CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
BioThraxbiological
Likely dose
BioThrax 0.5 mLfrom 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/NCT01491607
NCT01491607Phase 3Completed
CompareCT.gov

Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults

Emergent BioSolutions·interventional·Posted Dec 14, 2011·Updated Apr 9, 2024

In Brief

A Phase 3 clinical trial evaluating BioThrax for Anthrax. Completed, enrolled 200 participants across 4 sites.

Detailed Summary

The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax. This study will be conducted in the United States (U.S.), in 200 healthy male and female volunteer subjects ages 18 to 65 years. The duration of study participation for each individual subject will be approximately 128 days (4.25 months), including a screening period of approximately 28 days followed by 100 days on study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnthrax
CountriesUnited States
CollaboratorsDepartment of Health and Human Services

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2011
Enrollment StartNov 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.5 years ago

Interventions

BioThraxbiological

BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.