Clinical trial · Interventional
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
NCT04910802CI-TRIAL-00053898recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil9 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV-vaccination
- description
- Women ages 22-26 will be offered concomitant vaccination (1 dose of Gardasil9) and HPV screening. A second dose of Gardasil9 will be administered 3 years later.
- interventionNames
- Biological: Gardasil9
Primary outcomes (3)
- measure
- Prevalence of HPV
- timeFrame
- Measured at recruitment.
- description
- 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.
- measure
- Prevalence of HPV
- timeFrame
- Measured 3 years after recruitment, at the second cervical screening attendance.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
- Maximum age
- 27 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDArroyo Muhr LS, Gini A, Yilmaz E, Hassan SS, Lagheden C, Hultin E, Garcia Serrano A, Ure AE, Andersson H, Merino R, Elfstrom KM, Baussano I, Dillner J. Concomitant human papillomavirus (HPV) vaccination and screening for elimination of HPV and cervical cancer. Nat Commun. 2024 May 1;15(1):3679. doi: 10.1038/s41467-024-47909-x. PMID 38693149