Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196924
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2005-09-13
Brief Title:
Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-1618
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate the Safety and Immunogenicity of GSK Biologicals HPV-1618 Vaccine Administered Intramuscularly According to a 016 Month Schedule in Healthy Female Subjects 10 - 14 Years
Status:
COMPLETED
Status Verified Date:
2017-03
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 safety and immunogenicity of GSK Biologicals HPV-1618 vaccine over 12 months in pre-teen and adolescent women of 10-14 years of age at study start Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine hepatitis A vaccine administered intramuscularly according to a 0-1-6 month schedule
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