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Vaccines, Blood & Biologics

Record of Telephone Conversation, December 20, 2012 - Q-Pan

Submission Type: BLA

Submission ID: 125419/0

Office: OVRR

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

ID Biomedical Corporation of Quebec

Telecon Date/Time: 20-Dec-2012 08:18 AM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request


Telecon Summary:
IR on alternative ---(b)(4)------ used to storage the H5N1 ---(b)(4)--------

FDA Participants: Carmen Collazo-Custodio, Jeremy Wally, Kirk Prutzman

Non-FDA Participants: Michael Schwartz; Jillian Horvath; Robert Brobst

Telecon Body:
The following was communicated to GSK via e-mail correspondence:

From: Collazo, Carmen
Sent: Thursday, December 20, 2012 8:18 AM
To: Michael Schwartz; Jillian Horvath; Robert Brobst
Cc: Collazo, Carmen; Wally, Jeremy; Prutzman, Kirk C
Subject: STN 125419 Information Request
Importance: High

Dear Dr. Schwartz,

We have the following Information Request regarding the information provided in your submission dated December 13, 2012, to STN 125419 [Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted]:

1. The -----------(b)(4)---------- are used as alternative (b)(4) for storage of the H5N1 sterile ---(b)(4)-----. Please clarify if there were any modifications in the ports/connections for the ---(b)(4)--- used for the storage of H5N1 sterile ----(b)(4)------------- as compared to the (b)(4) tested by the supplier.

2. You have provided stability data using ----(b)(4)--- (in the original BLA submission), and media hold studies using ---(b)(4)-- (amendment 125419/0/22). These studies are supportive but not sufficient to demonstrate container closure integrity of the –(b)(4)------ used for storage of the sterile ---(b)(4)-------. Please provide the testing performed by IDB/GSK on the -(b)(4)-- used for the storage of the H5N1 sterile ----------(b)(4)--- to demonstrate the container closure integrity of the (b)(4).

3. The testing data provided for the extractable and leachable (E/L) studies on the----(b)(4)-- are less extensive compared to the ---(b)(4)----- (as performed by the supplier) and the data were provided as a summary. You indicated that additional E/L studies were conducted on these ---(b)(4)----. Please provide complete E/L data for the studies performed on the ------(b)(4)---- for storage of the H5N1 ---(b)(4)-----------------.


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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