Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 2:09 AM
Study NCT ID:
NCT00485732
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2007-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly in Healthy Female Subjects Aged 15 - 25 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. 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 GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) 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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: