Diphtheria and Tetanus Toxoids Adsorbed, Tetanus and Diphtheria Toxoids Adsorbed

Class: Toxoids
ATC Class: J07AF01
VA Class: IM105
Brands: Decavac

Introduction

Fixed-combination preparations containing formaldehyde-treated tetanus and diphtheria toxins (toxoids) adsorbed onto aluminum adjuvants.^{100 113 114 164} The toxoids are used to stimulate active immunity to diphtheria and tetanus.^{100 113 114 164} Commercially available as diphtheria and tetanus toxoids adsorbed (DT) and tetanus and diphtheria toxoids adsorbed (Td).^{113 114 164} DT contains a higher dose of diphtheria toxoid than Td.^{113 114 164} Single-antigen preparation containing tetanus toxoid adsorbed also commercially available.¹⁴⁰

Uses for Diphtheria and Tetanus Toxoids Adsorbed, Tetanus and Diphtheria Toxoids Adsorbed

Prevention of Diphtheria and Tetanus

DT is used to prevent diphtheria and tetanus in infants and children 6 weeks through 6 years of age.^{100 114} Td is used to prevent diphtheria and tetanus in adults, adolescents, and children ≥7 years of age.^{113 164}

Diphtheria is caused by toxigenic strains of Corynebacterium diphtheriae or, rarely, toxigenic strains of C. ulcerans.^{100 101 115 119 132 133 145 161} The overall case-fatality rate for diphtheria is 5–10% with higher death rates (up to 20%) among individuals <5 years of age and >40 years of age.^{119 162} Diphtheria is uncommon in the US, but toxigenic strains of Corynebacterium continue to circulate in areas of the US where the disease previously was endemic.^{100 101 119 161} Diphtheria continues to circulate worldwide and is endemic in many countries in Africa, Latin America, Asia/South Pacific, the Middle East, and Russia and surrounding countries.^{100 101 119} Consult the CDC website () for information regarding where diphtheria is endemic.¹¹⁵ Before widespread immunization against diphtheria was initiated in the 1940s, there were approximately 100,000–200,000 cases of diphtheria and 13,000–15,000 diphtheria-related deaths each year in the US.¹¹⁹ Most cases of diphtheria occur in individuals who are unvaccinated or incompletely vaccinated against the disease.^{100 101 119}

Tetanus is a potentially fatal disease caused by a neurotoxic exotoxin (tetanospasmin) produced by Clostridium tetani.^{101 113 114 115 119} C. tetani spores are ubiquitous in the environment worldwide and are found in soil and in animal (e.g., horses, sheep, cattle, dogs, cats, rats, guinea pigs, chickens) and human intestinal tracts.^{100 101 114 115 119 132} The spores can contaminate open wounds, especially puncture wounds or those with devitalized tissue; anaerobic wound conditions allow the spores to germinate and produce exotoxins that disseminate through the blood and lymphatic system.^{101 119 132} Neonatal tetanus (tetanus neonatorum) occurs in infants born under nonsterile conditions to women inadequately vaccinated against tetanus; infection usually involves a contaminated umbilical stump and occurs because infant does not have passively-acquired maternal antibodies against tetanus.^{100 101 113 115 119 132 145} Obstetric tetanus occurs within 6 weeks after delivery or termination of pregnancy because of contaminated wounds or abrasions or unclean deliveries or abortions.¹⁴⁵ Generalized tetanus is characterized by rigidity and convulsive muscle spasms that usually involve the jaw (lockjaw) and neck and then become generalized.^{101 113 115 119 132} Tetanus occurs worldwide, almost exclusively in individuals who are unvaccinated or inadequately vaccinated against the disease.^{101 115} An average of 31 cases reported each year in the US from 2000 through 2007 (case fatality rate 10%);¹¹⁹ a low of 20 cases reported in 2003.¹¹⁹ Most cases of tetanus in the US occur following acute injuries or wounds (puncture wounds, lacerations, abrasions)^{119 126} and usually occur in adults ≥40 years of age; however, an increase in the disease has been reported recently in younger adults (e.g., heroin abusers).^{119 126} Tetanus is not transmitted person-to-person.^{115 119}

Slideshow: Grapefruit and Medicines: A Possible Deadly Mix?

