A Phase 3 interventional study of Quadrivalent HPV vaccine in Human Papillomavirus Infections, sponsored by CHU de Quebec-Universite Laval. Completed at 2 sites in Canada. Open to female participants aged 14 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by CHU de Quebec-Universite Laval · Phase 3, Interventional, and Prevention
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.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 3,364 is above the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Biological: Quadrivalent HPV vaccine
One dose of Gardasil administered in the intervention group
Also known as: Gardasil
Incidence of persistent HPV-16/18 infections
Time frame: 5 years after recruitment visite
Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18
Time frame: 5 years after recruitment visit
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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CHU de Quebec-Universite Laval