Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306241
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2006-03-16
Brief Title:
A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals HPV Vaccine in Healthy Women Aged 18-35 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Double-blind Randomized Controlled Study to Evaluate Immunogenicity and Safety of GSK Biologicals HPV-1618 L1 VLP AS04 Vaccine Administered Intramuscularly 0 1 6 Month Schedule in Healthy Females Aged 18 - 35 Years
Status:
COMPLETED
Status Verified Date:
2016-11
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 infection has clearly been recognized as the cause of cervical cancer Indeed the infection of the cervix by certain oncogenic types of HPV if not cleared can lead over time to cervical cancer in women This study will evaluate the immune response induced by the HPV-1618 L1 VLP AS04 vaccine and the safety of the vaccine
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 was primarily amended for the following reason
Mercks tetravalent HPV vaccine Gardasil has been licensed and is now becoming commercially available in an increasing number of countries Therefore the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study
Mercks tetravalent HPV vaccine Gardasil has been licensed and is now becoming commercially available in an increasing number of countries Therefore the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study
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