Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00345878
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2006-06-28
Brief Title:
Study to Evaluate the Immune Response and Safety of GSK Biologicals HPV Vaccine in Healthy Women Aged 18-35 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase 3 Open Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals HPV-1618 Vaccine Administered Intramuscularly According to 3-dose Schedule 016 Months in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up
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 The infection of the cervix by certain oncogenic types of HPV if not cleared can lead to cervical cancer in women This study will evaluate the immunogenicity and safety of the HPV-1618 L1 VLP AS04 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 reasons
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
It was decided to offer GSK Biologicals HPV vaccine to all subjects in the control group at the end of the study The HPV vaccine will be offered to these subjects based on its local indication once the vaccine is marketed in Malaysia
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
It was decided to offer GSK Biologicals HPV vaccine to all subjects in the control group at the end of the study The HPV vaccine will be offered to these subjects based on its local indication once the vaccine is marketed in Malaysia
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