CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 328 enrolled
Drug / intervention
BioThrax® +1 morebiological
Likely dose
BioThrax® 0.50mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01641991
NCT01641991Phase 4Completed
CompareCT.gov

A Randomized Trial for the Assessment of Immunogenicity and Safety of Four Different Dosing Regimens of BioThrax® for Post-Exposure Prophylaxis for Anthrax in Adults

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 17, 2012·Updated May 28, 2014

In Brief

A Phase 4 clinical trial evaluating BioThrax® for Bacillus Anthracis (Anthrax). Completed, enrolled 328 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacillus Anthracis (Anthrax)
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2012
Enrollment StartJul 1, 2012
Primary CompletionMar 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.0 years ago

Interventions

BioThrax®biological

BioThrax® is a sterile, milky white suspension made from cell free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, will be administered as a 0.50mL IM injection 6 month boost for all groups

BioThrax®biological

BioThrax® will be administered as: Arm A: 0.50mL SC injection on Days 0 and 14; Arm B: 0.50mL SC injection on Days 0 and 28; Arm C: 0.50mL SC injection on Days 0, 14 and 28; Arm D: 0.25 mL SC injection on Days 0, 14 and 28.