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Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
RECRUITINGPhase 4Sponsored by Miriam Elfström
Actively Recruiting
PhasePhase 4
SponsorMiriam Elfström
Started2021-05-03
Est. completion2025-12-31
Eligibility
Age22 Years – 27 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04910802
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
Age: 22 Years – 27 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria: * 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 Criteria: 1. 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 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. 4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose 5. Current pregnancy (reported) 6. Women with a total hysterectomy
Conditions4
CIN 2/3CancerCervical CancerHPV Infection
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Actively Recruiting
PhasePhase 4
SponsorMiriam Elfström
Started2021-05-03
Est. completion2025-12-31
Eligibility
Age22 Years – 27 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04910802