About Diphtheria, Tetanus, and Pertussis Vaccines

There are 11 vaccines licensed for use in the United States by the Food and Drug Administration (FDA) to help protect against diphtheria and tetanus. Eight of these vaccines also help protect against pertussis. Some of the vaccines include protection against other diseases as well, including poliovirus, Haemophilus influenzae type b, and hepatitis B. Learn about the composition, types, immunogenicity, and efficacy of these vaccines, as well as view package inserts, below.

Types and Composition of Diphtheria, Tetanus, and Pertussis Vaccines

For protection against diphtheria and tetanus only, there is one vaccine (DT) that can be used in infants and children and two vaccines (Td) that can be used in patients 7 years of age or older. There are eight vaccines that help protect against diphtheria, tetanus, and pertussis. Six of these vaccines (DTaP) can be used in infants and children, while the other two (Tdap) are for use in patients 7 years of age or older.

Diphtheria and Tetanus Only Vaccines

There is one generic pediatric DT vaccine used in the United States.

Each 0.5-milliliter (mL) dose of DT (Sanofi Pasteur) is formulated to contain 6.7 limit of flocculation (Lf) of diphtheria toxoid, 5 Lf of tetanus toxoid, and not more than 0.17 milligram (mg) of aluminum. The residual formaldehyde content, by assay, is less than 0.02%. The vaccine is formulated without preservatives, but contains a trace amount of thimerosal from the manufacturing process [≤0.3 micrograms (μg) mercury/dose].

There are two Td vaccines used in the United States: Tenivac® and a generic.

Each 0.5-mL dose of Td (MassBiologics) is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Each 0.5-mL dose also contains aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 µg (0.02%) of residual formaldehyde, and a trace amount of thimerosal (< 0.3 µg mercury/dose) (not as a preservative) from the manufacturing process.

Each 0.5-mL dose of Tenivac® (Sanofi Pasteur) contains the following active ingredients: 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Other ingredients per 0.5-mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 µg of residual formaldehyde.

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Diphtheria, Tetanus, and Pertussis (DTaP) Vaccines

There are six pediatric DTaP vaccines used in the United States: Daptacel®, Infanrix®, Kinrix®, Pediarix®, Pentacel®, and Quadracel®.

Each 0.5-mL dose of Daptacel® (Sanofi Pasteur) contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, and acellular pertussis antigens [10 µg detoxified pertussis toxin (PT), 5 µg filamentous hemagglutinin (FHA), 3 µg pertactin, and 5 µg fimbriae types 2 and 3 (FIM)]. Other ingredients per 0.5-mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤5 µg residual formaldehyde, <50 nanogram (ng) residual glutaraldehyde and 3.3 mg [0.6% volume per volume (v/v)] 2-phenoxyethanol (not as a preservative).

Each 0.5-mL dose of Infanrix® (GlaxoSmithKline) is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 µg of inactivated PT, 25 µg of FHA, and 8 µg of pertactin (69 kiloDalton outer membrane protein). Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.625 mg aluminum by assay) and 4.5 mg of sodium chloride. Each dose also contains ≤100 µg of residual formaldehyde and ≤100 µg of polysorbate 80 (Tween 80).

Each 0.5-mL dose of Kinrix® (GlaxoSmithKline) includes the same diphtheria, tetanus, and pertussis components listed in Infanrix® above, and includes 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.6 mg aluminum by assay) and 4.5 mg of sodium chloride. Each dose also contains ≤100 µg of residual formaldehyde and ≤100 µg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose.

Each 0.5-mL dose of Pediarix® (GlaxoSmithKline) includes the same diphtheria, tetanus, and pertussis components listed in Infanrix® above, the poliovirus components listed in Kinrix® above, and 10 µg of hepatitis B virus surface antigen (HBsAg). Each 0.5-mL dose contains aluminum salts as adjuvant (not more than 0.85 mg aluminum by assay) and 4.5 mg of sodium chloride. Each dose also contains ≤100 µg of residual formaldehyde and ≤100 µg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B are used in the poliovirus 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.

Each 0.5-mL dose of Pentacel® (Sanofi Pasteur) contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens (20 µg detoxified PT, 20 µg FHA, 3 µg pertactin, 5 µg FIM), inactivated polioviruses [40 DU Type 1 (Mahoney), 8 DU Type 2 (MEF-1), 32 DU Type 3 (Saukett)], and 10 µg polyribosyl-ribitol-phosphate (PRP) of H. influenzae type b covalently bound to 24 µg of tetanus toxoid (PRP-T). Other ingredients per 0.5-mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, polysorbate 80 (approximately 10 parts per million by calculation), 42.5 mg sucrose, ≤5 µg residual formaldehyde, <50 ng residual glutaraldehyde, ≤50 ng residual bovine serum albumin, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), <4 picogram (pg) of neomycin, and <4 pg polymyxin B sulfate.

