Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 10:42 AM
Study NCT ID:
NCT00764634
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2008-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Blind, Safety and Immunogenicity Study of Recombinant Botulinum Vaccine A/B
Sponsor:
DynPort Vaccine Company LLC, A GDIT Company
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety, Dosing Schedule and Antibody Kinetics of Recombinant Botulinum Vaccine A/B, rBV A/B-40, in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2011-11
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 Phase 2 study is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B-40 vaccine or placebo in healthy adults, using two different three-dose dosing schedules.
Detailed Description:
The study includes 18 months (547 days) of follow-up after the first vaccination for all randomized volunteers who receive at least one vaccination. Analysis of cumulative data collected through Day 547 ± 14 days will be reported in the final clinical study report.
Study Oversight
Has Oversight DMC:
True
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?: