RecruitingPhase 4NCT04910802
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
Sponsor
Miriam Elfström
Enrollment
150,000 participants
Start Date
May 3, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALEMin Age: 22 YearsMax Age: 27 Years
Inclusion Criteria2
- 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.
Exclusion Criteria6
- 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
- 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.
- Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
- Current pregnancy (reported)
- Women with a total hysterectomy
Interventions
BIOLOGICALGardasil9
Concomitant vaccination and HPV screening. Gardasil9 will be administered using standard dosage. 1 dose at recruitment and the 2nd dose 3 years later.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04910802
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