System Info - 113578 SMITH, MICHAEL J 11-Dec-2009 12:42:11 SMITHM
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125324/0 Office: OVRR
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals Inc.
Telecon Date/Time: 11-DEC-2009 11:56 AM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
IR for narratives for AE's resulting in withdrawal and for serious related events post toddler dose and 6-month follow-up safety data from study 6096A1-3005.
FDA Participants: Julie Vaillancourt, Colleen Sweeney and Mike Smith
Non-FDA Participants: Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Vaillancourt, Julienne
Sent: Friday, December 11, 2009 11:56 AM
To: 'Devlin Carmel'; 'Love Jack'
Cc: Smith, Michael (CBER); Sweeney, Colleen
Subject: request for study 3005 post toddler dose narratives
Dear Jack and Carmel,
Dr. Tina Khoie has the following request:
Please submit narratives for the AE's resulting in withdrawal and for serious related events described in the December 2, 2009 amendment, which contained the post toddler dose and 6-month follow-up safety data from study 6096A1-3005.
Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US Public Health Service
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration
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End of telecon.