Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071214
Status:
COMPLETED
Last Update Posted:
2006-07-11
First Post:
2003-10-15
Brief Title:
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
Sponsor:
Nabi Biopharmaceuticals
Organization:
Nabi Biopharmaceuticals
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Placebo-Controlled Double-Blinded Study to Evaluate Efficacy of StaphVAX a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus
Detailed Description:
Two part clinical trial designed to evaluate the efficacy of StaphVAX in adults on hemodialysis Part A will evaluate the prevention of bacteremic infections in End Stage Renal Disease ESRD patients during the interval between 3 and 35 weeks after a single dose of StaphVAX Part B of this study is designed to assess immunogenicity of a second booster dose of vaccine in patients completing Part A and the cumulative Part A B efficacy
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