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Record of Telephone Conversation, August 15, 2012, cont - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 15-Aug-2012 01:34 PM Initiated by FDA? Yes
1. Information Request
Author: TIMOTHY NELLE
Proposed timelines for pediatric studies
FDA Participants: Timothy Nelle
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
CBER requested Novartis’ anticipated dates for final protocol submission, study initiation, study completion, and final study report submission for the three proposed pediatric clinical studies (V58_31, V58P16, and V58_35).
Novartis proposed the following dates for the V58_31 study.
· Submit finalized protocol by December 2012
· Initiate study by May 2013
· Study Completion Date by May 2014
· Final CSR by September 2014.
Novartis proposed the following dates for the V58P16 study.
· Finalized protocol by October 2014
· Initiate study by May 2015
· Study Completion Date by May 2016
· Final CSR by September 2016
Novartis proposed the following dates for the V58_35 study.
· Finalized protocol by December 2016
· Initiate study by May 2017
· Study Completion Date by May 2018
· Final CSR by September 2018