CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,364 enrolled
Drug / intervention
Quadrivalent HPV vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02009800
NCT02009800Phase 3Completed
CompareCT.gov

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

CHU de Quebec-Universite Laval·interventional·Posted Dec 12, 2013·Updated Apr 28, 2022

In Brief

A Phase 3 clinical trial evaluating Quadrivalent HPV vaccine for Human Papillomavirus Infections. Completed, enrolled 3,364 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Papillomavirus Infections
CountriesCanada
CollaboratorsCentre hospitalier de l'Université de Montréal (CHUM), Ministere de la Sante et des Services Sociaux, Institut National en Santé Publique du Québec

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 12, 2013
Enrollment StartNov 1, 2013
Primary CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 12.6 years ago

Interventions

Quadrivalent HPV vaccinebiological

One dose of Gardasil administered in the intervention group