Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211926
Status:
COMPLETED
Last Update Posted:
2008-01-04
First Post:
2005-09-13
Brief Title:
StaphVAX Immunogenicity in Orthopedic Implant Patients
Sponsor:
Nabi Biopharmaceuticals
Organization:
Nabi Biopharmaceuticals
Study Overview
Official Title:
A Multicenter Randomized Placebo-Controlled Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adult Patients Receiving an Orthopaedic Prosthetic Implant
Status:
COMPLETED
Status Verified Date:
2007-12
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:
S aureus is the most common pathogen involved in prosthetic joint infection StaphVAX is a vaccine to prevent these infections which conjugates the purified capsular polysaccharides of S aureus to a carrier protein It is currently being evaluated for future licensing This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty
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