ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

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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Key information

Conditions

Human Papillomavirus Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

14 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Uiversitaire de Montréal, Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadrivalent HPV Vaccine

Biological

One dose of Gardasil administered in the intervention group

Other names: Gardasil

Primary outcomes

Incidence of persistent HPV-16/18 infections

Time frame: 5 years after recruitment visite

Secondary outcomes

Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18

Time frame: 5 years after recruitment visit

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)
Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux

Registry information

Official study title

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

Acronym: ICI-VPH

Important dates

Study start: 2013
Primary completion: 2021
Study completion: 2021
First posted: Dec 12, 2013
Registry last updated: Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed