Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359619
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2006-07-18
Brief Title:
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Long-term Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study
Status:
COMPLETED
Status Verified Date:
2019-12
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 Indeed certain oncogenic types of HPV can infect the cervix part of the uterus or womb This infection may go away by itself but if it does not go away this is called persistent infection it can lead in women over a long period of time to cancer of the cervix GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant control vaccine and is also evaluating novel HPV vaccines formulations This study will evaluate the long-term immunogenicity and safety of a novel GSK Biologicals vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in 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:
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-003766-14 | EUDRACT_NUMBER | GSK | None |
| 107919 | OTHER | None | None |
| 107921 | OTHER | None | None |
| 107918 | OTHER | None | None |