  


Information Request Email, Clinical Assessment Study Subject, December 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-Dec-2014 04:14 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: IR regarding the clinical assessment study subject

FDA Participants: None

Non-FDA Participants: None

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C 
 Sent: Monday, December 08, 2014 4:14 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Information Request

Dr. Stoehr,

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

In Study V72P10, we note that subject#11/0025, a 11 year old male, was diagnosed on December 16, 2008, with acute bacterial meningitis one month after his 3rd vaccination (11/19/2008). The subject was hospitalized and received prescription drug therapy and recovered. The investigator considered this SAE not related to vaccination, and the subject completed the protocol and received his 4th vaccination on April 07,2009. Please provide any additional information pertaining to this SAE, including final laboratory findings associated with this diagnosis. 

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
