Record of Telephone Conversation, August 22, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 22-Aug-2012 03:46 PM Initiated by FDA? Yes
1. Information Request
Author: TIMOTHY FRITZ
V58P14 study information.
FDA Participants: Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Wednesday, August 22, 2012 3:46 PM
To: 'Gollwitzer, Matthew'
Subject: CBER information request STN 125408
Dear Mr. Gollwitzer-
Our review of Novartis' Flucelvax Biologics License Application STN 125408 is ongoing. We have the following requests for additional information:
In your application, you refer to Study V58P14, an immunogenicity and safety study comparing Optaflu and Agrippal in adults and elderly with and without underlying medical conditions. You note that the study was prematurely terminated due to vaccine unavailability. Please provide the following information for Study V58P14:
1. Additional information for the reasons that Optaflu was unavailable for use in this study.
2. Line listings for serious adverse events.
3. Line listings for any adverse events consistent with an allergic reaction to either study vaccine.
Please submit the requested information as an amendment to STN 125408. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.
If you have any questions, please contact the Regulatory Project Manager, Drs Brenda Baldwin or Timothy Fritz, at 301-796-2640 or via e-mail.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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 notify the sender immediately by e-mail or phone.