System Info - 112371 SMITH, MICHAEL J 30-Nov-2009 15:22:09 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: 19-AUG-2009 11:08 AM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
Email: IR for additional information related to mumps and varicella data for studies 3005 and 004.
FDA Participants: Julienne Vaillancourt, Michael Smith and Colleen Sweeney
Non-FDA Participants: Devlin Carmel, Love Jack
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Vaillancourt, Julienne
Sent: Wednesday, August 19, 2009 11:08 AM
To: 'Carmel Devlin'; 'Jack Love'
Cc: Smith, Michael (CBER); Sweeney, Colleen
Subject: Request for Validation Data on Mumps & Original Varicella Assays
Dear Carmel and Jack,
As we previously discussed with you on July 16, 2009, the response rates to mumps and varicella were noticeably low across both study groups in study 6096A1-004, i.e., (for varicella, using the Captia™ VZV IgG ELISA, the proportions of responders at 1.09 I.V. were 26.7% and 21.9% for the 13vPnC and 7vPnC groups, respectively; and for mumps, using the Captia™ Mumps IgG ELISA the proportions of responders at 1.10 I.V. were 76.5% and 72.% for the 13vPnC and 7vPnC groups, respectively). You explained to us that an inappropriate varicella assay had been used for this purpose in this study. At that time you mentioned the availability of new varicella response data from study 6096A1-3005 generated using an appropriate assay for measuring response to varicella vaccine. We afterward requested submission of those data to the BLA. We acknowledge your August 6, 2009, BLA amendment, which contains varicella data from study 6096A1-3005 and validation information for the assay used in that study. We acknowledge that the response to varicella was much higher across both arms in study 3005. However, we would still like to learn more about why the responses to mumps and varicella were so low in study 004, particularly with regard to the assays used. The document, which summaries the MMV ELISA, in section 188.8.131.52 of your BLA, does not provide adequate information in this regard. Please provide information demonstrating that use of the Captia™ ELISA assays for mumps and varicella acted as predicted when used by your laboratory on sera from study 3005. In addition, please provide any other information that may be helpful to us in understanding the mumps and varicella results from study 004.
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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