申请企业

Seqirus Inc.

药品名称

AUDENZ, Influenza A (H5N1) Monovalent Vaccine, Adjuvanted

状态

未解决

承诺描述

To establish a pregnancy registry in the U.S. that is able to prospectively collect data on an actively recruited cohort to study the safety of Audenz Vaccine during pregnancy. A draft protocol for this pregnancy registry will be prepared under the assumption that the vaccine would be distributed to the general population in the U.S. in an officially-declared H5N1 influenza virus pandemic. Once the circumstances of vaccine usage in an officially-declared H5N1 influenza virus pandemic are determined by the U.S. Government, Seqirus will work with the FDA, in coordination with BARDA (Biomedical Advanced Research and Development Authority) and CDC (Center for Disease Control), to finalize the protocol and initiate the registry.

承诺状态描述

报告接收日期

2021/3/19 0:00:00

批准日期

2020/1/31 0:00:00

截止日期

CDER/CBER

CB

子类型标记