MedTrace Logo

ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

NCT02009800 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3364

Last updated 2022-04-28

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus Infections

Interventions

BIOLOGICAL

Quadrivalent HPV vaccine

One dose of Gardasil administered in the intervention group

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    collaborator OTHER

  • Ministere de la Sante et des Services Sociaux

    collaborator OTHER

  • Institut National en Santé Publique du Québec

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009800 on ClinicalTrials.gov