Status: withdrawn from market

Organizations involved:

Sanofi Pasteur Inc. – Former

Sanofi Pasteur S.A. – Parent; Former.

Cross ref: See the entries for Diphtheria and Pertussis Toxoids and Pertussis Vaccine (DTP/DTaP) Products (#429); Tetanus Toxoid Products (#480); and Diphtheria Toxoid Products (#418). See the entries for the components of this DTP vaccine – Diphtheria & Tetanus Toxoids Adsorbed (#423), and Pertussis Vaccine (#509), both from Sanofi Aventis Inc.; and for the individual diphtheria and tetanus toxoids components.

Description: Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed or DTP vaccine is a aqueous formulation containing an aqueous mixture of two vaccines – Diphtheria & Tetanus Toxoids Adsorbed (DT vaccine), with both toxoids adsorbed using aluminum potassium sulfate (alum); and Pertussis Vaccine Adsorbed, a whole-cell pertussis vaccine. The vaccines are combined in a sterile isotonic sodium chloride solution containing sodium phosphate buffer to control pH.

This DTP vaccine is packaged in 7.5 mL multiple dose vials. Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid (and both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test). Each 0.5 mL dose contains, by assay, not more than 0.17 mg of aluminum and not more than 100 µg (0.02%) of residual formaldehyde. Thimerosal (mercury derivative; see #939) 1:10,000 is present as an antimicrobial preservative. The vaccine is stored between 2-8°C (35-46°F; refrigerated).

Besides use as a DTP vaccine, this vaccine was also used to reconstitute Haemophilus b conjugate vaccines, e.g., ActHIB, to form a DTP & HIB vaccine, i.e., the DTP vaccine was used to reconstitute/dissolve the lyophilized Haemophilus vaccine to provide a quadravalent vaccine.

Nomenclature: DTP Vaccine/Aventis [BIO]; Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP (For Pediatric Use) [FDA]; DTP vaccine [SY]; NDC 49281-280-84 [NDC]

Companies.: The vaccine was manufactured by Aventis Pasteur Inc. (now Sanofi Aventis Inc.), FDA CBER est. no. 0073. It was marketed in the U.S. by Aventis Pasteur Inc.; and, perhaps, internationally by Aventis Pasteur S.A. (parent company; now Sanofi Pasteur S.A.) affiliates. Aventis merged into Sanofi Aventis S.A. in late 2004.

Manufacture: See the entries for component vaccines. The adsorbed bivalent diphtheria and tetanus toxoids (DT) vaccine is combined with non-adsorbed pertussis vaccine concentrate, and diluted to a final volume using sterile phosphate-buffered physiological saline.

FDA class: Biologic PLA

CBER class: Multiple Antigen Preparations

Approvals: Date = 19490516; first approval; granted to Merrell-National Labs., Richardson-Merrell Inc.

Date = 19780103; licenses revoked and granted (reissued) to new owner, Connaught Labs., Inc.

Date = 19991209; approval revoked from Connaught Labs. and granted (reissued) to new owner, Aventis Pasteur Inc.

Indications: [brief portion of the "INDICATIONS AND USAGE” section from the product insert/labeling]:

Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP (For Pediatric Use) is recommended for active immunization of children up to age 7 years against diphtheria, tetanus, and pertussis (whooping cough) simultaneously.

Status: No longer on FDA approval lists. Approval was voluntarily withdrawn.