ICI-VPH: Impact of HPV Immunisation Schedules Against HPV
Phase 3
Completed
- Conditions
- Human Papillomavirus Infections
- Registration Number
- NCT02009800
- Lead Sponsor
- CHU de Quebec-Universite Laval
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3364
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of persistent HPV-16/18 infections 5 years after recruitment visite
- Secondary Outcome Measures
Name Time Method Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18 5 years after recruitment visit
Trial Locations
- Locations (2)
Centre Hospitalier Uiversitaire de Montréal
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier Universitaire de Québec, CHU de Québec
🇨🇦Québec, Canada
Centre Hospitalier Uiversitaire de Montréal🇨🇦Montréal, Quebec, Canada