Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316693
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2006-04-19
Brief Title:
Human Papillomavirus HPV Vaccine Cervarix TM Efficacy Immunogenicity Safety Trial in Adult Japanese Women With GSK Biologicals HPV-1618 Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Study to Assess the Efficacy Immunogenicity and Safety of GSK Biologicals HPV-1618 L1 VLP AS04 Cervarix TM Vaccine Administered Intramuscularly According to a 0 1 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years
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:
Infection with human papillomavirus HPV has been clearly established as the central cause of cervical cancer Indeed certain oncogenic types of HPV can infect the cervix part of the uterus or womb This infection may go away by itself but if it does not go away this is called persistent infection it can lead in women over a long period of time to cancer of the cervix This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months the immunogenicity and safety of GSK Biologicals HPV-1618 vaccine Cervarix TM over 24 months in Japanese adult women aged 20 - 25 years of age at study start Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine Hepatitis A vaccine administered intramuscularly according to a 0-1-6 month schedule
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol Sections impacted are Official Title of the study and Intervention name
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