System Info - 120913 SMITH, MICHAEL J 23-Feb-2010 13:43:04 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: 10-DEC-2009 08:30 AM Initiated by FDA? Yes
Author: JULIENNE VAILLANCOURT
Clarification on identified discrepancies in the final protocol for the post marketing safety study 4002.
FDA Participants: Julienne Vaillancourt, Marthe Bryant and Bob Wise
Non-FDA Participants: Bill Gruber, Dan Scott, Jay Graepel, Kim Center, Alicia Gonzalez, Jack Love and Carmel Devlin
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Record of Teleconference
Date/Time: December 10, 2009 8:30 AM
File: BLA 125324
Product: Prevnar 13™
Sponsor: Wyeth Pharmaceuticals Inc.
Subject: Request for Clarifications on Study 4002 Protocol Version Submitted 12/2/2009
CBER Participant: Marthe Bryant, Bob Wise, Julienne Vaillancourt
December 2, 2009, Amendment to BLA (Module 1.11.3 and 220.127.116.11.4): response to Agency request for information, i.e. response to 11/24/2009 CBER communication and “final” protocol for study 6096A1-4002).
The purpose of this teleconference was to request clarification on identified discrepancies in the final protocol for the post marketing safety study 4002.
CBER noted the following discrepancies in the recently submitted protocol for study 4002:
- The number of expected subjects noted in the recent protocol (i.e., 162,305) seems larger than what CBER understood to be the number (i.e., 65,927).
- The protocol indicates that analyses will be conducted separately for each setting; whereas CBER thought that analyses also would be done for all settings combined.
- It is unclear whether any diagnoses that present a signal as safety data are accumulated across settings would be included in the analyses and how. CBER expected that determination of what constitutes a signal would be jointly decided by CBER and the sponsor.
The sponsor confirmed that the number of expected participants is 65,927 children who would receive all three doses of the infant series. The sponsor explained that this cohort is a subset of a larger cohort of children who would receive at least a single dose of Prevnar 13. The sponsor asked for clarification from CBER regarding the other two points. After a brief discussion the sponsor agreed to revise the protocol to address these three issues.
A revised “final” protocol for post marketing safety study 6096A1-4002 will be submitted.