NCT04910802RecruitingPhase 4
Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
Concomitant HPV Vaccination and HPV Screening for Rapid Elimination of HPV Infection and Cervical Cancer in Sweden
Source: ClinicalTrials.gov · Last updated 16 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study aims to evaluate whether organised, concomitant HPV vaccination and HPV screening offered to all resident women aged 22-27 will result in a more rapid elimination of HPV infection in Sweden. This objective will be examined at the population level.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150000 (estimated)
- First submitted
- 1 May 2021
- Start date
- 3 May 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Miriam Elfström
- Diseases
- Cervical cancer
- NCT number
- NCT04910802
- EU CT number
- 2024-518857-41-00
- EudraCT number
- 2020-001169-34
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150000
- From 3 May 2021 to the primary completion date, 31 Dec 2025
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
Other illness
- Known history of immune-related disorders
- Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
Lab values
- Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine.For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate
Other
- Current pregnancy (reported)
- Women with a total hysterectomy
Who the study is looking for
- Eligible women will include resident women within the age range of 22-26, who have not opted out of the screening program and who consent to participate in the study.
- Women who respond to the invitation and attend screening will be screened with HPV testing by the current routine practise. Women who consent to participate will also be offered HPV vaccination. The HPV vaccine (Gardasil 9) will be offered regardless of whether the woman reports having had prior vaccination with a first-generation vaccine (Gardasil 4) and regardless of screening test result.
Age in the registry: 22 years to 27 years · Sex: Female · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.