Record of Telephone Conversation - October 1, 2009 - Prevnar 13

System Info - 120667  SMITH, MICHAEL J  19-Feb-2010 21:57:32  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  01-OCT-2009 12:00 AM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Other

Author:  COLLEEN SWEENEY

Telecon Summary:
RE: E-mail sent to Carmen Devlin regarding Mumps NI endpoint for study 6096A1-004

FDA Participants:   Colleen Sweeney, Tina Khoie, Lucia Lee and Julie Vaillancourt

Non-FDA Participants:    Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Memorandum

Date:	September 29, 2009
To:	Carmel Devlin, Associate Director Global Regulatory Affairs, Wyeth Pharmaceuticals Inc.
From:	CDR C. Sweeney, MS, Regulatory Coordinator
CC:	Tina Khoie, M.D., M.P.H., Clinical Reviewer Lucia Lee, M.D., Team Leader, VCTB, DVRPA Julienne Vaillancourt, R.Ph.,M.P.H.,Chair
Subject:	CBER Comments on STN 125324

Please respond to Dr. Jingyee Kou’s request below for additional information based on her review of data concerning analysis of the mumps non-inferiority (NI) endpoint in pivotal study 6096A1-004:

1. According to the final report for study 6096A1-004 (CSR-69238), provided in section 5.3.5.1.3, we note that the mumps NI endpoint was not met for the all-available toddler immunogenicity population. Table 9-21, in section 9.4.2.1 (page 117), of this report indicates that the evaluable toddler immunogenicity population for analysis of this endpoint included 221 subjects from the 13vPnC group and 210 subjects from the 7vPnC group. Whereas Table 15.54, in section 15 (page 274), of this report indicates that the all-available toddler immunogenicity population included 239 and 227 subjects, respectively. Please provide the identification number of each subject from the all-available population who was excluded from the valuable population for analysis of the mumps NI endpoint. In addition, please state the reason for subject exclusion.

Note: Although this was generated on September 29, 2009, it was not sent to the sponsor until October 1, 2009