NCT02009800
Completed
Phase 3
ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV
CHU de Quebec-Universite Laval2 sites in 1 country3,364 target enrollmentNovember 2013
ConditionsHuman Papillomavirus Infections
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Human Papillomavirus Infections
- Sponsor
- CHU de Quebec-Universite Laval
- Enrollment
- 3364
- Locations
- 2
- Primary Endpoint
- Incidence of persistent HPV-16/18 infections
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Chantal Sauvageau
Co-principal investigator
CHU de Quebec-Universite Laval
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
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(5 years after recruitment visit)
Study Sites (2)
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