Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
3,8620
Trial Sponsor
Clinical Trial Start Date
March 11, 2019
0Primary Completion Date
August 6, 2020
0Study Completion Date
August 6, 2020
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Biological0
Intervention Name
BioThrax0
AV79090
Interventional Trial Phase
Phase 30
Participating Facility
Official Name
A Phase 3, Randomized, Double-blind, Parallel-group Trial to Evaluate the Lot Consistency, Immunogenicity, and Safety of AV7909 for Postexposure Prophylaxis of Anthrax in Healthy Adults0
Last Updated
December 21, 2021
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Participant0
Care Provider0
Investigator0
Outcomes Assessor0
Study summary
This study is designed to evaluate the lot consistency (using three consecutively manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune response in healthy adults and compare the response to that induced by the currently licensed vaccine, BioThrax®, (Anthrax Vaccine Adsorbed; AVA) for post-exposure of anthrax disease.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.