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

N/ANot Yet RecruitingNCT07268612

Emergent BioSolutions250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Anthrax

Interventions

CYFENDUSBIOLOGICAL

Intramuscular administration of two doses of Anthrax Vaccine Adsorbed, Adjuvanted

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Individuals who did not receive CYFENDUS for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.

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.

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

Data from ClinicalTrials.gov

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