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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Chemicals Manufacturing and Controls (CMC) Review

BLAS/STN Number: 125260/0
BLAS Sponsor: GSK
BLAS Product: Kinrix
BLAS Purpose: Introduction of new DTaP-IPV vaccine
To: File
From: Gennady Rezapkin
Thru: Konstantin Chumakov
Memo Date: December 21, 2007
Revision Date: December 21, 2007

Signature:


The candidate DTaP-IPV vaccine is a combination of well-known antigens. All components of the vaccine have been previously studied and licensed for use. The DTaP-IPV candidate vaccine (Kinrix) contains the following active ingredients per single dose (0.5 ml): 25 Lf of diphtheria toxoid (D), 10 Lf of tetanus toxoid (T), 25 µg of detoxified pertussis toxin (PT), 25 µg of formalin-treated filamentous haemagglutinin (FHA), 8 µg of formalin-treated Pertactin [PRN-Outer Membrane Protein (69K)], 40 units of D-antigen for poliovirus type 1 (Mahoney strain), 8 units of D-antigen for poliovirus type 2 (MEF-1 strain), and 32 units for D-antigen for poliovirus type 3 (Saukett strain).

The subject of this review is Chemicals Manufacturing and Controls (CMC) of Inactivated Poliovirus Vaccine (IPV) component of Kinrix.

The IPV component used to formulate DTaP-IPV candidate vaccine is exactly the same as used in the formulation of GSK's US licensed Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; STN 103907, approved December 13, 2002]. All information about IPV production have been previously submitted and approved by CBER under the Pediarix BLA.

The main changes in production of IPV component of Kinrix include:

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Overall conclusion: 

The application can be approved in the part related to the Chemical Manufacturing and Controls IPV component DTaP-IPV vaccine, Kinrix.


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