ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

Human Papillomavirus Infections Clinical Trial

— ICI-VPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009800
• Other study ID #: ICI-VPH-1
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: December 2021

Study information

• Verified date: April 2022
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3364
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Infections
• Papillomavirus Infections

Intervention

Biological:
• Quadrivalent HPV vaccine
One dose of Gardasil administered in the intervention group

Locations

Country	Name	City	State
Canada	Centre Hospitalier Uiversitaire de Montréal	Montréal	Quebec
Canada	Centre Hospitalier Universitaire de Québec, CHU de Québec	Québec

Sponsors (4)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Centre hospitalier de l'Université de Montréal (CHUM), Institut National en Santé Publique du Québec, Ministere de la Sante et des Services Sociaux

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of persistent HPV-16/18 infections		5 years after recruitment visite
Secondary	Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18		5 years after recruitment visit