Licensure of a DTaP-IPV Vaccine - KINRIX

MEMORANDUM

DATE: January 27, 2008

FROM: Ronald Lundquist, Ph.D., OVRR/DVP/LMD

SUBJECT: BLA 125260
Licensure of a DTaP-IPV Vaccine

THROUGH: Konstantin Chumakov, Ph.D., OVRR/DVP/LMD

TO: The File

Recommendation: I recommend licensure of Kinrix, as described in BLA 125260.

I. Introduction-

GlaxoSmithKline Biologicals, S.A.(GSK), submitted BLA 125260, seeking approval for a United States license for Kinrix, their DTaP-IPV combination vaccine (diptheria and tetanus toxoids, acellular pertussis, absorbed, and inactivated poliovirus vaccine (IPV), combined) for the active immunization of children 4-6 years of age. This vaccine is intended to provide a fourth dose of IPV and a fifth dose of DTaP. Kinrix is fully preservative-free and does not contain either thimerosal or 2-phenoxyethanol (2-PE). Kinrix therefore differs from GSK's DTaP-IPV manufactured for other countries ( more than --------- lots to date), which contains 2-PE. The DTaP and IPV components of Kinrix are the same as those found in GSK's Pediarix (DTaP, IPV, and Hepatitis B (recombinant), combined), which was previously approved for use in the United States ( STN 103907, approved December 13, 2002). A single 0.5 ml dose of Kinrix will be administered in the deltoid muscle. Each dose contains------- of aluminum hydroxide as adjuvant, as does Pediarix. Kinrix is formulated to contain, per dose, 40/8/32 D units of Type 1 (Mahoney strain), Type 2 (MEF-1 strain), and Type 3 (Saukett strain) poliovirus antigens. The following review comments are focused on the IPV component of Kinrix.

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