Record of Telephone Conversation, January 18, 2011 - MenHibrix

Submission Type: BLA Submission ID: 125363/0 Office: OVRR

Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

Applicant:
GlaxoSmithKline Biologicals

Telecon Date/Time: 18-Jan-2011 01:45 PM Initiated by FDA? Yes

Telephone Number: --b(4)------------

Communication Categorie(s):
1. Meeting Scheduling Confirmation

Author: KIRK PRUTZMAN

Telecon Summary:
Notification of VRBPAC Meeting to be held on April 6-7 2011

FDA Participants: KIRK PRUTZMAN, JOE TEMENAK

Non-FDA Participants: JODY ANN GOULD

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Dear Dr. Gould,

A meeting was held late last week to discuss MenHibrix. From that meeting a decision was made to take MenHibrix to VRBPAC on April 6 and 7th. The agenda topic being discussed is:

• To discuss the use of immunologic markers for demonstration of effectiveness of meningococcal serogroups A, C, Y and W-135 conjugate vaccines administered to children less than 2 years of age.

Mr. Don Jehn is the Designated Federal Officer for VRBPAC and will be contacting you with VRBPAC/Agenda updates. He can be reached by calling:

POC: Don Jehn
Title: Designated Federal Officer for VRBPAC
Phone: 301-827-1293
Office: Division of Scientific Advisors and Consultants