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Vaccines, Blood & Biologics

Analytical Test Method Validation Report, February 15, 2010 - Menveo

DATE:  15 February 2010
TO:   Willie F. Vann, Ph.D., Chairman
FROM: Milan S. Blake, Ph.D., Director, DBPAP
SUBJECT: Novartis Meningococcal ACWY Conjugate Vaccine
STN 125300
Analytical Test Method Validation Report:  Serum bactericidal assay for the determination of complement fixing antibodies against Neisseria meningitidis Serougroups A, C, W-135, Y
THROUGH:   Norman W. Baylor, Ph.D., Director, OVRR


Norvartis Vaccines and Diagnostics (NVD) submitted as part of their BLA which seeks licensure for use of a meningococcal quadravalent (A, C, Y, and W135) polysaccharide conjugate vaccine in individuals aged 11 to 55 years, a validation report, Document No. 231439-02, for a serum bactericidal assay.   The assay determines the level of complement fixing antibodies against Neisseria meningitidis serogroups A, C, W-135, and Y (hSBA validation report) for NVD Meningococcal ACWY Conjugate Vaccine ( MenACWY).  This validation report was previously reviewed under BB-IND -b(4)- with minor changes.  The hSBA validation report was requested by the Agency in facsimiles dated 29 and 30 August 2005 under the IND and submitted for advice and comment on 5 January 2006.  The report was referenced in the responses to the 29 and 30 August 2005 FDA Letters submitted on 16 December 2005 (Serial Number -b(4)-). NVD responded to an OVRR letter of 30 May 2006 on 6 July 2006.  A technical meeting with representatives of NVD and DBPAP occurred on 25 April 2007 following the end of Phase II meeting. 

Validation Report Review

The principle of the Serum Bactericidal Assay (SBA) is based on the antibody-dependent complement mediated lysis of Neisseria meningitidis target strains (Serogroups A, C, W-135, and Y) by antibodies in serum samples.  The validation was performed to evaluate the reliability of the SBA with respect to its use in routine testing of sera from clinical trials.  The assay is used to evaluate the immune response before and after vaccination with tetravalent meningococcal vaccines.  The antibody titer following vaccination serves as marker for the immunogenicity of

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The data presented in the validation report Doc. No.231439 demonstrates that the assay as performed using SOP No. 222582 in determining the level of complement fixing antibodies against Neisseria meningitidis serogroups A, C, W-135, and Y has repeatability, intermediate precision, linearity, specificity, and detection and quantitation limits.  From my review, these assays are valid for there intended use.

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