Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426361
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2007-01-23
Brief Title:
Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus HPV Vaccine With Other Vaccines in Healthy Female Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals HPV Vaccine 580299 Co-administered With Boostrix Polio dTpa-IPV in Healthy Female Subjects Aged 10-18 Years
Status:
COMPLETED
Status Verified Date:
2017-04
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 Vaccination of pre-teens and adolescents ideally before sexual debut and thus before exposure to oncogenic HPV is a rational strategy for prevention of cervical cancer and so HPV vaccination could complement the existing pre-adolescentadolescents platform Therefore this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio dTpa-IPV with GSK Biologicals 580299HPV-1618 L1 AS04 vaccine Cervarix TM as compared to the administration of either vaccine alone
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