System Info - 110093 SMITH, MICHAEL J 06-Nov-2009 12:53:10 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: 15-OCT-2009 02:13 PM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
Email: Comments on phase 4 safety study, protocol # 6096A1-4002.
FDA Participants: Julienne Vaillancourt, Michael Smith, Colleen Sweeney, Marthe Bryant and Robert Wise
Non-FDA Participants: Carmel Devlin and Jack Love
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Vaillancourt, Julienne
Sent: Thursday, October 15, 2009 2:13 PM
To: 'Devlin Carmel'; Love Jack
Cc: Smith, Michael (CBER); Sweeney, Colleen; Bryant, Marthe; Wise, Robert
Subject: Comments on 10/1/2009 response to CBER 9/11/2009 ph4 safety study requests
The following comments are based on Dr. Marthe Bryant’s review of the October 1, 2009, amendment to your BLA, which contains a response to our September 11, 2009, comments concerning your proposed phase 4 safety study, protocol # 6096A1-4002, titled "Post-licensure Observational Safety Study of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Administered in Routine Use to Infants and Children":
- We acknowledge your agreement to provide reports with tabulated data according to the timelines noted in item 1.1 (pages 4-5) and your agreement to communicate any anticipated delay in submission of such reports immediately to CBER in the event of unforeseen extenuating circumstances. We would expect delays to be rare. If they do become frequent, we may wish to discuss the underlying reasons with you.
- With regard to the first bullet in item 1.1.c. (page 5), please confirm that the proposed draft interim and final reports will provide the frequency of each event in the experimental and comparison windows and frequency ratios.
- We acknowledge your concern that many events could appear significant at random as a result of multiple comparisons of data, if individual ICD9 codes are tabulated, per item 1.1.d.(3) (page 5). For the “every six month” reports, we agree with your proposal to primarily evaluate grouped diagnoses and “explode” these groups into individual ICD9 codes in the event that an unexpected “signal” is suggested. However, for the interim and final reports, we request tabulations of individual ICD9 codes, as originally requested. Please respond.
- With regard to item 2.1:
- We acknowledge your agreement to provide a primary analysis that will pool all identified high risk patients for which complete data may not be available.
- We also acknowledge your explanation that it may not be necessary to divide the primary analysis into two mutually exclusive subsets on the bases of diagnoses and pharmacy data, because the structure of NCKP database.
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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