Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492544
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2007-06-26
Brief Title:
Immunogenicity and Safety of GSK Biologicals HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals HPV Vaccine 580299 When Administered as a 3-dose Schedule in Healthy Japanese Pre-adolescent and Adolescent Female Subjects
Status:
COMPLETED
Status Verified Date:
2018-08
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:
None
Brief Summary:
Human papillomavirus HPV infection has been established as a necessary cause of cervical cancer GSK Biologicals has developed an HPV vaccine 580299 which targets the 2 most common oncogenic HPV types HPV-16 and HPV-18 found in approximately 70 of all cervical cancers In previous trials the vaccine has been found to be efficacious in the prevention of incident and persistent HPV-1618 infections and associated cytological abnormalities HPV vaccination should ideally be performed before onset of sexual activity Previous studies showed that GSK Biologicals HPV vaccine 580299 is safe and immunogenic when administered to European Asian Latin American and Australian pre-adolescents and adolescents Here we aim to assess the immunogenicity and safety of the GSK Biologicals HPV vaccine 580299 in healthy Japanese pre-adolescent and adolescent female subjects aged 10-15 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
None
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