drugset / Trial / NCT02009800
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV
Phase 3
Completed
3364 enrolled
CHU de Quebec-Universite Laval
Centre hospitalier de l'Université de Montréal (CHUM) · collabInstitut National en Santé Publique du Québec · collabMinistere de la Sante et des Services Sociaux · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
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.
Timeline
- Start
- 2013-11
- Primary completion
- 2021-12
- Completion
- 2021-12
Publications
- Bergman 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.
- Sauvageau 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gardasil | Vaccine | — | — |