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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, August 15, 2012, cont - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
 
Product:
Influenza Vaccine (MDCK Cells)
 
Applicant:
Novartis Vaccines and Diagnostics, Inc.
 
Telecon Date/Time: 15-Aug-2012 01:34 PM        Initiated by FDA? Yes
 
Telephone Number:
 
Communication Categorie(s):
1. Information Request
 
Author: TIMOTHY NELLE
 
Telecon Summary:
Proposed timelines for pediatric studies
 
FDA Participants: Timothy Nelle
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
 
Telecon Body:
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