
Information Request Email, Vaccine Lot Identifiers, October 10, 2014 - BEXSERO


 

 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR 

Product:
 Meningococcal Group B Vaccine 

Applicant:
 Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 10-Oct-2014 05:44 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
 IR regarding vaccine lot identifiers used in clinical studies

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C 
 Sent: Friday, October 10, 2014 5:44 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Information Request

Dr. Stoehr,

We have the following requests for additional information regarding STN 125546 (Meningococcal Group B Vaccine). 

We note that in Study V72P13, that the following vaccine lots were evaluated by country as follows: 
•Italy: X38D27N1A; X38D28N1; X38D29N1
•Austria: X38D27N1B; X38D28N1A; X38D29N1A
•Germany: X38D27N1B; X38D28N1A; X38D29N1A
•Finland: X38D27N1D; X38D28N1C; X38D29N1C and X38D27N1C; X38D28N1B; X38D29N1B
•Czech Republic: X38D27N1E; X38D28N1D; X38D29N1D 

Please clarify what the last character in the lot # designations listed above signifies (i.e. “A, B, C, D, or E”). 

Please confirm that the 3 lots evaluated in the five countries are the same across each country. 

Please provide your responses to this information request in an Amendment to STN 125546 by October 31, 2014. If you have any questions about this communication, please contact Kirk Prutzman, Ramachandra Naik, or Ed Wolfgang at (301) 796-2640.

Regards,

Kirk Prutzman, PhD
 Primary Reviewer/Regulatory Project Manager 
 CBER/OVRR/DVRPA/CMC3 
 Food and Drug Administration
 10903 New Hampshire Avenue
 Building 71 and Room 3041
 Silver Spring, MD 20993-0002
 Phone: (301) 796-2640
 Fax: (301) 595-1244
