Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169494
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2005-09-12
Brief Title:
Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-1618
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Immunogenicity 3 Consecutive Lots of GSK Biologicals HPV-1618 Vaccine Administered Intramuscularly at 016 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process
Status:
COMPLETED
Status Verified Date:
2016-09
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 consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-1618 vaccine and the vaccine safety over 12 months in young adolescents and women of 10-25 years of age at study start Approximately 750 study subjects will receive different lots of the HPV 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