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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, October 25, 2012 - 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

Telecon Date/Time: 25-Oct-2012 10:33 AM        Initiated by FDA? Yes

Telephone Number: michael.p.schwartz@gsk.com; robert.d.brobst@gsk.com

Communication Categorie(s):
1. Other -

Author: KIRK PRUTZMAN

Telecon Summary:
Communication of comments from the review of the Van Buynder et al. study

FDA Participants: KIRK PRUTZMAN, CARMEN COLLAZO, JEREMY WALLY

Non-FDA Participants: MICHAEL SCHWARTZ, ROBERT BROBST

Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:
 From:        Prutzman, Kirk C
Sent:                      Thursday, October 25, 2012 10:33 AM
To:                         Michael Schwartz; Robert Brobst
Cc:                         Collazo, Carmen; Wally, Jeremy
Subject:                 STN 125419 - Comments on the Van Buynder et al. Study

Attachments:          Discipline Review Van Buynder Study_final-clean-cert.pdf

Dear Drs. Schwartz and Brobst,

Please find attached CBER's comments from our review of the pivotal effectiveness study “A Test-negative Case-Control Study to Evaluate the Effectiveness of GSK Biologicals’ Adjuvanted Monovalent Inactivated H1N1 Influenza Vaccine (Arepanrix) in Young Children (6 months to < 10 years of age)” found in section 5.3.5.4 of your biologics license application (BLA) for Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (STN 125419).  We reference a teleconference meeting between CBER and GSK dated August 10, 2012, when we agreed to provide you with these comments. 


If you have any questions about this communication, please contact Kirk Prutzman, Carmen M. Collazo, or Jeremy Wally.
Regards,

Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville, MD  20857
Phone:  (301) 796-2640