Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344032
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2006-06-23
Brief Title:
Evaluation of the Immune and Safety Response of GlaxoSmithKline GSK Biologicals HPV Vaccine in Healthy Indian Women
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase IIIb Double-blind Randomized Controlled Study to Evaluate the Immunogenicity and Safety of GSK Biologicals HPV-1618 VLPAS04 Vaccine Administered Intramuscularly at 0 1 6 Months in Healthy Indian Female Subjects Aged 18-35 Yrs
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 L1AS04 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:
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