Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337818
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-06-15
Brief Title:
Human Papillomavirus HPV Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Long-term Open Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals HPV-1618 L1AS04 Vaccine in Healthy Female Subjects Vaccinated Either Pre- or Post-menarche in the Primary Study
Status:
COMPLETED
Status Verified Date:
2017-05
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:
The study will be extended for subjects who received all three doses of vaccine in Finland Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-1618 vaccine 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 GlaxoSmithKline 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
Detailed Description:
Approximately 750 study subjects received different lots of the HPV 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
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 |
|---|---|---|---|
| 107481 | OTHER | GSK | None |
| 107477 | OTHER | None | None |
| 107479 | OTHER | None | None |