ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

Laval University

Status and phase: Completed; Phase 3

Conditions: Human Papillomavirus Infections

Treatments: Biological: Quadrivalent HPV vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02009800

ICI-VPH-1

Details and patient eligibility

About

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.

Enrollment: 3,364 patients

Sex: Female

Ages: 14 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

3,364 participants in 2 patient groups

2 dose of quadrivalent HPV vaccine

No Intervention group

Description:

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 group

Description:

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)

Treatment:

Biological: Quadrivalent HPV vaccine