Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120848
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2005-07-12
Brief Title:
Follow-up Study of GSK Biologicals Human Papilloma Virus HPV Vaccine to Prevent Cervical Infection in Young Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study of the Efficacy of Candidate HPV 1618 VLP Vaccine in the Prevention of HPV-16 andor HPV-18 Cervical Infection in Adolescent Young Adult Women in North America and Brazil Vaccinated in Primary Study 580299001
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 Papilloma virus HPV are viruses that cause a common infection of the skin and genitals in men and women Several types of HPV infection are transmitted by sexual activity and in women can infect the cervix part of the uterus or womb This infection often goes 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 If a woman is not infected by HPV it is very unlikely that she will get cervical cancer This is an observer blind follow up study of the study HPV-001 which evaluated the ability of the HPV vaccine to prevent HPV infection The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccineplacebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine Subjects will remain in the same study group as in the primary study No vaccine or placebo will be administered in this 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