Each 0.5-mL dose of Quadracel® (Sanofi Pasteur) contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens (20 µg detoxified PT, 20 µg FHA, 3 µg pertactin, 5 µg FIM), and inactivated polioviruses [40 DU Type 1 (Mahoney), 8 DU Type 2 (MEF-1), 32 DU Type 3 (Saukett)]. Other ingredients per 0.5-mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, polysorbate 80 (approximately 10 parts per million by calculation), ≤5 µg residual formaldehyde, <50 ng residual glutaraldehyde, ≤50 ng residual bovine serum albumin, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), <4 pg of neomycin, and <4 pg polymyxin B sulfate. Quadracel® does not contain a preservative.

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Tetanus, Diphtheria, and Pertussis (Tdap) Vaccines

There are two Tdap vaccines used in the United States: Adacel® and Boostrix®.

Each 0.5-mL dose of Adacel® (Sanofi Pasteur) contains 5 Lf tetanus toxoid, 2 Lf diphtheria toxoid, and acellular pertussis antigens (2.5 µg detoxified PT, 5 µg FHA, 3 µg pertactin, 5 µg FIM). Other ingredients per 0.5-mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 µg residual formaldehyde, <50 ng residual glutaraldehyde, and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative).

Each 0.5-mL dose of Boostrix® (GlaxoSmithKline) is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 µg of inactivated PT, 8 µg of FHA, and 2.5 µg of pertactin (69 kiloDalton outer membrane protein). Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.39 mg aluminum by assay), 4.5 mg of sodium chloride, ≤100 µg of residual formaldehyde, and ≤100 µg of polysorbate 80 (Tween 80).

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Immunogenicity and Vaccine Efficacy

Today, diphtheria and tetanus are at historic low rates in the United States. Efficacy of tetanus toxoid and diphtheria toxoid have never been studied in a vaccine trial, but they can be inferred from protective antitoxin levels. A complete series (which is defined as 3 doses for people 7 years or older and 4 doses for children younger than 7) is estimated to have a clinical efficacy of virtually 100% for tetanus and 97% for diphtheria.

In regard to pertussis, there has been an overall increasing trend in reported cases since the 1980s. In spite of this trend, many fewer people are affected by pertussis today than before pertussis-containing vaccines became widely available in the 1940s. There are several reasons to help explain why we are seeing more cases recently, including increased awareness, improved diagnostic tests, better reporting, more circulation of the bacteria, and waning immunity. When it comes to waning immunity, it seems that the acellular pertussis vaccines we use now may not protect for as long as the whole cell pertussis vaccine we used in the past. Molecular changes to Bordetella pertussis may also be contributing to the resurgence.

In studies demonstrating the efficacy of the pertussis component of DTaP:

• 98% of children who get all 5 doses of DTaP on schedule are fully protected against pertussis within the year following the last dose.
• About 71% of children who get all 5 doses of DTaP on schedule are fully protected against pertussis 5 years after getting the last dose of DTaP.

In studies demonstrating the efficacy of the pertussis component of Tdap:

• About 73% of adolescents are fully protected against pertussis in the first year after vaccination.
• About 34% of people are fully protected against pertussis 4 years after vaccination.

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Package Inserts

Consult the following package inserts for proper storage and handing details, shelf life, and reconstitution instructions:

• Adacel®
• Boostrix®
• Daptacel®
• DT Generic
• Infanrix®
• Kinrix®
• Pediarix®
• Pentacel® [36 pages]
• Quadracel®
• Td Generic [6 pages]
• Tenivac® [21 pages]

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References

• Acosta AM, DeBolt C, Tasslimi A, et al. Tdap vaccine effectiveness in adolescents during the 2012 Washington state pertussis epidemic. Pediatrics. 2015;135:981–9.
• Tartof SY, Lewis M, Kenyon C, et al. Waning immunity to pertussis following 5 doses of DTaP. Pediatrics. 2013;131:e1047–52.
• Misegades LK, Winter K, Harriman K, at al. Association of childhood pertussis with receipt of 5 doses of pertussis vaccine by time since last vaccine dose, California, 2010. JAMA. 2012;308:2126–32.
• Vitek CR, Wharton M. Diphtheria toxoid. In Plotkin SA, Orenstein WA, Offit, PA, eds. Vaccines. 5th ed. China: Saunders, 2008:139-56.
• Wassilak SGF, Roper MH, Kretsinger K, Orenstein WA. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines. 5th ed. China: Saunders, 2008:805–39.

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