Record of Telephone Conversation, August 10, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 10-Aug-2012 10:00 AM Initiated by FDA? Yes
Telephone Number: 617-871-8325
1. Information Request
Author: TIMOTHY NELLE
Request for non-inferiority study statement for 6m - 4yos
FDA Participants: TIMOTHY NELLE
Non-FDA Participants: Matt Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Novartis was informed that OVRR management has expressed great concerns about modifying V58P16 for the purposes of demonstrating of non-inferiority in children 6 months to less than 4 years old. As such, DVRPA requests a simple paragraph describing a separate clinical study to demonstrating non-inferiority. This paragraph only needs to identify the ages of the subjects, the sample sizes of the study groups, and the approximate dates for protocol submission, study start, and FSR.
DVRPA understands that this statement will only reflect a preliminary clinical plan that Novartis may choose modify during the review of this BLA.
DVRPA requested a response no later than early Monday morning. Novartis was also informed that if their management would like to discuss this situation with OVRR management, they should contact Dr. Theresa Finn.