Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369824
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2006-08-28
Brief Title:
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Open Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals HPV Vaccine Co-administered Intramuscularly With Boostrix andor Menactra in Healthy Female Subjects Aged 11-18 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:
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 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix andor Menactra with GSK Biologicals HPV vaccine 580299 as compared to the administration of any of the vaccines 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