Status:
RECRUITING
Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
Lead Sponsor:
Miriam Elfström
Collaborating Sponsors:
Karolinska University Hospital
Conditions:
HPV Infection
CIN 2/3
Eligibility:
FEMALE
22-27 years
Phase:
PHASE4
Brief 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....
Detailed Description
In Sweden, 150 women die of and 550 women are diagnosed with cervical cancer each year. The average age at diagnosis is about 55 years and every third woman is under 40 years of age. World-wide, there...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
150000 Patients enrolled
Trial Details
Trial ID
NCT04910802
Start Date
May 3 2021
End Date
December 31 2027
Last Update
September 16 2021
Active Locations (1)
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1
Cancer prevention, screening, and counseling unit, Regional Cancer Center of Stockholm-Gotland
Stockholm, Sweden, 10239