System Info - 115828 SMITH, MICHAEL J 06-Jan-2010 16:03:49 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: 22-DEC-2009 12:00 AM Initiated by FDA? Yes
Author: COLLEEN SWEENEY
Email: IR for line listings of subjects who experienced serious adverse events (SAEs) within 30 days of the Toddler Dose and during the six month follow-up period for Study 3005.
FDA Participants: Colleen Sweeney, Tina Khoie, Lucia Lee and Julie Vaillancourt
Non-FDA Participants: Jack Love
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
|Date:||December 22, 2009|
|From:||CDR C. Sweeney, RN, MS, Regulatory Coordinator|
CBER requests the following information be submitted to BLA
A line listing(similar to Tables 15.164 and 15.165 on pages 400-401 in CSR69238) of subjects who experienced serious adverse events (SAEs)within 30 days of the Toddler Dose and during the six month follow-up period for Study 3005.
The line listing should include the following:
a. Site and subject number.
b. Reported MedDRA PT term(s).
c. Vaccine administered.
d. Vaccine dose administered.
e. Vaccine dose number.
f. Days since last administered dose.
g. Duration, severity, and outcome of administrated dose.
We note that this information was not included in the submission of December 2, 2009, Amendment #57 to BLA 125324/0.
End of email