Record of Telephone Conversation - December 22, 2009 - Prevnar 13

System Info - 115828  SMITH, MICHAEL J  06-Jan-2010 16:03:49  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:  22-DEC-2009 12:00 AM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  COLLEEN SWEENEY

Telecon Summary:
Email: IR for line listings of subjects who experienced serious adverse events (SAEs) within 30 days of the Toddler Dose and during the six month follow-up period for Study 3005.

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

Non-FDA Participants:    Jack Love

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Memorandum

Date:	December 22, 2009
To:	Jack D. Love, Ph.D.,  Vice President Global Regulatory Affairs, Wyeth Pharmaceuticals Inc.
From:	CDR C. Sweeney, RN, MS, Regulatory Coordinator
CC:	Tina Khoie, M.D., M.P.H., Clinical Reviewer Lucia Lee, M.D., Team Leader, VCTB, DVRPA CAPT Julienne Vaillancourt, R.Ph.,M.P.H.,Chair
Subject:	Information Request regarding Study 3005, “Randomized, Active-Controlled, Double-Blind Trial Evaluating Pilot and Manufacturing Scale 13vPnC in Healthy Pediatric Subjects in the United States.”

CBER requests the following information be submitted to BLA

125324/0:

A line listing(similar to Tables 15.164 and 15.165 on pages 400-401 in CSR69238) of subjects who experienced serious adverse events (SAEs)within 30 days of the Toddler Dose and during the six month follow-up period for Study 3005.

The line listing should include the following:

a. Site and subject number.

b. Reported MedDRA PT term(s).

c. Vaccine administered.

d. Vaccine dose administered.

e. Vaccine dose number.

f. Days since last administered dose.

g. Duration, severity, and outcome of administrated dose.

We note that this information was not included in the submission of December 2, 2009, Amendment #57 to BLA 125324/0.

End of email