Record of Telephone Conversation,June 20, 2014 - TRUMENBA

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

Product:
Meningococcal Group B Vaccine

Applicant:
Wyeth Pharmaceuticals Inc.

Telecon Date/Time: 20-Jun-2014 04:37 PM Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s):
1. Information Request
2. Other - Autoimmune IR #2 

Author: MICHAEL SMITH

Telecon Summary:
IR on 1) Completion status of studies B1971009, -1014, -1015 and -1016, 2) DMC review of autoimmune events and safety data for the same studies and 3) Request for information updates that were dscribed in recommendation #3 of the May 20, 2014, DMC min's

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: Friday, June 20, 2014 4:37 PM
To: Devlin, Carmel (Carmel.Devlin@pfizer.com)
Cc: Burns, Drusilla L.; Garnett, Theodore; Naik, Ramachandra
Subject: STN 125549.0: Autoimmune cases IR#2

Carmel,

CBER has the below additional questions regarding autoimmune cases, please submit your responses in an amendment to the BLA.
1.Please provide CBER with an update on the study completion status for studies B1971009, -1014, -1015 and -1016.   
1.To what extent has the Pfizer Data Monitoring Committee (DMC) completed the review of autoimmune events and safety data from studies B1971009, -1014, -1015 and -1016?
1.Please provide the information updates that were described in recommendation #3 of the DMC May 20, 2014, meeting summary.

Regards,

Mike

- Please confirm receipt of this IR

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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