Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00092547
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2004-09-23
Brief Title:
A Study of Gardasil V501 in Preadolescents and Adolescents V501-018
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Safety and Immunogenicity Study of Quadrivalent HPV Types 6 11 16 18 L1 Virus-Like Particle VLP Vaccine in Preadolescents and Adolescents Base Study A Long Term Immunogenicity Safety and Effectiveness Study of GARDASIL Human Papillomavirus Types 6 11 16 18 Recombinant Vaccine Among Adolescents Who Received GARDASIL at 9-18 Years of Age Extension Study
Status:
COMPLETED
Status Verified Date:
2018-01
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:
This study is to evaluate the safety tolerability and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus HPV
Detailed Description:
The original base protocol V501-018NCT00092547 was extended in amendments V501-018-05 and -06 to provide 37 months of follow-up Additionally subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL V501 at Months 30 32 and 36
The study was extended again in amendment V501-018-10NCT00092547 titled A Long Term Immunogenicity Safety and Effectiveness Study of GARDASIL Human Papillomavirus Types 6 11 16 18 Recombinant Vaccine Among Adolescents Who Received GARDASIL at 9-18 Years of Age to allow a follow-up period to Month 126
The study was extended again in amendment V501-018-10NCT00092547 titled A Long Term Immunogenicity Safety and Effectiveness Study of GARDASIL Human Papillomavirus Types 6 11 16 18 Recombinant Vaccine Among Adolescents Who Received GARDASIL at 9-18 Years of Age to allow a follow-up period to Month 126
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 |
|---|---|---|---|
| 2004_084 | None | None | None |