About this trial
The goal of this observational study is to evaluate the safety and clinical benefit of two doses of CYFENDUS vaccine when used with the concurrent recommended antibacterial regimen for post-exposure prophylaxis to prevent inhalational anthrax and/or anthrax meningitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals who received any dose of CYFENDUS vaccine (with or without concurrent recommended antibacterial regimen) for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.
Disqualifiers
Individuals who did not receive CYFENDUS for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.
Trial population
The study population will include adults for which CYFENDUS is indicated (18 to 65 years of age), but it may include pediatric, pregnant, and geriatric populations if they are vaccinated with CYFENDUS based on public health recommendations as part of outbreak management.
Trial design
Case-only
Retrospective
Treatments tested in this trial
CYFENDUS
Biological/VaccineIntramuscular administration of two doses of Anthrax Vaccine Adsorbed, Adjuvanted
Treatment groups
Trial outcomes
Primary outcomes
Number of individuals who developed inhalational anthrax and/or anthrax meningitis and received CYFENDUS for post exposure prophylaxis divided by the total number reported to have received CYFENDUS for post exposure prophylaxis.
Locations
Sponsors and contacts
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