Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122681
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2005-07-20
Brief Title:
Human Papilloma Virus HPV Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline GSK Biologicals HPV-1618
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Double-blind Randomized Controlled Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals HPV-1618 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia Administered Intramuscularly According to a 0 1 6 Month Schedule in Healthy Females 15-25 Years of Age
Status:
COMPLETED
Status Verified Date:
2017-08
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 study will evaluate the efficacy of GSK Biologicals HPV 1618 VLPAS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety over 48 months in young adolescents and women of 1525 years of age at study start Approximately 18000 study subjects will either receive the HPV vaccine or a control vaccine hepatitis A vaccine administered intramuscularly according to a 0-1-6 month schedule
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:
NOTE Some 178 centers participate in this study Given that the recruitment is completed the researchers have listed one center per country in this website If required further details of centers available on request
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