ICI-VPH: Impact of HPV Immunisation Schedules Against HPV (ICI-VPH)
Primary Purpose
Human Papillomavirus Infections
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Quadrivalent HPV vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Human Papillomavirus Infections
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Uiversitaire de Montréal
- Centre Hospitalier Universitaire de Québec, CHU de Québec
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
2 dose of quadrivalent HPV vaccine
3 doses of quadrivalent HPV vaccine
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
Incidence of persistent HPV-16/18 infections
Secondary Outcome Measures
Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18
Full Information
NCT ID
NCT02009800
First Posted
December 9, 2013
Last Updated
April 21, 2022
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM), Ministere de la Sante et des Services Sociaux, Institut National en Santé Publique du Québec
1. Study Identification
Unique Protocol Identification Number
NCT02009800
Brief Title
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV
Acronym
ICI-VPH
Official Title
ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM), Ministere de la Sante et des Services Sociaux, Institut National en Santé Publique du Québec
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3364 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 dose of quadrivalent HPV vaccine
Arm Type
No Intervention
Arm Description
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.
Arm Title
3 doses of quadrivalent HPV vaccine
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
Quadrivalent HPV vaccine
Other Intervention Name(s)
Gardasil
Intervention Description
One dose of Gardasil administered in the intervention group
Primary Outcome Measure Information:
Title
Incidence of persistent HPV-16/18 infections
Time Frame
5 years after recruitment visite
Secondary Outcome Measure Information:
Title
Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18
Time Frame
5 years after recruitment visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Uiversitaire de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Québec, CHU de Québec
City
Québec
ZIP/Postal Code
G1R 2J6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV
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