
Information Request Email, Clinical Issues, October 1, 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: 01-Oct-2014 04:46 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR regarding Clinical Issues

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 01, 2014 4:46 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Information Request 

Dr. Stoehr,

Please find attached a request for additional information regarding STN 125546 (Meningococcal Group B Vaccine). 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


CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
 OFFICE OF VACCINES RESEARCH AND REVIEW
 DIVISION OF VACCINES AND RELATED PRODUCTS APPLICATIONS

DATE: OCTOBER 1, 2014       PAGES: 3

TO: NOVARTIS VACCINES AND DIAGNOSTICS, INC
 ATTENTION: PATRICIA STOEHR, PH.D.
 Senior Group Manager Regulatory Affairs
 Novartis Vaccines & Diagnostics

350 Massachusetts Avenue
 Cambridge, MA 02139 
 USA

FAX: (617) 871-8060     TEL: (617) 871-4711

FROM: KIRK PRUTZMAN, PH.D.
 Regulatory Project Manager
 FAX: (301) 595-1244     TEL: (301) 796-2640

SUBJECT:   STN: BL 125546/0 – Request For Information 

MESSAGE:

Dear Dr. Stoehr:

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

Regarding Study V72_41
1. Please provide a table listing the studies submitted as part of this BLA that used OMV NZ manufactured at the (b)(4) site and the studies that used OMV NZ manufactured at the Rosia site. In addition, please clarify which OMV NZ (manufactured at (b)(4) or Rosia site) is contained in Bexsero that is currently being marketed in each of these locations: Canada, Australia, and Europe. 

 Regarding Study V72_29
2.As described in Section 9.8 of the V72_29 CSR (Changes in the Conduct of the Study or Planned Analyses), subjects traveling to Japanese Encephalitis or meningococcal endemic areas were unblinded between Visit 5 (Month 6) and Visit 6 (Month 12) in order to obtain the appropriate preventive vaccinations. We note that these subjects remained in the trial until study completion. Please clarify the following:
a. What proportions of subjects across groups in the safety population were unblinded?
b. What steps were taken to reduce bias in the assessment of long-term safety? 
3.We note that 40 subjects received an unauthorized Japanese Encephalitis vaccine at Sites 5 and 7. Please clarify if these 40 subjects were included among the major protocol violations for the safety and immunogenicity analyses?

Regarding Study V72P10 and V72P10E1
4. We note that subjects in V72P10 Extension Study, who were previously enrolled in the parent study, retained the same unique 6-digit number, while vaccine-naïve control subjects were assigned new 6-digit numbers with the 3rd digit assignment of “6”, indicating ‘naïve-control’ status. Please clarify if the laboratory personnel running the hSBA assays for the Extension Study were blinded to these identification codes.

 Regarding Study V102_03
5.Please provide solicited reactogenicity data analyzed by country and by age (10-17 years old and 18-25 years old). In these analyses, please handle missing data as directed in our IR comments sent on September 23, 2014.

Regarding CDC Studies V72_68TP and V72_70TP
6. We note that in the UCSB Meningitis B Vaccine Clinic document (dated 5/20/2014) submitted under Am 0.2, Section 5.3.5.4, the total number of students who received Dose 2 was 7212. However, in the ISS, Table 2.1.3-6 (Summary of SAEs within 30 days of the 2nd Vaccination), the total number of subjects vaccinated in Study V72_70TP (USCB) was 7713 based on information dated 5/20/2014, provided to Novartis by CDC on 5/27/2014. Please clarify.

Please provide your responses to this information request in an Amendment to STN 125546 by October 31, 2014. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference. If you have any questions about this communication, please contact Kirk Prutzman, Ramachandra Naik, or Ed Wolfgang at (301) 796-2640. 
