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Vaccines, Blood & Biologics

Record of Telephone Conversation, May 21, 2012 - Q-Pan

Submission Type: BLA

Submission ID: 125419/0

Office: OVRR

Influenza A (H5N1) Virus Monovalent Vaccine

ID Biomedical Corporation of Quebec

Telecon Date/Time: 21-May-2012 01:14 PM Initiated by FDA? Yes

Telephone Number: 610-787-4884

Communication Categorie(s):
1. Advice


Telecon Summary:
Follow-up comment regarding your Pediatric Plan



Telecon Body:
The following was communicated to GSK via e-mail correspondence. GSK acknowledged receipt of the message.

From: Collazo, Carmen
Sent: Monday, May 21, 2012 1:14 PM
To: Kati Abraham
Cc: Prutzman, Kirk C; Wally, Jeremy
Subject: Follow-up comment regarding your Pediatric Plan STN BL 125419

Dear Kati,

Please see the following comment:

Reference is made to the conference call held on May 9, 2012, in which we had a general discussion about your Pediatric Plan for STN 125419. During this conference call you indicated that you are considering conducting additional pediatric studies to evaluate --------------(b)(4)---------------- based on recent results obtained in study FLU Q-PAN H5N1=AS03-021. As such, you plan to engage in discussions with GSK’s upper management and with BARDA to assess the possibility of conducting such studies. During this call we agreed to give you additional time for discussion and decision-making. CBER advised you to submit your new proposal as an amendment to the BLA by August. However, most recently, our internal Pediatric Review Committee (PeRC) meeting has been scheduled for the end of September. Given the timelines associated with preparation for the PeRC meeting, we are now requesting that you submit your Pediatric Plan by July 31, 2012. Your Pediatric Plan to support deferral requests must include a brief description of the pediatric studies that you plan to conduct or are conducting (i.e., the pediatric studies that will comprise the pediatric assessment), in addition to:

  • Final Protocol Submission Date
  • StudyCompletion Date
  • Final Report Submission Date

If the pediatric studies (ongoing or planned) are different from the ones described in Module 1.9.2 of the BLA submission, please submit your Pediatric Plan and clearly state that we are not to consider the information originally submitted in Module 1.9.2, dated February 22, 2012, for our review of your Pediatric Plan and PeRC meeting.

In addition, if possible, please provide the slides that you have prepared with a summary of FLU Q-PAN H5N1=AS03-021 study results.


Carmen M. Collazo-Custodio, Ph.D.
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Office location:
1451 Rockville Pike Rm. 2236
Rockville, MD 20852

Tel. 301-796-2640
Fax: 301-827-3532
E-mail address:

Mailing address:
Center for Biologics Evaluation and Research
Document Control Center HFM-481
1401 Rockville Pike
Rockville, MD 20852-1448

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