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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1/9/2008 Review/Approval Recommendation

Public Health Service
Center for Biologics Evaluation and Research
Division of Bacterial Products
Laboratory of Methods Development and Quality Control

Internal Memorandum


Date: January 9, 2008
From: Juan L. Arciniega, D.Sc. (HFM-443)
Subject: Review/Approval Recommendation of BLA STN# 125260: "GlaxoSmithKline's (GSK) Diphtheria & Tetanus Toxoids, Acellular Pertussis Vaccine Adsorbed & Inactivated Poliovirus Vaccine (DTaP-IPV/KinrixT)"
To: Michael Schmitt, Ph.D. (HFM-434)
Committee Chairperson
Through: Drusilla L. Burns, Ph.D. (HFM-443)
Acting Chief, LMDQC

I reviewed section 3.2.S.4 (control of drug substance: acellular pertussis component) and the portions of section 3.2.P.5. (control of drug product) relative to the acellular pertussis component of STN 125260 (original submission dated April 6, 2007). Because most of the manufacturing and testing of the drug substances contained in the drug product under review are equivalent to those used to prepare and test components included in other GSK products licensed in the US, I have limited my in depth review to those tests or procedures that are specific for the product under consideration. In particular, I have focused my attention on assay design matters, including validation and acceptance criteria.

In a teleconference with GSK's representatives held on November 21, 2007, I discussed the questions arising from my review. GSK submitted responses to my questions in writing on December 20, 2007. Aside from adequate clarifications, GSK modified acceptance criteria for the potency testing of the acellular pertussis component of KinrixT on the basis of my concerns. GSK decided to remove, from the dataset used for the calculation of the acceptance criteria, immunogenicity results obtained when testing DTaP-IPV in combination with Hib. The new dataset consisted of the results obtained from all US clinical and commercial scale lots of DTaP-IPV (n = 14) and all non-US commercial lots of DTaP-IPV manufactured to the date of the response, and since de manufacturing of the lots tested in US Phase II clinical studies (n = 142).

Using the same algorithm used in the original submission, GSK proposed the following relative responses as acceptance criteria for the immunogenicity (potency) of the pertussis component:


In my opinion, this change in limits is appropriate.

Because GSK's has satisfactorily addressed all my concerns, I recommend the approval of STN# 125260.

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