Document text
From: Smith, Michael (CBER)
Sent: Tuesday, June 29, 2021 3:47 PM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>
Subject: STN 125742.0: Clinical IR RE Study C4591001
Elisa,
The clinical team has the below IR regarding Study C4591001. The review team
would prefer a response by July 2, 2021.
Please provide the maximum date (latest date) of randomization for participants
included in the reactogenicity subset for Study C4591001. Our evaluation of the
datasets indicates that the maximum date of randomization (RANDDT) and
vaccination date 01 (VAX101DT) for participants included in the reactogenicity
subset is January 8, 2021. If based on your analyses, this date should be
different, please provide guidance to the datasets and the appropriate flags we
can use to confirm your results within the datasets.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applica tions
Tel: 301- 796- 2640
[email protected]
FDA-CBER-2021-5683-1024686
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS
ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a
person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action
based on the content of this communication is not authorized. If you have
received this document in error, please immediately notify the sen der
immediately by e- mail or phone.
FDA-CBER-2021-5683-1024687