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Record of Telephone Conversation - October 6, 2009 - Prevnar 13
System Info - 111933 SMITH, MICHAEL J 23-Nov-2009 18:05:12 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: 06-OCT-2009 11:04 AM Initiated by FDA? Yes
Author: COLLEEN SWEENEY
Email: IR for immunogenicity data for study 3005 and 008.
FDA Participants: Julienne Vaillancourt, Tina Khoie and Michael Smith
Non-FDA Participants: Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Sweeney, Colleen
Sent: Tuesday, October 06, 2009 11:04 AM
Cc: Vaillancourt, Julienne; Khoie, Tina; Smith, Michael (CBER)
Subject: RE: Request for data submission to STN: 125324 previously submitted to IND 11673
In regard to the telephone message I had left earlier this morning I just wanted to follow up with an e-mail:
On July 15, 2009, amendment 229 was submitted to IND –(b)(4)-. This amendment contained the following data:
1) New immunogenicity data from study 3005, including pneumococcal NI data (comparison of data from 3 pooled 13vPnC lots to the 1 7vPnC lot), post infant and toddler doses.
2) Toddler dose immunogenicity data (OPA and IgG) from study 008 to support the transition schedule from 7vPnC to 13vPnC.
Please submit this data to STN: 125324.
End of email