Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Emergent BioSolutions
Collaborators:
Department of Health and Human Services National Institute of Allergy and Infectious Diseases (NIAID)