPV vaccine among all of those who fill the questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaccine compliance of one, two or three doses is the secondary study parameter. | — |
Countries
Netherlands