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Tripedia®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP), for intramuscular use, is a sterile preparation of diphtheria and tetanus toxoids adsorbed, with acellular pertussis vaccine in an isotonic sodium chloride solution containing sodium phosphate to control pH. After shaking, the vaccine is a homogeneous white suspension. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is distributed by Aventis Pasteur Inc. (AvP).

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.¹ Clostridium tetani cultures are grown in a peptone-based medium containing a bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration.

The acellular pertussis vaccine components are isolated from culture fluids of Phase 1 Bordetella pertussis grown in a modified Stainer-Scholte medium.² After purification by salt precipitation, ultracentrifugation, and ultrafiltration, preparations containing varying amounts of both pertussis toxin (PT) and filamentous hemagglutinin (FHA) are combined to obtain a 1:1 ratio and treated with formaldehyde to inactivate PT.

The diphtheria and tetanus toxoids are adsorbed using aluminum potassium sulfate (alum). The adsorbed toxoids are combined with acellular pertussis concentrate, and diluted to a final volume using sterile phosphate-buffered physiological saline.

Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test), and 46.8 mg of pertussis antigens. This is represented in the final vaccine as approximately 23.4 mg of inactivated PT and 23.4 mg of FHA. The inactivated acellular pertussis component contributes not more than 50 endotoxin units to the endotoxin content of 1 mL of DTaP. The potency of the pertussis components is evaluated by measuring the antibody response to PT and FHA in immunized mice using an ELISA system. The vaccine is formulated without preservatives, but contains a trace amount of thimerosal [(mercury derivative), (≤0.3 mg mercury/dose)] from the manufacturing process. Each 0.5 mL dose also contains, by assay, not more than 0.170 mg of aluminum and not more than 100 mg (0.02%) of residual formaldehyde. The vaccine contains gelatin and polysorbate 80 (Tween-80), which are used in the production of the pertussis concentrate.

Acellular Pertussis Vaccine Concentrates (For Further Manufacturing Use) are produced by The Research Foundation for Microbial Diseases of Osaka University (BIKEN), Osaka, Japan, under United States (US) license, and are combined with diphtheria and tetanus toxoids manufactured by AvP. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is filled, labeled, packaged, and released by AvP.

When Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is used to reconstitute ActHIB[Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) manufactured by Aventis Pasteur SA] the combination vaccine is TriHIBit. Each single 0.5 mL dose of TriHIBit vaccine for the fourth dose only, is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test), 46.8 mg of pertussis antigens (approximately 23.4 mg of inactivated PT and 23.4 mg of FHA), 10 mg of purified Haemophilus influenzae type b capsular polysaccharide conjugated to 24 mg of inactivated tetanus toxoid, and 8.5% sucrose. (Refer to ActHIB vaccine package insert.)

REFERENCES

1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 1941;40: 21-32.

2. Aventis Pasteur Inc. , Data on File 072503.

Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.