Trial | NCT02009800  Report issue

Title

ICI-VPH: Impact of HPV Immunisation Schedules Against HPV
ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3364
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.
Study Started
Nov 30
2013
Primary Completion
Dec 31
2021
Study Completion
Dec 31
2021
Last Update
Apr 28
2022

Biological Quadrivalent HPV vaccine

One dose of Gardasil administered in the intervention group

  • Other names: Gardasil

2 dose of quadrivalent HPV vaccine No Intervention

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.

3 doses of quadrivalent HPV vaccine Experimental

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)

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
No Results Posted