NCT04910802 Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
| NCT ID | NCT04910802 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Miriam Elfström |
| Condition | HPV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 150,000 participants |
| Start Date | 2021-05-03 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150,000 participants in total. It began in 2021-05-03 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. This objective will be examined at the population level.
Eligibility Criteria
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
Contact & Investigator
Joakim Dillner, MD, PhD
STUDY DIRECTOR
Karolinska University Hospital Laboratory
Frequently Asked Questions
Who can join the NCT04910802 clinical trial?
This trial is open to female participants only, aged 22 Years or older, up to 27 Years, studying HPV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04910802 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04910802 currently recruiting?
Yes, NCT04910802 is actively recruiting participants. Contact the research team at miriam.elfstrom@sll.se for enrollment information.
Where is the NCT04910802 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT04910802 clinical trial?
NCT04910802 is sponsored by Miriam Elfström. The principal investigator is Joakim Dillner, MD, PhD at Karolinska University Hospital Laboratory. The trial plans to enroll 150,000 participants.