Record of Telephone Conversation, September 18, 2014 - TRUMENBA

(System Info - 286902 SMITH MICHAEL 09/18/2014 14:38:30 SMITHM)

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125549/0     Office: OVRR

Product: Meningococcal Group B Vaccine
 Applicant: Wyeth Pharmaceuticals Inc.

Telecon Date/Time: 18-Sep-2014 02:27 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
 1. Information Request 
 2. Other - IR on responder rates for report VR-VTR-1-159

Author: MICHAEL SMITH

Telecon Summary: IR on responder rates for report VR-VTR-1-159

FDA Participants: Mike Smith, Drusilla Burns, Ted Garnett and Ram Naik

Non-FDA Participants: Carmel Devlin

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 
 See e-mail below:

From: Smith, Michael (CBER) 
 Sent: Thursday, September 18, 2014 2:27 PM
 To: Devlin, Carmel (Carmel.Devlin@pfizer.com)
 Cc: Burns, Drusilla L.; Garnett, Theodore; Naik, Ramachandra
 Subject: STN 125549: Information request regarding responder rates in report VR-VTR-10159

Carmel,

CBER has the attached Information Requests (IR’s) regarding the hSBA responder rates in report VR-VTR-10159.

Regards,

Mike

- Please confirm receipt of these IR’s.

 

Mike Smith, Ph.D.
 CDR, U.S. Public Health Service
 Regulatory Project Manager 
 U.S. Food and Drug Administration
 Center for Biologics Evaluation and Research
 Office of Vaccines Research and Review
 Division of Vaccines and Related Products Applications

Phone:     301-796-2640
 Fax:     301-595-1124
 E-mail:     michael.smith2@fda.hhs.gov

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See content of attached PDF below:

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

Date: September 18, 2014

Pages: 2

To: Carmel Devlin 
 Senior Director, Worldwide Regulatory Strategy
 Pfizer Inc. 
 Authorized Agent for: Wyeth Pharmaceuticals Inc.
 401 N. Middletown Road 
 Pearl River, NY 10965 
 Telephone: (485) 602-5537   Fax: (485) 602-4139

From: Division of Vaccines and Related Products Applications
 Office of Vaccines Research and Review
 Point of Contact: CDR Mike Smith, Ph.D.
 Regulatory Project Manager
 10903 New Hampshire Ave., White Oak Bldg. 71 
 Silver Spring, MD 2993-0002
 Telephone: (301) 796-2640   Fax: (301) 595-1124

STN#: 125549/0

Product: Meningococcal Group B Vaccine

Subject: CBER information request regarding the report VR-VTR-10159 entitled, “hSBA Responder Rates to MnB Strains Expressing Prevalent fHBP Variants Using Bivalent rLP2086 Immune Sera” that is located in eCTD section 4.2.1.1

1. We note that strains expressing 10 prevalent fHBP variants in the MenB SBA strain pool (Table 2, page 8) and additional meningococcal B strains (Table 3, page 9) were tested using individual young adult or adolescent sera.

a. For each strain and timepoint (prior to vaccination 1, post-dose 3), please provide the proportion of individuals with hSBA titer =1:8.

b. For strains PMB2948 [B24], PMB2707 [B44] and PMB2001 [A56] please provide the proportion of young adults with a 4-fold response defined as follows:
•A hSBA titer = 1:16, for subjects with a baseline (prior to vaccination 1) hSBA titer <1:4
•A hSBA titer = four times the baseline titer, for subjects with a baseline hSBA titer =1:4

In your reply to this information request, we recommend that you restate the 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, please contact CDR Mike Smith, Ph.D. at 301-796-2640.
