A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine

NCT00501137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2015-04-10

No results posted yet for this study

Summary

Primary objective is to determine if antibody responses to HPV types 16 \& 18 are non-inferior after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination, with responses measured at Month 7.

Conditions

Interventions

BIOLOGICAL

HPV (Human Papillomavirus) Vaccine

HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm

Sponsors & Collaborators

  • Ministry of Health, British Columbia

    collaborator OTHER_GOV
  • Simon Dobson

    lead OTHER

Principal Investigators

  • Simon Dobson, MD · University of British Columbia

  • David Scheifele, MD · Vaccine Evaluation Centre, Vancouver

  • Meena Dawar, MD · Vaccine Evaluation Centre, Vancouver

  • Tobias Kollman, MD · Vaccine Evaluation Centre, Vancouver

  • Shelly McNeil, MD · Centre for Vaccinology, Halifax

  • Scott Halperin, MD · Centre for Vaccinology, Halifax

  • Joanne Langley, MD · Centre for Vaccinology, Halifax

  • Marc Dionne, MD · Centre de Recherche du CHUL (CHUQ), Quebec

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-02-29
Completion
2010-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT00501137 on ClinicalTrials.gov