Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT00822757
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2009-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2015-10
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 being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007_531 | None | None | View |