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Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years

Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years - CoheaHr-WP4

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44098
Enrollment
250
Registered
2016-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

premaligne genitale laesies (cervicaal, vulvair en vaginaal) en genitale wratten (condylomata acuminata) HPV infection and disease

Interventions

All patients are invited for HPV vaccination with Cervarix. This is optional.

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime frame
Vaccine compliance of one, two or three doses is the secondary study parameter.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)