
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