
Record of Email Communication, April 4, 2010 - 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: 04-Apr-2010 08:30 PM           Initiated by FDA? Yes

Telephone Number: Communication Category:

1. Information Request

 

Author: JASON HUMBERT

 

 

Telecon Summary:

Request for additional reagents, missing documents and specific questions about SOPs

 

FDA Participants: Jason Humbert

 

Non-FDA Participants: Norris Pyle; Jody Gould, PhD Telecon Body:

Attached is a request for reagents, documents and questions for the ongoing in-support testing for STN 125363/0.

 

----------------------------------------------( b)(4)------------------:

 

1.   ---------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------

 
-----------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------

 

2.   ----------------------------------(b)(4)----------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


 


1 Page Determined to be Not Releasable: (b)(4)


 

7.   Haemophilus influenzae type B: Determination of the ----------------(b)(4)--- of Hib in the combos HibMenCY by (b)(4)- PRR'P - TT (b)(4)- analysis SOP 9000010110
Please provide the temperature setting of the -----(b)(4)-------
Please provide the temperature setting of the -----(b)(4)-------
Please confirm that the correct lot number for -----(b)(4)-------is -----(b)(4)-------
Please confirm that the correct lot number for the internal control Hiberix (------------------(b)(4)---------------------------

 

 8.   (b)(4) Determination of Individual Polysaccharides in Final Container

HibMenCY by -----(b)(4)------ SOP 9000010603
Please provide a ----(b)(4)---- that illustrates an acceptable ---(b)(4)--- profile in as indicated in the SOP 5.8.1 Validity Criteria for the (b)(4)
