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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Telecon Advice, January 8, 2010 - Menveo

 

Submission ID:                      Office: OVRR
BLA 125300   Menveo                                    

Title:            Meningococcal (Neisseria meningitidis) Tetravalent Oligosccharide Serogroups A, C, Y, W-135 Conjugate (diphtheria toxin CRM197; Corynebacterium diphtheriae) Vaccine

Sponsor:      Novartis Vaccines and Diagnostics Inc

Telecon Date/Time:   8-JAN-2010 12:08 PM            
Telephone Number:    (617) 871-4280

Author:                         CARA FIORE                         

Purpose:      ADVICE (AD)

FDA Participants:
CARA R FIORE

Sponsor Participants: 
CHRIS WEBSTER

Amendments:   None

References

  1. Fax 17NOV09 – see EDR
  2. Telecon 20NOV09 - see EDR
  3. Fax 01DEC09 - see EDR

Summary of Discussion: 
This telecon conveyed comments on the newest carton container submission (submitted 15DEC09, A018).  Novartis responded to all of CBER’s previous comments conveyed on 20NOV09, but the font on the MenCYW-135 drug product vial is not according to the CFR.  It appears that “MENVEO” is a wider font than “MenCYW-135” that is located on the vertical axis of the label vial.  After magnifying this on the screen, this is definitely the case.

Comments conveyed to sponsor:

  1. Please use the identical size font (or smaller) on the vial for the MenCYW-135 drug product as the typing in “MENVEO” on the vertical axis of the label.

 

MenACWY Conjugate Vaccine lot number : --------------- Reason for submission
    [  ] For release
Manufacturer name: Novartis Vaccines and Diagnostics Srl [  ] For surveillance
    [  ] For licensing action
Manufacturer address: Bellaria - Rosia, 53018 Sovicille        STN:
  --b(4)---(Italy) [  ] Corrected protocol
   
Trade name MENVEO
   
US License No. ---------------
   
Date of packaging ---------------
   
Type of packing container Box  (presentation)
   
No. of packing containers ---------------
   
No. of doses per final container ---------------
   
Volume of single human dose, after reconstitution 0.5 mL
of Men A lyophilized conjugate component powder  
with Men CWY liquid conjugate component  
   
Prescribed composition for human dose Men A oligosaccharide 10 mcg
  Men C oligosaccharide 5 mcg
  Men W oligosaccharide 5 mcg
  Men Y oligosaccharide 5 mcg
   
Expiry date ---------------
   
Date of start period of validity ---------------
   
Storage conditions of packed product 2 - 8°  C, protected from light. Do not freeze

All tests on this lot are reported and pass specifications as required.

_____________________________________               ______________________
 

Dr. Stefano Viti
Quality Assurance / Qualified Person

                                                                          Date

Summary
 
 
- Packaging Plan

---
 

 
- Meningococcal ACWY Conjugate Vaccine Lot ---------------

---
   

 
- Men A Lyophilized Conjugate Component Lot ---------------

---
   

 
- Men CWY Liquid Conjugate Component Lot ---------------

---

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

Tests on packing lot

 

Identity test for Meningococcal C conjugate vaccine  (Specification: ---b(4)----)
Method  ---b(4)---
Date of test  August 17, 2009
Result ---b(4)---

Identity test for Meningococcal AWY conjugate vaccine  (Specification: Positive)
Method  ---b(4)---
Date of test  August 13, 2009
Result  ---b(4)---

 

Test Method Specifications Date of Test Results
Identity for MenC Conjugate Vaccine ---b(4)--- ---b(4)---    
Identity for MenAWY Conjugate Vaccine ---b(4)--- ---b(4)---    
         

 

 

 MENINGOCOCCAL GROUP A CONJUGATE COMPONENT LOT ---------------

Name and address of manufacturer: Novartis Vaccines and Diagnostics ---b(4)---
Final lot: ---------------
Type of container: Vial
No. of final containers (after inspection): ---------------
No. of doses per final container: One
Volume of single human dose, after reconstitution
of Men A lyophilized conjugate component powder
with Men CWY liquid conjugate component:                      0.5 mL
Date of start period of validity:  ---------------
Expiry date: ---------------
Storage conditions of final product: 2 - 8° C, protected from light. Do not freeze

Result:   --b(4)---

Result:  --------------- mcg/mL

[          b(4)         ]

 

16 Pages determined to be not releasable:
b(4)

MEN A  FINAL BULK LOT  ---------------

Information on blending

Name and address of manufacturer: Novartis Vaccines and Diagnostics ----b(4)-----
Date of manufacturing:  ---------------

Men A - CRM conjugate component  

Conjugate concentrated bulk lot:  ---------------
Concentration:  --------------- mg/mL
Volume:  --------------- mL
 

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

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

Tests on final bulk

Sterility test  (Specification: Sterile)
Method:  --b(4)------.
Media:  FTM and SCDM
Volume tested:  --------------- mL
Date of test:  Record date beginning - date end
Result:  ---------------

 

MEN A LYOPHILIZED COMPONENT LOT  ---------------

Production details of final lot

Name and address of manufacturer:  Novartis Vaccines and Diagnostics --b(4)------KG
Lot of final bulk used in manufacture:  ---------------
Date of filling:  ---------------
Filled volume:  --------------- mL
Date of freeze-drying:  Record date beginning - date end
Storage conditions of final product:  2 - 8° C, protected from light. Do not freeze
 

Tests on final lot (*)

Identity test for MenA - CRM  (Specification: --b(4)------)
Method:  --b(4)------
Date of test:  ---------------
Result:  ---------------

Residual moisture  (Specification--b(4)------
Method:  --b(4)------
Date of test:  ---------------
Result:  --------------- %

