Vaccines, Blood & Biologics
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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