Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518336
Status:
COMPLETED
Last Update Posted:
2016-12-09
First Post:
2007-08-17
Brief Title:
Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine 580299 in Healthy Young Adult Women in Brazil
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine 580299 in Healthy Young Adult Women in Brazil
Status:
COMPLETED
Status Verified Date:
2016-10
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 This Phase IIb study is designed to evaluate the the long-term efficacy safety and immunogenicity of the 580299 HPV vaccine CervarixTM in a Brazilian cohort of women vaccinated in the phase IIb blinded primary study 580299001 NCT00689741 and having participated in follow-up study 580299007 NCT00120848 Only subjects who participated in the primary follow-up study will be enrolled in this long-term follow-up study Subjects were aged 15-25 years at the time of entry into the primary study
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:
In this extension study women who were vaccinated in the primary study and participated in the follow-up study will be followed with visits every 6 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 109625 | OTHER | GSK | None |
| 109624 | OTHER | None | None |