System Info - 101582 SHONE, DEANNA 06-Aug-2009 16:24:30 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: 21-MAY-2009 12:00 AM Initiated by FDA? Yes
Author: COLLEEN SWEENEY
RE: E-mail for clinical study coments
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
|Date:||May 21, 2009|
|From:||CDR C. Sweeney, MS, Regulatory Coordinator|
|Subject:||CBER Clinical Comments on STN 125324|
Based on review of the clinical study portions of your BLA (STN 125324), Dr. Tina Khoie has the following comments:
- In your May 14th response to clinical comments (Module 1.11.3, response 3.1.c), you indicate that you can provide a list of Adverse Events (AEs) recorded as “started on the day of vaccination”. Please submit this information for all studies in BLA 125324.
- Regarding CSR-69238-report-body for study 004, please provide the serotype-specific GMRs and corresponding 95% CI for the pre-toddler dose pneumococcal IgG GMC data in Table 9-11 (pg 92). For presentation of the data for the additional 6 serotypes, please compare GMCs in the 13vPnC group to the 7vPnC reference; this reference is the lowest GMC among the 7 common serotypes in the 7vPnC group.
- In the CSR-report-body for studies 004 and 006, we note that solicited systemic events tables do not include the total % of subjects who used antipyretics to treat and/or to prevent symptoms related to vaccination. If not already submitted, please provide these data for all studies in BLA 125324.
- We note that for study 006, the action and outcome for the toddler dose and 6-month follow-up Serious Adverse Event (SAE) tables (Table 15.71 in CSR-74361 and Table 6.2 in the CSR-74361 follow-up addendum) were not provided. Please provide these data for study 006. Please also submit these data if they were not included in the SAE safety tables for any other CSRs submitted in BLA 125324.
- Please submit a version of all safety tables for study 3005 showing data for the three 13vPnC lot groups combined. Please also include a copy of these tables in Microsoft Word documents.
- For study 3005, please submit a list of protocol violations that did not result in exclusion from any of the safety or immunogenicity analysis populations.
- Please specify which nonstudy medications listed in Tables 15.6 and 15.7 in CSR-74251-report-body (study 3005) were not permitted by the protocol (i.e. not administered within the protocol specified timeframes for non-study vaccinations).