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all individuals be immunized against diphtheria and tetanus and also immunized against pertussis.^{100 101 132 133 135 145 199 200} Use of a combination vaccine generally is preferred over separate injections of equivalent component vaccines;^{163 199} considerations include provider assessment (e.g., number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, storage requirements, cost), patient preference, and potential for adverse effects.^{163 199} Therefore, a fixed-combination preparation containing antigens for all 3 diseases (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed; DTaP) is preferred for primary and booster immunization against these diseases in infants and children 6 weeks through 6 years of age.^{100 101 119 199} DT should be used for primary or booster immunization against diphtheria and tetanus only when there is a contraindication to the pertussis antigens contained in DTaP.^{100 101 113 119 199}

Td usually is the preparation of choice for primary and booster immunization against diphtheria and tetanus in individuals ≥7 years of age.^{100 101 133 145 199 200} However, to reduce morbidity associated with pertussis, ACIP recommend that a single dose of a fixed-combination preparation that also contains pertussis antigens (tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed; Tdap) be used in place of a required primary or booster dose of Td in individuals ≥7 years of age who have not previously received Tdap, unless the pertussis antigens are contraindicated or should not be used.^{132 133 135 145 199 200 234 235 236} Individuals in this age group who previously received a single dose of Tdap should then receive Td for all subsequent primary or booster doses.^{132 133 135 145 199 200}

Combined active immunization with a preparation containing tetanus toxoid adsorbed and passive immunization with tetanus immune globulin (TIG) is used to prevent tetanus in individuals with tetanus-prone wounds who are inadequately vaccinated against tetanus or whose tetanus vaccination status is uncertain.^{100 101 110 113 132 133 145 164} (See Postexposure Prophylaxis of Tetanus under Uses.)

DT and Td are not indicated for treatment of diphtheria or treatment of tetanus.^{104 107 114}

Because diphtheria and tetanus infections do not necessarily confer immunity, initiate or complete primary immunization against diphtheria and tetanus at the time of recovery from these infections in any previously unvaccinated or incompletely vaccinated individual.^{100 101 113 119}

Preexposure Vaccination Against Tetanus and Diphtheria in High-risk Groups

Travelers who are unvaccinated or incompletely vaccinated against diphtheria and tetanus should receive the remaining recommended doses prior to travel.¹¹⁵

Tetanus, diphtheria, and pertussis occur worldwide.¹¹⁵ CDC, AAP, and others recommend that travelers be adequately immunized against diphtheria, tetanus, and pertussis before leaving the US.^{101 108 115}

Optimum protection is achieved with a primary series of 3 doses of age-appropriate preparation containing diphtheria, tetanus, and pertussis antigens;¹¹⁵ complete vaccination in children <7 years of age generally requires 5 doses of DTaP.^{115 199}

Adults, adolescents, and children ≥7 years of age who are unvaccinated or incompletely vaccinated should receive a single dose of Tdap (unless pertussis antigens are contraindicated or should not be used) followed by the remaining recommended doses of Td according to the usual age-appropriate catch-up vaccination schedule.¹¹⁵ Adults and adolescents ≥11 years of age who were previously vaccinated but have not received Tdap should receive a single dose of Tdap (instead of Td) for booster immunization.¹¹⁵ When indicated to provide protection against pertussis prior to travel, Tdap may be administered regardless of the interval since the last dose of Td.¹¹⁵

If necessary to complete the vaccination series before departure, adults, adolescents, and children can receive an accelerated immunization schedule using the age-appropriate minimum intervals between doses.^{101 108 115} (See Dosage under Dosage and Administration.)

Any individual wounded while traveling who received their most recent dose of a tetanus toxoid-containing preparation >5 years previously may require a dose of Td (or Tdap if they have not previously received a dose of Tdap) for postexposure prophylaxis of tetanus, depending on the nature of the wound.¹¹⁵ (See Postexposure Prophylaxis of Tetanus under Uses.)

