ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Papillomavirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2 dose of quadrivalent HPV vaccine

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

3 doses of quadrivalent HPV vaccine

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)

Group Type EXPERIMENTAL

Quadrivalent HPV vaccine

Intervention Type BIOLOGICAL

One dose of Gardasil administered in the intervention group

Interventions

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Quadrivalent HPV vaccine

One dose of Gardasil administered in the intervention group

Intervention Type BIOLOGICAL

Other Intervention Names

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Gardasil

Eligibility Criteria

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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