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About Diphtheria, Tetanus, and Pertussis Vaccines

One of the Recommended Vaccines

The Food and Drug Administration (FDA) licensed 11 vaccines for use in the United States 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 poliomyeltis, Haemophilus influenzae type b disease, and hepatitis B. Learn about the composition, types, immunogenicity, and efficacy of these vaccines, as well as view package inserts, below.

Pink Book

Pink Book.

The “Pink Book” contains the most comprehensive information on routinely used vaccines and the diseases they prevent.

Six reference appendices include: vaccine minimum ages and intervals, current and discontinued vaccines, vaccine contents, foreign vaccine terms, and more.

View online or download.

Types and Composition of Diphtheria, Tetanus, and Pertussis Vaccines

Diphtheria and Tetanus (DT and Td) Only Vaccines

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

Each 0.5-milliliter (mL) dose of DT (Sanofi Pasteur) contains 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 contains a trace amount of thimerosal (not as a preservative) 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) contains 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) contains 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). The manufacturing process of the poliovirus vaccine uses neomycin sulfate and polymyxin B. Those ingredients 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). The manufacturing process of the poliovirus vaccine uses neomycin sulfate and polymyxin B. Those ingredients 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) contains 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. No one has ever studied the efficacy of tetanus toxoid and diphtheria toxoid in a vaccine trial. However experts infer efficacy from protective antitoxin levels. A complete vaccine series has a clinical efficacy of virtually 100% for tetanus and 97% for diphtheria. A complete series is 3 doses for people 7 years or older and 4 doses for children younger than 7.

In regard to pertussis, there has been an overall increasing trend in reported cases since the 1980s. In spite of this, pertussis affects many fewer people 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:

  • Increased awareness
  • Improved diagnostic tests
  • Better reporting
  • More circulation of the bacteria
  • Waning immunity

The acellular pertussis vaccines now used in the United States do not protect for as long as the prior whole cell pertussis vaccine. CDC is looking into whether molecular changes to may also be contributing to the resurgence.

In studies demonstrating the efficacy of the pertussis component for children who get all 5 doses on schedule, DTaP fully protects:

  • 98% of children within the year following the last dose
  • About 71% of children 5 years after getting the last dose of DTaP

In studies demonstrating the efficacy of the pertussis component, Tdap fully protects:

  • About 73% of adolescents in the first year after vaccination
  • About 34% of people 4 years after vaccination

In studies demonstrating the efficacy of the pertussis component when women get Tdap during pregnancy, the vaccine prevents:

  • About 78% of pertussis cases in infants younger than 2 months old
  • About 90% of hospitalizations for infants younger than 2 months old with pertussis

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Package Inserts

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

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References

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