Postexposure Prophylaxis of Tetanus

Postexposure prophylaxis of tetanus in individuals with tetanus-prone wounds who previously received <3 doses of a preparation containing tetanus toxoid adsorbed or whose tetanus vaccination status is unknown or uncertain.^{100 101 110 113 132 133 145 164}

Postexposure prophylaxis of tetanus involves active immunization with a tetanus toxoid-containing preparation with or without passive immunization with a dose of tetanus immune globulin (TIG).^{100 101 110 113 132 133 145 164}

Tetanus-prone wounds include, but are not limited to, wounds contaminated with dirt, feces, soil, or saliva, deep wounds, burns, crush injuries, and wounds containing devitalized or necrotic tissue.^{100 101 115 119} Tetanus also has been associated with apparently clean, superficial wounds, surgical procedures, insect bites, animal bites, dental infections, compound fractures, chronic sores and infections, and IV drug abuse.^{115 119}

In the event of injury and possible exposure to tetanus, the need for active immunization against tetanus with or without passive immunization with TIG depends on the individual’s vaccination status and the likelihood of contamination with tetanus bacilli (e.g., condition of wound, source of contamination).^{100 101 132 133 145}

Table 1 summarizes ACIP guidelines for active and passive immunization against tetanus in routine wound management.

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap). A dose of Tdap is preferred to a dose of Td in adolescents and adults 11 through 64 years of age who have not previously received a dose of Tdap. Use Td in individuals in this age group who previously received a dose of Tdap.

Tetanus and diphtheria toxoids adsorbed for adults use (Td). Td is used in adults, adolescents, and children ≥7 years of age. For children 6 weeks through 6 years of age, DTaP usually is indicated, but DT can be used if pertussis antigens are contraindicated. Monovalent tetanus toxoid adsorbed generally is used only when preparations containing tetanus and diphtheria antigens and preparations containing tetanus, diphtheria, and pertussis antigens are contraindicated or unavailable.

If only 3 doses of tetanus toxoid fluid (no longer commercially available in the US) have been received previously, a fourth dose should be given as a preparation containing tetanus toxoid adsorbed.

Yes, if it has been >10 years since last dose of tetanus toxoid-containing preparation.

Yes, if it has been >5 years since last dose of tetanus toxoid-containing preparation; more frequent booster doses not needed and can accentuate adverse effects.

Adapted from the Recommendations of the Immunization Practices Advisory Committee (ACIP) on prevention of diphtheria, tetanus, and pertussis published in MMWR Recomm Rep. 1991; 40(RR-10):1-28, MMWR Recomm Rep. 2006; 55(RR-3):1-43, and MMWR Recomm Rep. 2006; 55(RR-17):1-37.

Table 1. Summary Guide to Tetanus Prophylaxis in Routine Wound Management100132133

Previous Doses of Tetanus Toxoid Adsorbed Received	Clean, Minor Wounds	All Other Wounds
	Tdap or Td	TIG	Tdap or Td	TIG
Unknown or <3	Yes	No	Yes	Yes
≥3	No	No	No	No

Any individual whose tetanus vaccination status is unknown or uncertain should be considered to have had no previous doses of tetanus toxoid adsorbed.^{100 132 133 145}

ACIP, AAP, and AAFP recommend that a single dose of Tdap be used in place of a dose of Td for postexposure prophylaxis in individuals 11 through 64 years of age who have not previously received a dose of Tdap and received their last dose of Td ≥5 years earlier.^{132 133 135 145 199} Any individual in this age group who previously received a single dose of Tdap should receive Td for postexposure prophylaxis.^{132 133 135 145 199}

Anti-infectives are not indicated for tetanus postexposure prophylaxis since they do not neutralize exotoxin already formed and cannot eradicate C. tetani spores, which may revert to toxin-producing vegetative forms.^{100 119}

Postexposure Prophylaxis of Diphtheria

Postexposure vaccination in household and other close contacts of an individual with culture-confirmed or suspected diphtheria.¹⁰⁰

Regardless of vaccination status, all household and other close contacts of an individual with culture-confirmed or suspected diphtheria should promptly receive anti-infective postexposure prophylaxis (single IM dose of penicillin G benzathine or oral erythromycin given for 7–10 days).^{100 101 119 161} Take samples for cultures prior to giving the anti-infective and continue to observe individual for 7 days for evidence of disease.^{100 119 161}

In addition, those who previously received <3 doses of a diphtheria toxoid-containing preparation or whose vaccination status is unknown should receive an immediate dose of an age-appropriate preparation containing diphtheria toxoid adsorbed, and the primary vaccination series should be completed.^{100 101 119} Contacts who previously completed the primary vaccination series should receive an immediate booster dose of an age-appropriate preparation containing diphtheria toxoid adsorbed if it has been ≥5 years since their last booster dose.^{100 101 119}

