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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, British Columbia
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00501137
First received: July 11, 2007
Last updated: February 18, 2008
Last verified: February 2008
History of Changes

July 11, 2007
February 18, 2008
July 2007
February 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00501137 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine

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.

Human Papillomavirus (HPV) infection is a cause of cervical cancer. Immunogenicity, safety and efficacy in the prevention of persistent infection from HPV 16 and 18 has been proven using a 3-dose regimen in adolescent and adult females using the Quadrivalent Human Papillomavirus (Q-HPV) vaccine. The intensity of the immune response is inversely proportional to age. Immunogenicity in adolescents 9-15 years of age is 1.7 - 2 times greater than in 16-26 year old vaccine recipients. Paediatric dosing studies are necessary and prudent given limited provincial funding for new biologics acquisition and programme service delivery. A reduction from an adult 3-dose HPV vaccine regimen to a pediatric 2-dose regimen will result in increased compliance to the full vaccine series and in significant savings to the health care system both in the cost of biologics and of program delivery and administration.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Cervical Cancer
  • Genital Warts
Biological: HPV (Human Papillomavirus) Vaccine
Not Provided
Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, Sauvageau C, Scheifele DW, Kollmann TR, Halperin SA, Langley JM, Bettinger JA, Singer J, Money D, Miller D, Naus M, Marra F, Young E. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013 May 1;309(17):1793-802. doi: 10.1001/jama.2013.1625.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
830
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A female between, and including, 9-13 years (before 14th birthday) and 16-26 years of age (before 27th birthday) at the time of the first vaccination.
  • Healthy
  • Not pregnant
  • Four or less sexual partners over lifetime as reported by subject. (Sexual activity is defined as intercourse)
  • Not planning to become pregnant or likely to become pregnant
  • No reported history of genital warts
  • No laboratory confirmed history of cervical intraepithelial neoplasia
  • No previous vaccination against HPV
  • No administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
  • No previous anaphylactic reaction to HPV vaccine or any vaccine related component including aluminum hydroxyphosphate sulfate and polysorbate 80
  • No confirmed or suspected immunosuppressive or immunodeficient condition based on medical history
  • No bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • Cannot be already enrolled in any clinical trial in which investigational vaccine or drug are being administered
Female
9 Years to 26 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00501137
H07-00928, BCGov-01
Yes
Dr. Simon Dobson, University of British Columbia
University of British Columbia
Ministry of Health, British Columbia
Principal Investigator: Simon Dobson, MD University of British Columbia
Study Director: David Scheifele, MD Vaccine Evaluation Centre, Vancouver
Study Director: Meena Dawar, MD Vaccine Evaluation Centre, Vancouver
Study Director: Tobias Kollman, MD Vaccine Evaluation Centre, Vancouver
Study Director: Shelly McNeil, MD Centre for Vaccinology, Halifax
Study Director: Scott Halperin, MD Centre for Vaccinology, Halifax
Study Director: Joanne Langley, MD Centre for Vaccinology, Halifax
Study Director: Marc Dionne, MD Centre de Recherche du CHUL (CHUQ), Quebec
Study Director: Bernard Duval, MD Centre de Recherche du CHUL (CHUQ), Quebec
University of British Columbia
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP