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
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
- Cervical Cancer
- Genital Warts
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
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