Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211913
Status:
COMPLETED
Last Update Posted:
2008-01-04
First Post:
2005-09-13
Brief Title:
StaphVAX in Cardiovascular Surgery 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 Undergoing Cardiovascular Surgery
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 encountered in infection associated with cardiovascular surgery StaphVAX is a bivalent S aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides CPS that have been implicated as a major factor in the invasiveness of S aureus Immunoprophylaxis by vaccinating against S aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S aureus infection This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery
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