
Information Request Email, Clinical Data, October 8, 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: 08-Oct-2014 12:43 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
 IR regarding clinical data from study V102_03

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: Wednesday, October 08, 2014 12:43 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). 

For Study V102_03, please provide the following information by country (United States versus Poland)


1.demographic characteristics (similar to Table 11.2-1 in the V102_03 CSR)
2.subject disposition; protocol deviation; immunogenicity and safety data sets analyzed (similar to Tables 10.1-1; Figure 10.1-1; Table 10.2-1; Table 11.1-1; Table 11.1-2; Table 12.1-1 in V102_03 CSR)

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
