A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Simon Dobson, MD
Principal Investigator
University of British Columbia
Canada: Health Canada
H07-00928
NCT00501137
July 2007
February 2008
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