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Record of Telephone Conversation - June 5, 2009 - Prevnar 13
System Info - 101584 SHONE, DEANNA 06-Aug-2009 16:32:35 SHONEDE
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: 05-JUN-2009 12:00 AM Initiated by FDA? Yes
Author: COLLEEN SWEENEY
RE: E-mail regarding request for Incidence rates for case counts of IPD serotypes
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
|Date:||June 5, 2009|
|Subject:||Serotype IPD data|
The following item pertains to the May 28, 2009, submission that contained serotype specific IPD data provided by the Center for Disease Control (CDC).
We note that you have provided case counts of IPD by serotype, year, and age group. We also note that you have denominator data for each age group and each year in the table which provides overall rates of IPD by year and age group. Incidence rates should therefore be easily calculated with these data. Please submit incidence rates by serotype, year, and age group.