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Vaccines, Blood & Biologics

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Vaccines

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)”