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Record of Telephone Conversation, October 17, 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: 17-Oct-2012 09:34 AM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request


Telecon Summary:
IR comments: clinical (subgroup analyses) and clarification on filling of AS03 (---------------(b)(4)----------------)
FDA Participants: Jeremy Wally, Kirk Prutzman, Carmen Collazo
Non-FDA Participants: Robert Brobst; Michael Schwartz


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

From:                     Collazo, Carmen 
Sent:                      Wednesday, October 17, 2012 9:34 AM
To:                          Robert Brobst; Michael Schwartz
Cc:                          Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject:                IR request STN 125419
Importance:        High

Dear Drs. Schwartz and Brobst,
We have the following requests for additional information regarding STN 125419 (Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted):

1.   Please submit results of subgroup analyses of all primary immunogenicity and safety endpoints by age, race and gender in studies Q-Pan-001, Q-Pan-002 and the ISS analyses.

  1. In your response provide in the submission of September 10, 2012, (response to question 2), regarding the filling of AS03, you confirmed that (b)(4) filling methods,                        -------(b)(4)----------------------- are claimed.  Please clarify what you mean by “claimed” and state the method you plan to use for commercial filling.  Please clearly state whether you are seeking approval of (b)(4) methods.  If this is the case, please provide the following information:
    1. Provide a justification for using (b)(4) filling methods, ----------------------------(b)(4)-------.
    2. Explain the circumstances in which you will use either method and describe how you will track the adjuvant filled -------(b)(4)----------------------------.

Please submit your responses in an amendment to the BLA submission.
If you have any questions about this communication, please contact Kirk Prutzman, Carmen M. Collazo, or Jeremy Wally.

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