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Vaccines

Record of Telephone Conversation - Agriflu, November 24, 2009

(System Info - 112478 MCWATTERS BERNARD 12/01/2009 16:30:28 MCWATTERS)

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA    Submission ID: 125297/0    Office: OVRR

Product:Influenza Vaccine

Applicant: Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 24-Nov-2009 10:00 AM       

Initiated by FDA? Yes

Telephone Number: (617) 460-2376

Communication Categorie(s):

1. Advice

Author: BERNARD MCWATTERS

Telecon Summary: Advised Novartis that we would need a PMC to do a non-inferiority study with US licensed comparitor in adults 50 years and up.

FDA Participants: Melisse Baylor, Bernard McWatters

Non-FDA Participants: Joanne Totosy de Zepetnek, Hillel Cohen

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

After internal discussions with the clinical reviewers it was determined that a non-inferiority immunogenicity study would be needed comparing AGRIFLU to a US licensed trivalent vaccine. We also told Novartis that we needed this commitment before licensure and they would need to submit approximate dates with a month and a year when the protocol would be submitted, when the study would start and when the final study report would be submitted.  Novartis agreed to submit this as an amendment to the BLA.