Protein content  (Specification: --b(4)------
Method:  --b(4)------
Date of test:  ---------------
Result:  --------------- mcg/vial
 

(*) - Tests were performed at Novartis Vaccines and Diagnostics ---b(4)--- - Italy

Appearance of lyophilised plug  (Specification: --b(4)------)
Method: Visual examination
Date of test: ---------------
Result: ---------------

 

Appearance after reconstitution with WFI  (Specification: --b(4)------) (*)
Method: Visual examination
Date of test: ---------------
Result: ---------------
 

b(4)  (Specification: --b(4)------
Method: --b(4)------
Date of test:  ---------------
Result: ---------------

--b(4)------ content, -------b(4)-----------------------------------------------------------
Method:  --b(4)------
Date of test:  ---------------
Result:  --------------- mcg/vial
 

--b(4)------content, ---------------b(4)----------------------------------------------------------
Method:--b(4)------
Date of test:  ---------------
Result:  --------------- %
 

--b(4)------ content  (Specification: --b(4)------
Method:  --b(4)------
Date of test:  ---------------
Result:  --------------- mg/vial
 

Endotoxin content  (Specification: --b(4)------
Method:  -------b(4)-------------------------
Date of test:  ---------------
Result:  --------------- IU/vial

 (*) Reconstituted with Water for Injections.

Sterility test  (Specification: Sterile)
Method:  ---b(4)-----
Media used:  FTM and SCDM
No. of containers tested: ---------------
Date of test:  Record date beginning - date end
Result:  ---------------
 

General safety  (Specification: Non toxic) (*)
 
 

 

 
Method

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

---b(4)-----.
No. and type of animals injected

b(4) mice

2 guinea pigs
Weight of animals

b(4) – 22 g/animal

--b(4)-- g/animal
Route of injection

Intraperitoneally

Intraperitoneally
Volume of injection

0.5 mL

5.0 mL
Date of injection

---------------

---------------
Period of observation Date beginning - date end Date beginning - date end
Result

---------------

---------------

(*) Reconstituted with a lot of MenCWY liquid (i.e. tetravalent combination)

 

 32 Pages determined to be not releasable:
b(4)

 

Test on final bulk

Sterility test (Specification: Sterile)
Method:  ---b(4)----------
Media:  FTM and SCDM
Volume tested:  --------------- mL
Date of test:  Record date beginning - date end
Result:  ---------------

 

FINAL LOT  ---------------

Production details of final lot (*)
Name and address of manufacturer:  Novartis Vaccines and Diagnostics Srl, Bellaria - Rosia, 53018 Sovicille ---b(4)---(Italy)
Lot of final bulk used in manufacture:  ---------------
Date of filling: ---------------
Filled volume:  --------------- mL
Type of container:  Vial
No. of final containers (after inspection):  ---------------
Storage conditions of final product:  2 - 8° C, protected from light. Do not freeze
 

Tests on final lot

Identity test for MenC - CRM  (Specification: Positive)
Method:  -b(4)---
Date of test:  ---------------
Result:  ---------------
 

Identity test for MenW – CRM and MenY – CRM  (Specification: Positive)
Method:  -b(4)---
Date of test:  ---------------
Result:  ---------------

Appearance  (Specification: Colorless clear liquid)
Method:  Visual examination
Date of test:  ---------------
Result:  ---------------  

 (*) - Tests were performed at Novartis Vaccines and Diagnostics ---b(4)--- Italy

b(4)  (Specification: 6.7 - 7.7)
Method:  -b(4)---
Date of test:  ---------------
Result:  --------------- 

---b(4)------  (Specification: --b(4)-----------)
Method:  ---b(4)-----------------
Date of test:  ---------------
Result:  --------------- --b(4)----

Extractable volume  (Specification: -b(4)------)
Method:  --b(4)---------
Date of test:  ----------------
Result:  ---------------- mL

Men C --b(4)------, as sialic acid  (Specification: --b(4)----------)
Method:  --b(4)---------
Date of test:  ---------------
Result:  --------------- mcg/mL

Men C --b(4)------------------------------------ (Specification: -b(4)----
Method:  -b(4)--------
Date of test:  ---------------
Result:  --------------- %

Men W --b(4)------------------------------(Specification: ---b(4)---------)
Method:  --b(4)-------
Date of test:  ---------------
Result:  --------------- mcg/mL

Men W ---------b(4)-----------------------------------------------------------
Method:  --b(4)----------
Date of test:  ---------------
Result:  --------------- %

Men Y ----b(4)--------------------------------------------------------------------------------------
Method:  --b(4)---------
Date of test:  ---------------
Result:  --------------- mcg/mL
 

Men Y -----b(4)-----------------------------------------------------------------------------------
Method:  --b(4)--------
Date of test:  ---------------
Result:  --------------- %
 

Endotoxin content  (Specification: --b(4)-----------------
Method:  ---b(4)---------------------------
Date of test:  ---------------
Result:  --------------- IU/vial

Sterility test  (Specification: Sterile)
Method:  --b(4)------------------.
Media used:  FTM and SCDM
No. of containers tested:  ---------------
Date of test:  Record date beginning - date end
Result:  ---------------

 

General safety  (Specification: Non toxic)
 

 

 
Method --b(4)--------- --b(4)------
No. and type of animals injected b(4) mice 2 guinea pigs
Weight of animals -b(4)---animal

-b(4)-------/animal
Route of injection Intraperitoneally Intraperitoneally
Volume of injection 0.5 mL 5.0 mL
Date of injection --------------- ---------------
Period of observation Date beginning - date end Date beginning - date end
Result

---------------

---------------

(*) MenA lyophilized reconstituted with MenCWY liquid (i.e. tetravalent combination)  

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