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Brief Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Official Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Study ID: NCT00501137
Brief 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.
Detailed Description: 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.
Minimum Age: 9 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Vaccine Evaluation Centre, Vancouver, British Columbia, Canada
Name: Simon Dobson, MD
Affiliation: University of British Columbia
Role: PRINCIPAL_INVESTIGATOR
Name: David Scheifele, MD
Affiliation: Vaccine Evaluation Centre, Vancouver
Role: STUDY_DIRECTOR
Name: Meena Dawar, MD
Affiliation: Vaccine Evaluation Centre, Vancouver
Role: STUDY_DIRECTOR
Name: Tobias Kollman, MD
Affiliation: Vaccine Evaluation Centre, Vancouver
Role: STUDY_DIRECTOR
Name: Shelly McNeil, MD
Affiliation: Centre for Vaccinology, Halifax
Role: STUDY_DIRECTOR
Name: Scott Halperin, MD
Affiliation: Centre for Vaccinology, Halifax
Role: STUDY_DIRECTOR
Name: Joanne Langley, MD
Affiliation: Centre for Vaccinology, Halifax
Role: STUDY_DIRECTOR
Name: Marc Dionne, MD
Affiliation: Centre de Recherche du CHUL (CHUQ), Quebec
Role: STUDY_DIRECTOR