Clinical trial · Interventional
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV
ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV
- 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)
This randomised clinical trial aims to determine whether an immunization schedule comprising two doses of Gardasil administered six months apart is non-inferior to a schedule comprising three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18 infections that persist for at least six months, up to ten years after the initial vaccination. The study hypothesis is that the two-dose schedule would offer similar protection as that of a three-dose schedule against persistent HPV-16/18 infections.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quadrivalent HPV vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- 2 dose of quadrivalent HPV vaccine
- description
- The participants who have already received 2 doses of the quadrivalent HPV vaccine (0, 6 months schedule) 5 years before recruitment will not receive an additional dose.
- type
- EXPERIMENTAL
- label
- 3 doses of quadrivalent HPV vaccine
- description
- The participants will receive a 3rd dose of quadrivalent HPV vaccine at recruitment visit, which is 5 years after having received two doses of vaccine given 6 months apart in grade 4 (0, 6, 60 months Schedule)
- interventionNames
- Biological: Quadrivalent HPV vaccine
Primary outcomes (1)
- measure
- Incidence of persistent HPV-16/18 infections
- timeFrame
- 5 years after recruitment visite
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 14 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Having received two doses of Gardasil in 2008-2009, 2009-2010,2010-2011 or 2011-2012 according to 0, 6 months Schedule (between 4 and 12 months) * Resident of the regions chosen for the study Exclusion Criteria: * Being considered immunosuppressed at time of vaccination (9-10 years-old) or at recruitment visit * Being pregnant at recruitment visit
References
Publications (2)
- DERIVEDBergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. PMID 41276263
- DERIVEDSauvageau C, Mayrand MH, Ouakki M, Ionescu IG, Coutlee F, Lacaille J, Benoit M, Gilca V. Protection Against Persistent HPV-16/18 Infection After Different Number of Doses of Quadrivalent Vaccine in Girls and Young Women: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519095. doi: 10.1001/jamanetworkopen.2025.19095. PMID 40627355