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Vaccines

Record of Telephone Conversation Requested Dates - Agriflu, September 21, 2009

System Info - 107217 MCWATTERS, BERNARD 07-Oct-2009 16:37:41 MCWATTERS

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application Submission ID: 125297/0 Office: OVRR

Product:
Influenza Vaccine

Applicant:
Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 21-SEP-2009 12:00 AM Initiated by FDA? No
Telephone Number:

Communication Categorie(s):
Other

Author: BERNARD MCWATTERS

Telecon Summary:
Requested dates for month and year dates of projected pediatric study dates.

FDA Participants:

Non-FDA Participants:

Trans-BLA Group: No


Related STNs: None

Related PMCs: None

Telecon Body:

Hi JP,
The commitment letter that was submitted in Amendment 0019 has been revised and will be re-submitted through the gateway today as Amendment 0020. A copy of the revised letter is attached for you to forward to the pediatric review committee members.

Below is the relevant excerpt from the letter with the updated completion dates:

"In response to a request received from Dr. Bernard (JP) McWatters by secure email on September 17, 2009 Novartis has updated the Post-Approval Commitments for AGRIFLU that were already submitted as Amendment 0019 (September 3, 2009) to provide both the month and year of the projected clinical trial completion dates.

Novartis is hereby committing to provide to the Agency the following items as Post-Approval Commitments for AGRIFLU:

  1. Novartis will provide a study protocol, conduct a clinical study, and subsequently provide results that evaluate use of AGRIFLU in children 3 years to 17 years of age.
  2. Novartis will provide a study protocol, conduct a clinical study, and subsequently provide results that evaluate use of AGRIFLU in children 6 months to 35 months of age.
  3. Novartis will establish a pregnancy registry for subjects that receive AGRIFLU.

We anticipate that the clinical study in the 3 to 17 years of age population will be started in September 2010 and finish approximately one year later (September 2011). After the safety and immunogenicity data from this study are available, a clinical study in the 6 to 35 months of age group will be initiated, potentially in September 2011 and finish approximately one year later (September 2012). Final results of these studies are planned to be submitted to the Agency in early 2013."

Can you please confirm that the attached letter addresses the committee's concerns and that the PeRC meeting will proceed on September 23, 2009 as scheduled?

Kind regards,
Joanne Totosy de Zepetnek, PhD
Vaccine Regulatory Affairs - North America
Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue
Cambridge, MA 02139-4182
Tel: (617) 871-7929
Fax: (617) 871-4711
Mobile: (617) 460-2376
Email: joanne.totosy@novartis.com