Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule

NCT01641991 ↗

Phase 4 Completed 328 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupOpen-labelPrevention

Summary

A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a major biothreat.

Timeline

Start: 2012-07
Primary completion: 2013-03
Completion: 2013-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BioThrax	Vaccine	0.25 ml	Subcutaneous
Subject	BioThrax	Vaccine	0.5 ml	Subcutaneous

Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule

Summary

Timeline

Drugs

Indications