NCT02009800

ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,364 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 14 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Papillomavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent HPV vaccine	One dose of Gardasil administered in the intervention group

Timeline

• Start date: 2013-11-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2013-12-12
• Last updated: 2022-04-28

Locations

2 sites across 1 country: Canada