[Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined]
PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] is a noninfectious, sterile, multivalent vaccine for intramuscular administration manufactured by GlaxoSmithKline Biologicals. It contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). The diphtheria toxoid, tetanus toxoid, and pertussis antigens are the same as those in INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). The hepatitis B surface antigen is the same as that in ENGERIX-B® [Hepatitis B Vaccine (Recombinant)].
The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovineextract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.
The 3 acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.
The hepatitis B surface antigen (HBsAg) is obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic medium. The surface antigen expressed in the S. cerevisiae cells is purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration.
The inactivated poliovirus component of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate.
The diphtheria, tetanus, and pertussis antigens are individually adsorbed onto aluminum hydroxide; hepatitis B component is adsorbed onto aluminum phosphate. All antigens are then diluted and combined to produce the final formulated vaccine. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated PT, 25 mcg of FHA, 8 mcg of pertactin, 10 mcg of HBsAg, 40 D-antigen Units (DU) of Type 1 poliovirus, 8 DU of Type 2 poliovirus, and 32 DU of Type 3 poliovirus.
Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde-treated FHA and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Potency of the hepatitis B component is established by HBsAg ELISA. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus neutralizing cell culture assay on sera from previously immunized rats.
Each 0.5-mL dose also contains 4.5 mg of NaCl and aluminum adjuvant (not more than 0.85 mg aluminum by assay). Each dose also contains ≤ 100 mcg of residual formaldehyde and ≤ 100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B are used in the polio vaccine manufacturing process and may be present in the final vaccine at ≤ 0.05 ng neomycin and 0.01 ng polymyxin B per dose. The procedures used to manufacture the HBsAg antigen result in a product that contains ≤ 5% yeast protein.
PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is formulated without preservatives.
The vaccine must be well shaken before administration to obtain a homogeneous, turbid, white suspension.
Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) is manufactured by Novartis Vaccines and Diagnostics GmbH & Co. KG, Marburg, Germany. The acellular pertussis antigens, the hepatitis B surface antigen, and the inactivated poliovirus antigens are manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium. Formulation, filling, testing, packaging, and release of the vaccine are performed by GlaxoSmithKline Biologicals.
Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.
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