At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Parallel-arm, Double-blind, Randomized, Placebo-controlled, Dose-ranging Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of AV7909 in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating BioThrax, AV7909 Formulation 1, and 4 other interventions for Bacillus Anthracis (Anthrax) Infection. Completed, enrolled 105 participants across 3 sites.
Detailed Summary
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
Study Details
Timeline
Interventions
BioThrax
AV7909 Formulation 1
AV7909 Formulation 2
AV7909 Formulation 3
AV7909 Formulation 4
Saline control