Human Papillomavirus Infections
Conditions
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.
Interventions
BIOLOGICALQuadrivalent HPV vaccine
One dose of Gardasil administered in the intervention group
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Ministere de la Sante et des Services Sociaux
Institut National en Santé Publique du Québec
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of persistent HPV-16/18 infections | 5 years after recruitment visite |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18 | 5 years after recruitment visit |
Countries
Canada
Outcome results
None listed