NCT02009800

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,364

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

8.1 years

First QC Date

December 9, 2013

Last Update Submit

April 21, 2022

Conditions

Human Papillomavirus Infections

Outcome Measures

Primary Outcomes (1)

  • Incidence of persistent HPV-16/18 infections

    5 years after recruitment visite

Secondary Outcomes (1)

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

    5 years after recruitment visit

Study Arms (2)

2 dose of quadrivalent HPV vaccine

NO INTERVENTION

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.

3 doses of quadrivalent HPV vaccine

EXPERIMENTAL

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)

Biological: Quadrivalent HPV vaccine

Interventions

Quadrivalent HPV vaccineBIOLOGICAL

One dose of Gardasil administered in the intervention group

Also known as: Gardasil
3 doses of quadrivalent HPV vaccine

Eligibility Criteria

Age14 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Being considered immunosuppressed at time of vaccination (9-10 years-old) or at recruitment visit
  • Being pregnant at recruitment visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Uiversitaire de Montréal

Montreal, Quebec, H2W 1T8, Canada

Location

Centre Hospitalier Universitaire de Québec, CHU de Québec

Québec, G1R 2J6, Canada

Location

Related Publications (2)

  • 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.

    PMID: 41276263DERIVED

  • 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.

    PMID: 40627355DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-principal investigator

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

CA(2)