Diphtheria antitoxin (equine) (available in the US only from the CDC under an investigational new drug [IND] protocol) is no longer routinely recommended for postexposure prophylaxis of diphtheria in contacts,^{100 101 119} but may be recommended in exceptional circumstances for postexposure prophylaxis in individuals with known or suspected exposure to toxigenic Corynebacterium.^{143 161} To obtain diphtheria antitoxin (equine), contact the CDC at 404-639-8257 from 8:00 a.m. to 4:30 p.m. EST Monday–Friday or the CDC Emergency Operations Center at 770-488-7100 after hours, on weekends, and holidays.^{119 143 161}

Diphtheria and Tetanus Toxoids Adsorbed, Tetanus and Diphtheria Toxoids Adsorbed Dosage and Administration

Administration

IM Administration

Administer by deep IM injection.^{113 114 164}

Do not administer IV, sub-Q, or intradermally.^{113 114 164}

To ensure a uniform suspension of antigens, shake vial or syringe well prior to administration.^{113 114 164} After shaking, suspension should be turbid, whitish-gray and free from clumps.^{113 114 164} Discard if toxoid cannot be resuspended.^{113 114 164}

Do not dilute.^{113 114 164} Do not mix with any other vaccine or solution.^{113 114 164}

To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.¹³⁴

Depending on patient age, administer IM into anterolateral muscles of the thigh or deltoid muscle of the arm.^{113 114 134 164} In adults, adolescents, and children ≥3 years of age, use deltoid muscle.¹³⁴ In infants and children 6 weeks to 2 years of age, use anterolateral thigh;¹³⁴ alternatively, deltoid muscle can be used in those 1–2 years of age if muscle mass is adequate.¹³⁴

Avoid administering into the gluteal area or areas where there may be a major nerve trunk.^{113 114 134 164} If gluteal muscle is chosen for infants <12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that clinician identify anatomical landmarks prior to injection.¹³⁴ Do not use the same muscle site more than once during the course of primary immunization.¹¹⁴

Prior to injection, ensure that needle is not in a blood vessel.¹¹⁴ Although some experts recommend that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) be performed to ensure that a blood vessel has not been entered, ACIP states that this procedure is not required because large blood vessels are not present at recommended IM injection sites.¹³⁴

Syncope (vasovagal or vasodepressor reaction) may occur following vaccination (usually in adolescents and young adults).¹³⁴ Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination.¹³⁴ If syncope occurs, observe patient until symptoms resolve.¹³⁴

When passive immunization with TIG is indicated in addition to active immunization with a preparation containing tetanus toxoid adsorbed for postexposure prophylaxis of tetanus, DT or Td may be given simultaneously with TIG using different syringes and different injection sites.^{100 132 133 134 145 164} (See Postexposure Prophylaxis of Tetanus under Uses.)

May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites).^{100 101 134 199} (See Interactions.)

When multiple vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites.¹³⁴ Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.¹³⁴ If multiple vaccines must be given into a single limb, the deltoid muscle may be used in older children and adults, but the anterolateral thigh is preferred in infants and younger children.¹³⁴

Dosage

DT should only be used in infants and children 6 weeks through 6 years of age.¹¹⁴ Use only when DTaP cannot be used (i.e., when pertussis antigens are contraindicated or cannot be used).^{100 101 199}

Td should only be used in adults, adolescents, and children ≥7 years of age.^{100 113 164}

Medically stable preterm and low birthweight infants should be vaccinated at the usual chronologic age using the usual dosage.^{100 114 144}

The complete vaccination series and recommended booster doses must be administered to ensure optimal protection against diphtheria and tetanus.^{113 114} Interruptions resulting in intervals between doses longer than recommended do not interfere with the final immunity achieved; there is no need to give additional doses or start the vaccination series over.^{100 114 119 134}

If an accelerated immunization schedule is necessary in infants and children 6 weeks through 6 years of age (e.g., for catch-up immunization, immunization prior to travel), minimum intervals between first, second, and third doses of DT are 4 weeks; minimum intervals between third, fourth, and fifth doses are 6 months.^{108 199} In adults and children ≥7 years of age, minimum interval between first and second dose of Td is 4 weeks; minimum interval between second and third dose is 6 months.^{108 199 200}

