A Phase 4 Retrospective Observational Study of CYFENDUS™ Anthrax Vaccine Among Individuals Who Received Post-Exposure Prophylaxis Vaccination During a Bacillus Anthracis Mass Exposure Event

Emergent BioSolutions0 个研究点目标入组 250 人开始时间: 2035年11月1日最近更新: 2025年12月8日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Emergent BioSolutions
入组人数: 250
主要终点: 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.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Retrospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•Individuals who did not receive CYFENDUS for anthrax post exposure prophylaxis during an identified mass B. anthracis exposure event in the United States.

结局指标

主要结局

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.

时间窗: At least 12 months after containment of the mass exposure event

次要结局

未报告次要终点

研究者

发起方

Emergent BioSolutions

申办方类型

Industry

责任方

Sponsor

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