Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501137
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2007-07-11
Brief Title:
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Sponsor:
Simon Dobson
Organization:
University of British Columbia
Study Overview
Official Title:
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCGov-01
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 17 - 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None