
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