Pediatric Patients

Prevention of Diphtheria and Tetanus

Infants and Children 6 Weeks Through 6 Years of Age (DT)

IM

Primary immunization consists of a series of 4 doses with or without a fifth (booster) dose.^{100 101 114 199} Each dose is 0.5 mL.^{100 114}

ACIP, AAP, and AAFP recommend that the first 3 doses be given 4–8 weeks apart (usually at 2, 4, and 6 months of age) and the fourth dose given approximately 6–12 months after the third dose (usually at 15–18 months of age).^{100 101 199} Fourth dose may be given as early as 12 months of age, provided at least 6 months have elapsed since the third dose;^{101 199} this flexibility allows scheduling the fourth dose to coincide with administration of other required vaccines.¹⁰¹

At 4–6 years of age (usually just prior to entry into kindergarten or elementary school), give a fifth (booster) dose to those who completed the primary immunization series before their fourth birthday.^{100 101 114 199} Fifth dose not necessary if last dose of the primary series was given on or after the fourth birthday.^{100 101 114 199}

If accelerated schedule is needed (e.g., for catch-up or prior to travel), give a dose at the first visit (minimum 6 weeks of age); give second and third doses at 4-week intervals after first dose, and give fourth and fifth dose at 6-month intervals after third dose.^{115 199} Fifth dose not necessary if fourth dose was given at ≥4 years of age.¹⁹⁹

Previously Unvaccinated Children 7 through 10 Years of Age (Td)

IM

Primary immunization consists of a series of 3 doses.^{113 199} Each dose is 0.5 mL.^{113 133 164}

Give second dose 4–8 weeks after first dose and give third dose 6–12 months after second dose.^{113 133 164 199}

Preferred primary immunization schedule for catch-up vaccination in previously unvaccinated children 7 through 10 years of age is a single dose of Tdap (unless pertussis antigens are contraindicated or should not be used) followed by a dose of Td given at least 4 weeks after Tdap and a second Td dose given at least 6 months after first Td dose.^{199 236}

Previously Unvaccinated Adolescents 11 through 18 years (Td)

IM

Primary immunization consists of a series of 3 doses.^{113 133 199} Each dose is 0.5 mL.^{113 133 164}

Give second dose 4–8 weeks after first dose and give third dose 6–12 months after second dose.^{113 133 164 199}

Preferred primary immunization schedule for catch-up vaccination in previously unvaccinated adolescents 11 through 18 years of age is a single dose of Tdap (unless pertussis antigens are contraindicated or should not be used) followed by a dose of Td given at least 4 weeks after Tdap and a second Td dose given 6–12 months after first Td dose; however, the Tdap dose may be substituted for any 1 of the 3 doses of Td.^{101 133 135 199}

Booster Doses in Adolescents 11 through 18 Years of Age (Td)

IM

Usual dose is 0.5 mL.^{100 101 113 133 135 164}

To maintain adequate immunity against diphtheria and tetanus, ACIP, AAP, AAFP, and others recommend that all individuals who received primary immunization with any preparation containing diphtheria and tetanus toxoids (DT, Td, DTaP, DTP) receive a booster dose of a preparation containing diphtheria and tetanus toxoids at 11–12 years of age, provided at least 5 years have elapsed since the last dose.^{100 101 133 135 199} Alternatively, a booster dose can be given at 14–16 years of age, but administration at 11–12 years of age ensures immunity in this age group and encourages a routine preadolescent preventive care visit that facilitates administration of other vaccines recommended at this age (e.g., MMR, hepatitis B vaccine, HPV vaccine, varicella vaccine, meningococcal vaccine).^{133 199}

Adolescents 11 through 18 years of age who have not previously received a dose of Tdap: Unless the pertussis component is contraindicated or should not be used, substitute a singledose of Tdap (0.5 mL) instead of Td for the adolescent booster dose given at 11 through 18 years of age.^{132 135 199} If Tdap is unavailable or was administered previously, use Td.¹³²

Postexposure Prophylaxis of Tetanus

An emergency dose of a preparation containing tetanus toxoid adsorbed may be indicated with or without a dose of TIG.^{100 101 113 119 133 135 164} (See Postexposure Prophylaxis of Tetanus under Uses.)

