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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - April 20, 2009 - Hiberix

Submission Type: Original Application   Submission ID:  125347/0    Office: OVRR  

Product:

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Applicant:                                                                        

GlaxoSmithKline Biologicals          

Telecon Date/Time:  20-APR-2009 10:30 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  JASON HUMBERT

Telecon Summary:

Request for SOPs, reagents and the required samples for testing in-support for BLA.

FDA Participants: 
Jay Slater, M.D.
Jennifer  Bridgewater, MPH
Tina Roecklein
Scott Norris

Jason Humbert

Karen Campbell
Rajesh Gupta, Ph.D.
Alfred Del-Grosso, Ph.D.
James Kenney, Ph.D.
Manju Joshi, Ph.D.


Non-FDA Participants:   

Julie Bajart, Supervisor, QA Release
Carine Debaix, 1st Employee, QA Release and Submission US
Jody Ann Gould, Ph.D., Director, North American Regulatory Affairs - Vaccines
Elisa Harkins, Associate Director, North American Regulatory Affairs - Vaccines
Linda Kramer, Associate Director, North American Regulatory Affairs - Vaccines Establishment
Norris Pyle, Assistant Director, North American Regulatory Affairs - Vaccines CMC
Eric Sarlet, Senior Manager QA Release

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body: The sponsor was called by the Hiberix BLA review team to request the information listed below. Regarding the CBER request for the -----b(4)------------ by

--b(4)--- SOP, GSK clarified where the SOP could be found. For the other SOPs, CBER asked that they be submitted within 2-3 weeks. GSK stated that the SOPs will have to be translated to English but should be available to CBER within several days. CBER requested the following samples and a follow-up telecon for the week of April 26th will be scheduled. Call concluded and no further issues were discussed.

REQUESTS FOR SAMPLES AND REAGENTS FOR TESTING

  1. REAGENTS. Please provide information on concentrations and amounts required per test.

-b(4)- Reference preparation (for ---b(4)- ------ assay)

Final Container Internal control (for ----b(4)- ----assay)

Internal Control Hiberix (for --------b(4)------------------)

Standard of --------------b(4)- ------------------ assay)

 

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

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

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

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

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

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

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

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

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

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

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

  1. I.                SAMPLES

 

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

     

     

    QUESTIONS ON TESTING PROCEDURES

     

    III.       MISSING DOCUMENTS

    a.      Missing SOP -------b(4)- --------- content by -b(4)-

    Under 3.2.R Regional Information there are SOP’s for many of the assays.  One named “QC SOP PS content Hiberix” contains the document titled “Determination of the polysaccharide content in HIB Vaccine by -b(4)-” another one further down the list named “QC SOP    -b(4)- content Hiberix” contains exactly the same SOP.  Should the second one be the SOP for the -b(4)- content by -b(4)-?    

  1.             SOP or more detailed description for the Determination of -b(4)-  in Drug Substance
  2.              SOP or more detailed description for Determination of -b(4)-                                                ---b(4)-----content by ------b(4)- ---------------- in Drug Substance
  3.             SOP or more detailed description for -----b(4)- ----- Content in Drug Substance.

 

IV.    Questions on the SOP “Determination of the -------b(4)- --------- of Haemophilus influenzae type B by -b(4)-”

 

There appear to be a number of translation errors.  The SOP instructions are not clearly written.

 

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

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

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

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

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

          -----------------------

 

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

--b(4)---

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

 

--b(4)---

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

 

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

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

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

 

--b(4)--

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

 

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

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

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

 

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

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

 

1 Page determined to be not releasable: b(4)

 

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