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Record of Telephone Conversation - February 5, 2010 - Prevnar 13
(System Info - 119745 SHONE DEANNA 02/05/2010 16:36:03 SHONEDE)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 05-Feb-2010 10:00 AM Initiated by FDA? Yes
1. Information Request
Author: COLLEEN SWEENEY
CBER request for clarification regarding Serious Adverse Event Report submitted in Amendment 49 of STN 125324/0
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
Date: February 5, 2010
To: Carmel Devlin, Associate Director, Global Regulatory Affairs, Wyeth Pharmaceuticals Inc.
From: CDR C. Sweeney, MS, Regulatory Coordinator
CC: Tina Khoie, M.D., M.P.H., Clinical Reviewer
Lucia Lee, M.D., Team Leader, VCTB, DVRPA
Julienne Vaillancourt, R.Ph.,M.P.H.,Chair
Subject: CBER request for clarification regarding SeriousmAdverse Event Report submitted in Amendment 49 of STN 125324/0
We note the following discrepancy regarding the Serious Adverse Event Report for subject 000107 (Study 3005: Report -------(b)6)-----, Date of Report: Nov 2, 2009).
The report indicates that the subject was placed in the prone position to sleep at his Day Care Facility. However, the narrative for this same subject and event submitted in the CSR for study 3005, indicates that the subject was found supine in his crib. Please clarify if the subject was placed in the prone or supine position.