
Assay Review Memo, January 7, 2010 - MenHibrix


 
 
Department of Health and Human Services

Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research


Memorandum

Date:               January 7, 2010

From:               Steven A. Rubin, OVRR, DVP, HFM-460

Subject:           Review of GSK's 125363: MENHIBRIX (Meningococcal Groups C and Y and
Haemophilus b Tetanus Toxoid Conjugate Vaccine)

To:                   Joseph Temenak, DVRPA, HFM-478

Cc:                   Robin Levis, PhD., Deputy Director, DVP
Meghan Ferris, MD, MPH, Clinical Reviewer, DVRPA

 

Summary:

The present application provides information to support the use of MenHibrix, a lyophilized vaccine containing tetanus toxoid-bound bacterial polysaccharides derived from N. meningitidis (serogroups C and Y) and H. influenzae type b, in persons 6 weeks to 15 months of age.

Because MMR and varicella vaccines are administered at the same vaccination visit in children who will be eligible for MenHibrix vaccination, the sponsor conducted studies to assess possible interference between MenHibrix and MMR and between MenHibrix and Varivax.

This review is limited to an evaluation of the sponsor’s serological assays for measuring levels of anti-measles, anti-mumps, and anti-rubella antibodies in serum drawn from children post vaccination.

Anti-measles, anti-mumps, and anti-rubella antibody assays

Anti-measles and anti-rubella antibodies are measured using commercially purchased --------------------(b)(4)----------. Anti-mumps virus antibodies are measured by in --------(b)(4)----------------------------------------. The SOP and validation reports for these assays are identical to those reviewed and approved by CBER for IND (b)(4), the sponsor’s investigational -----------------------------------(b)(4)----------------------------------------------------------------. Therefore, these assays are considered valid for use in support of the MenHibrix vaccine.

Comments to relay to the sponsor:


None

Internal Comments:

Based on prior discussions with the sponsor, seroresponse using these assays was defined as:
1.---------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------.

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

These definitions were agreed upon in association with IND (b)(4), and have been reiterated in this BLA (125363). However, I note that these cutoffs are not consistently used in evaluating the immunogenicity data obtained in clinical studies 008 (Hib-MenCY-TT-008 BST:007) and 010 (Hib-MenCY-TT-010 BST: 009). Only the above definitions of seroresponse should be considered in assessments of non-interference of MenHibrix with MMR immune responses.
