Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.

ConditionAnthrax
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEmergent BioSolutions

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • CYFENDUS

    Biological/Vaccine

    Intramuscular administration of two doses of Anthrax Vaccine Adsorbed, Adjuvanted

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
At least 12 months after containment of the mass exposure event

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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