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Vaccines, Blood & Biologics

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Vaccines

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


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

Applicant:
ID Biomedical Corporation of Quebec

Telecon Date/Time: 19-Aug-2013 01:19 PM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request

Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:
Request for information - clinical

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

 

Non-FDA Participants: Michael Schwartz

Telecon Body:
The following was communicated via e-mail correspondence.
______________________________________________
From:                     Collazo, Carmen 
Sent:                      Monday, August 19, 2013 1:19 PM
To:                          Michael Schwartz
Cc:                          Prutzman, Kirk C; Collazo, Carmen; Wally, Jeremy
Subject:                STN 125419 - Clinical IR (please respond ASAP)
Importance:        High

Dear Dr. Schwartz,

Please provide the following information:

  1. In the D364 WMEDIC dataset, subject 1279 has 4 unique records of angioedema requiring treatment.  Angioedema does not appear to be captured in the WUNSOL master or WOCEAN master for this subject.  Please comment and provide the subject’s CRF for review.
  1. In the D364 WMEDIC dataset, subject 6245 is listed as receiving a kidney transplant approximately 7 months post Dose 2 of vaccine.  The event does not appear to be captured in either the WUNSOL master or WOCEAN master.  Please comment and provide the subject’s CRF for review.
  1. In the D364 WMEDIC dataset, subject 7934 has a diagnosis of Type I DM made approximately 331 days post-vaccination.  The event does not appear to be captured in the WUNSOL master or WOCEAN master.  Please comment and provide the subject’s CRF for review.
  1. Please provide the CRF for subject 1620.

Please note that our review of your Biologics License Application (STN 125419) for Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted is ongoing and we may have additional requests for information.  Thank you!

Regards,

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