Poliovirus Vaccine Inactivated; IPV
Status: component of a combination vaccine
Organizations involved:
GlaxoSmithKline Biologicals S.A.– Manuf.; R&D; Tech.; Intl. mark.
GlaxoSmithKline Inc. – USA mark.
GlaxoSmithKline plc – Parent co.
Cross ref.: See the entry for DTaP & Hepatitis B & Polio Vaccine or Pediarix (#441), a combination vaccine including this vaccine as a component. See the entries for Polio Vaccine Products (#516) and other inactivated poliovirus vaccines (only one is marketed in the U.S.).
Description: Poliovirus Vaccine Inactivated, a component of Pediarix, is an aqueous suspension of three inactivated strains of poliovirus – Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett) – cultured in Vero cells, a continuous African green monkey kidney cell line, using microcarrier culture methods. This inactivated poliovirus component of Pediarix is an enhanced potency component, with a dose of Pediarix containing 40 D-antigen Units (DU) of Type 1 poliovirus, 8 DU of Type 2 poliovirus, and 32 DU of Type 3 poliovirus. Potency is determined using the D-antigen ELISA and by a poliovirus neutralizing cell culture assay on sera from previously immunized rats.
Nomenclature: Poliovirus Vaccine (IPV)/GSK [BIO]; Poliovirus Vaccine Inactivated [FDA]; Poliomyelitis Vaccine [FDA former]; IPV [SY CDC]
Companies.: The three component polioviruses and the formulated inactivated vaccine containing these are manufactured by GlaxoSmithKline Biologicals (Rixensart, Belgium), CBER/FDA est. no. 1617., a subsidiary of GlaxoSmithKline plc. Th vaccine is approved by FDA exclusively for further manufacture of Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined or Pediarix.
Manufacture: Each of the three strains of poliovirus is individually cultured in Vero cells. Calf serum and lactalbumin hydrolysate are used during Vero cell culture. Calf serum used for independent culture of each virus strain is sourced from USDA-designated BSE-free countries. After clarification of the culture media, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde (or perhaps more accurately, formalin or formaldehyde gas in aqueous solution). The three purified viral strains are then pooled to form trivalent concentrate.
Approvals: Date = 20021213; first approval as a component of a combination vaccine (Pediarix)
Status: This inactivated poliovirus vaccine (IPV) has been approved and is only available in the U.S. as a component of a pentavalent vaccine, DTaP & Hepatitis B & Polio Vaccine (Pediarix). The same poliovirus vaccine is marketed by GlaxoSmithKline separately and as a component of other combination vaccines in Europe and internationally.
Companies involvement:
Full monograph
520 Poliovirus Vaccine (IPV)/GSK
Nomenclature:
Poliovirus Vaccine (IPV)/GSK [BIO]
Poliovirus Vaccine Inactivated [FDA]
Poliomyelitis Vaccine [FDA former]
IPV [SY]
FDA Class: Biologic BLA
Year of approval (FDA) = 2002
Date of 1st FDA approval = 20021213
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
bovine materials used<!-- bovinesource -->
monkey source materials
vaccines, inactivated
vaccines, viral
adw, hepatitis B virus subtype
bovine serum
kidney cells, human neonatal
lacI9 gene (Amersham)
mammalian cell culture
microcarrier culture
monkey kidney cells<!-- monkeycells -->
Vero cells
formaldehyde
North American coral snake
North American coral snake
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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