Record of Telephone Conversation, May 19, 2014 - TRUMENBA

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: 19-May-2014 12:48 AM Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s):
1. Information Request
2. Other - Two IR's for studies B1971004, -1005 and -1042

Author: MICHAEL SMITH

Telecon Summary:
Two IR's for studies B1971004, -1005 and -1042

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: Monday, May 19, 2014 2:48 PM
To: Devlin, Carmel (Carmel.Devlin@pfizer.com)
Cc: Burns, Drusilla L.; Garnett, Theodore; Naik, Ramachandra
Subject: STN 125549: IR regarding studies B1971004, B1971005 and B1971042

Carmel,

CBER has the below information requests regarding studies B1971004, B1971005 and B1971042, please confirm receipt of these comments.
1.We note that study reports for studies B1971004 and B1971005 were generated prior to changing the method of hSBA titer calculation (i.e. hSBA response rates based on --------------------------(b)(4)-----------------------------).  Please clarify how hSBA titers were calculated for both of the studies. 
1.Also, for study B1971042, please confirm that the hSBA titers were calculated by the agreed upon method.

Regards,

Mike

Mike Smith, Ph.D.
LCDR, 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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