At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 305 enrolled
Drug / intervention
BioThrax +2 morebiological
Likely dose
Not stated in 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.
Randomized, Active-Comparison, Double-Blind, Phase 2 Study to Assess the Safety and Immunogenicity of Anthrax Vaccine Adsorbed (BioThrax®) Without and With CPG 7909 Adjuvant (AV7909 Anthrax Vaccine), Using a Post-Exposure Prophylaxis Dosing Regimen in Adults 66 Years of Age or Older in Stable Health in Comparison to Adults 18-50 Years of Age in Stable Health
Biomedical Advanced Research and Development Authority·interventional·Posted May 8, 2018·Updated Jul 21, 2020
In Brief
A Phase 2 clinical trial evaluating BioThrax, AV7909, and 1 other intervention for Anthrax. Completed, enrolled 305 participants across 4 sites.
Detailed Summary
This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.
Study Details
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartMay 2018
Primary CompletionJan 2019
Study CompletionDec 2019
TodayJul 2026
First PostedMay 8, 2018
Enrollment StartMay 9, 2018
Primary CompletionJan 14, 2019
Study CompletionDec 9, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.2 years ago
Interventions
BioThraxbiological
Other Names: Anthrax Vaccine Adsorbed (AVA)
AV7909biological
Anthrax Vaccine Absorbed plus CPG 7909 Adjuvant
Sodium chloride injection USP, 0.9% (placebo)drug
Other Names: Saline Solution