Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age22-27
SponsorMiriam Elfström
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Gardasil9
Biological/VaccineConcomitant vaccination and HPV screening. Gardasil9 will be administered using standard dosage. 1 dose at recruitment and the 2nd dose 3 years later.
Treatment groups
150,000 Participants
are divided into 1 treatment groupGroup A: HPV-vaccinationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Time frame
Measured at recruitment.2
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Time frame
Measured 3 years after recruitment, at the second cervical screening attendance.3
Prevalence of HPV
Overall and type-specific prevalence of HPV will be obtained from the routine HPV screening programs in the regions that offer HPV screening to this age group.
Time frame
Measure 6 years after recruitment, at the third cervical screening attendance.Secondary outcomes
1
Number of women with histopathologically confirmed cervical intraepithelial neoplasia grade 2, 3, or cervical cancer (CIN2+)
CIN2+ measured through registry linkages, by HPV type in the lesion.
Time frame
Measured at recruitment, and subsequently at 3 year intervals.2
Consumption of resources
Number of screening and treatment visits.
Time frame
Measured at recruitment, and subsequently at 3 year intervals.3
Number of women with obstetrical complications
Obstetrical complications such as preterm births measured through registry linkages.
Time frame
Measured at recruitment, and subsequently at 3 year intervals.4
Number of women with cervical specimens found to be benign
Treatments for cervical abnormalities, measured as excised cervical specimens, found to be benign. Measured through registry linkages.
Time frame
Measured at recruitment, and subsequently at 3 year intervals.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Miriam Elfström
Lead sponsor
Region Stockholm
Sponsor institution
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov