Record of Telephone Conversation, March 27, 2012 PM - 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: 27-Mar-2012 03:20 PM Initiated by FDA? Yes

Telephone Number: jody.a.gould@gsk.com

Communication Categorie(s):
1. Advice

Author: KIRK PRUTZMAN

Telecon Summary:
Clarification of CBER's advice regarding Item 13 in the LRP comments (Sent to GSK on 3/20/2012)

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN

Non-FDA Participants: JODY GOULD, NORRIS PYLE

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

From: Prutzman, Kirk C
Sent: Tuesday, March 27, 2012 3:22 PM
To: 'Jody Gould'; 'Norris Pyle'
Cc: Temenak, Joseph ; Staten, David
Subject: STN 125363 - LRP Comments Item 13 Response

Dear Jody,

We have received feedback from the reviewers regarding Item 13 of the Lot Release Protocol Comments (sent to GSK on 3/20/2012).

We suggest that the ----(b)(4)----- Testing of TT be removed at the Purified TT stage and be added to the Purified and -----(b)(4)----- TT and the Purified and -------(b)(4)------- TT. We feel that this is important based on the following:

1. This is an important safety test that confirms no reversion to active tetanus toxin.
2. Purified TT can be stored for ------(b)(4)------ (still working on defining the expiry).
3. It has been shown that –b(4)-- purification / -b(4)--------of TT has the potential for reversion to active tetanus toxin.

Regards,

Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville , MD 20857
Phone: (301) 796-2640