Vaccines, Blood & Biologics

Record of Telephone Conversation, February 19, 2013 - Q-Pan

Submission Type: BLA
Submission ID: 125419/0
Office: OVRR

Product:
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant:
ID Biomedical Corporation of Quebec (dba GlaxoSmithKline Biologicals)

Telecon Date/Time: 19-Feb-2013 02:17 PM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request
Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:

Information request on subjects 1666 and 5677 from study Q-Pan-H5N1-002

FDA Participants: Jeremy Wally, Kirk Prutzman, Carmen Collazo

Non-FDA Participants: Michael Schwartz; Jillian Horvath

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


From: Collazo, Carmen
Sent: Tuesday, February 19, 2013 2:17 PM
To: Michael Schwartz; Jillian Horvath
Cc: Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject: STN 125419 - please provide the following information
Importance: High

Dear Mike,

Reference is made to the response provided in Amendment 25, Module 1.11.2, submitted on February 1, 2013. Regarding subjects 1666 and 5677 from study Q-Pan-H5N1-002, please identify the page numbers in the Day 182 Annex report (or any other report in the BLA submission) were these diagnoses were reconsidered/reclassified. Also, please indicate where the Case Report Forms for these subjects were submitted. Please provide the requested information as soon as possible. Thank you!

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: carmen.collazo@fda.hhs.gov

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

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