ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

Phase 3CompletedNCT02009800

CHU de Quebec-Universite Laval3,364 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

3,364

Conditions

Human Papillomavirus Infections

Interventions

Quadrivalent HPV vaccineBIOLOGICAL

One dose of Gardasil administered in the intervention group

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Centre Hospitalier Uiversitaire de Montréal

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Québec, CHU de Québec

Québec, Canada

Outcomes

Primary Outcomes

Incidence of persistent HPV-16/18 infections

Time frame: 5 years after recruitment visite

Secondary Outcomes

Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18

Time frame: 5 years after recruitment visit

Data from ClinicalTrials.gov

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