Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496626
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2007-07-03
Brief Title:
An Immunogenicity and Safety Study of Gardasil in Chinese Subjects V501-030COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
An Immunogenicity and Safety Study of Quadrivalent HPV Types 6 11 16 18 Virus-Like Particle VLP Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 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:
This is a China registration study A randomized double-blind placebo-controlled immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male participants aged 9 to 15 years Approximately 600 participants will be randomized in a 11 ratio to receive either vaccine or aluminum-containing placebo Each participant received one injection at each visit at Day 1 Month 2 and Month 6 Vaccine or placebo was given as a 05-mL intramuscular injection Serum will be collected from all participants to evaluate immune response against anti-Human Papillomavirus HPV 6111618 with Luminex Assay At Month 2 Month 6 Month 7 subjects will be evaluated for any new medical condition or health concerns and Serious Adverse Experiences throughout the study The primary objective is to evaluate the vaccine-induced serum anti-HPV 6 11 16 and 18 antibody titers following 3-dose regimen of Gardasil compared with placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007_021 | None | None | None |