Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211991
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2005-09-13
Brief Title:
Evaluation of Consistency of StaphVAX Manufacturing Lots
Sponsor:
Nabi Biopharmaceuticals
Organization:
Nabi Biopharmaceuticals
Study Overview
Official Title:
A Phase 3 Multicenter Double-Blinded Randomized Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2012-05
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 answers a US Food and Drug Administration requirement for evaluation in people of the consistency of manufacturing of a vaccine Subjects are randomized to one of three lots of vaccine The antibodies in the blood measure the immunogenicity of each lot of vaccine and typical vaccine safety information is also collected
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