Study in several countries to asess the proportion of adult women (30-45 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.

Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 30 to 45 years

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003177-42-DK

Enrollment

3250

Registered

2014-10-01

Start date

2014-10-10

Completion date

Unknown

Last updated

2019-12-16

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

Conditions

Cervical cancer MedDRA version: 19.0 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864 MedDRA version: 19.0 Level: LLT Classification code 10056576 Term: Cervical intraepithelial neoplasia System Organ Class: 100000004872

Interventions

Trade Name: Gardasil Pharmaceutical Form: Suspension for injection INN or Proposed INN: HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult women aged 30-45 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objectives of the study are: - to assess the uptake and identify the determinants of acceptability of HPV vaccination by women aged 30-45 years attending routine cervical cancer screening - to identify logistic and programmatic issues associated with HPV vaccination of adult women, such as which information should be provided to women that are offered the vaccine and how should the information be offered ; Secondary Objective: Secondary objectives of the study include: - estimation of compliance with 1-, 2- and 3- doses of the HPV vaccine - monitoring of adverse effects of the HPV vaccine in the targeted population ;Primary end point(s): Uptake of HPV vaccine in eligible women, by country and age starte;Timepoint(s) of evaluation of this end point: End of the study	—

Measure

Time frame

Main Objective: The main objectives of the study are: - to assess the uptake and identify the determinants of acceptability of HPV vaccination by women aged 30-45 years attending routine cervical cancer screening - to identify logistic and programmatic issues associated with HPV vaccination of adult women, such as which information should be provided to women that are offered the vaccine and how should the information be offered ; Secondary Objective: Secondary objectives of the study include: - estimation of compliance with 1-, 2- and 3- doses of the HPV vaccine - monitoring of adverse effects of the HPV vaccine in the targeted population ;Primary end point(s): Uptake of HPV vaccine in eligible women, by country and age starte;Timepoint(s) of evaluation of this end point: End of the study

—

Secondary

Measure	Time frame
Secondary end point(s): Compliance with HPV vaccine administration schedule;Timepoint(s) of evaluation of this end point: End of the study	—

Countries

Belgium, Denmark, Finland, Netherlands, Slovenia, Spain, Sweden

Contacts

Public ContactCoheaHr - WP4 contact person

Catalan Institute of Oncology

coheahr-wp4@hpvcentre.net+34932607812

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026