Pediarix components

Pediarix components are similar to Pentacel components. Single-dose, prefilled syringes containing a 0.5-mL suspension for injection.

Pediarix components are:

  • Diphtheria toxoid
  • Tetanus toxoid
  • Inactivated pertussis toxin (PT)
  • Filamentous hemagglutinin (FHA),
  • Pertactin
  • HBsAg (Hepatitis B surface antigen)
  • Type 1 poliovirus (Mahoney),
  • Type 2 poliovirus (MEF-1),
  • Type 3 poliovirus (Saukett).

The diphtheria, tetanus, and pertussis components are the same as those in Infanrix and Kinrix. The hepatitis B surface antigen is the same as that in Engerix-B.

Each 0.5-mL dose also contains:

  • Aluminum salts as adjuvant
  • Sodium chloride
  • Residual formaldehyde
  • Residual polysorbate 80
  • Neomycin sulfate
  • Polymyxin B
  • Yeast protein

Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] is a noninfectious, sterile vaccine for intramuscular administration.

The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract.

Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein.

Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.

The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. 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 is obtained by culturing genetically engineered Saccharomyces cerevisiae (S. 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 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.

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.

Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The hepatitis B component is adsorbed onto aluminum phosphate.

Pediarix is formulated without preservatives.

Source:
https://www.fda.gov/media/79830/download

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