Wound care is an essential part of postexposure prophylaxis of tetanus and is necessary regardless of vaccination status.^{100 101} Clean and debride wounds properly, especially if dirt or necrotic tissue are present; remove all necrotic tissue and foreign material.¹⁰¹

Children 7 through 10 Years of Age (Td)

IM

Usual dose is 0.5 mL.^{100 101 113 164}

Individuals who previously received <3 doses of a tetanus-toxoid-containing preparation: Give an emergency booster dose of Td as soon as possible if an injury and possible exposure to tetanus occurs.^{100 101 113 119}

Individuals who previously received ≥3 doses of a tetanus toxoid-containing preparation: Give an emergency booster dose of Td if the injury is a clean, minor wound (not tetanus prone) and >10 years have elapsed since primary immunization against tetanus or the last booster dose of a tetanus toxoid-containing preparation.^{100 113 119} If injury is extensive (moderately or very tetanus prone), give an emergency booster dose of Td if >5 years have elapsed since primary immunization against tetanus or the last booster dose.^{100 113 119}

Adolescents 11 through 18 Years of Age (Td)

IM

Usual dose is 0.5 mL.^{100 101 113 164}

Individuals who previously received <3 doses of a tetanus-toxoid-containing preparation: Give an emergency booster dose of age-appropriate preparation containing tetanus toxoid adsorbed as soon as possible if an injury and possible exposure to tetanus occurs.^{100 101 113 119 133}

Individuals who previously received ≥3 doses of a tetanus toxoid-containing preparation: Give an emergency booster dose of an age-appropriate preparation containing tetanus toxoid adsorbed if the injury is a clean, minor wound (not tetanus prone) and >10 years have elapsed since primary immunization against tetanus or the last booster dose of a tetanus toxoid-containing preparation.^{100 113 119 133} If injury is extensive (moderately or very tetanus prone), give an emergency booster dose of Td if >5 years have elapsed since primary immunization against tetanus or the last booster dose.^{100 113 119 133}

Adolescents 11 through 18 years of age who have not previously received a dose of Tdap and received the last dose of a tetanus toxoid-containing preparation ≥5 years earlier: Unless the pertussis component is contraindicated or should not be used, substitute a singledose of Tdap (0.5 mL) instead of Td.^{133 135} If Tdap is not available or was administered previously, use Td.^{133 135}

Postexposure Prophylaxis of Diphtheria

Household and Other Close Contacts of an Individual with Known or Suspected Diphtheria

IM

Individuals who previously received <3 doses of a diphtheria toxoid-containing preparation or whose vaccination status is unknown: Give an immediate dose of an age-appropriate preparation containing diphtheria toxoid and complete the primary vaccination series.^{100 101 119}

Individuals who previously completed the primary vaccination series but have not received a dose within the last 5 years: Give a booster dose of an age-appropriate preparation containing diphtheria toxoid.^{100 101 119}

Used as an adjunct to anti-infective postexposure prophylaxis.^{100 101 119} (See Postexposure Prophylaxis of Diphtheria under Uses.)

Adults

Prevention of Diphtheria and Tetanus

Primary Immunization in Adults ≥19 Years of Age (Td)

IM

Primary immunization in previously unvaccinated individuals or those with an uncertain vaccination history consists of a series of 3 doses.^{100 113 132 164} Each dose is 0.5 mL.^{100 113 132 164 200}

Give second dose 4–8 weeks after first dose and give third dose 6–12 months after second dose.^{100 113 132 164 200}

Adults 19 through 64 years of age who have not previously received a dose of Tdap: Unless the pertussis component is contraindicated or should not be used, substitute a single dose of Tdap (0.5 mL) instead of any 1 of the 3 doses of Td in the primary series.^{132 200} Preferably, give a dose of Tdap as the first dose, then give a dose of Td at least 4 weeks after the Tdap dose and at 6–12 months after the first dose of Td.¹³² If Tdap is not available or was administered previously, use Td.^{132 200}

Booster Doses in Adults ≥19 Years of Age (Td)

IM

Usual dose is 0.5 mL.^{100 132 164}

After primary immunization, give routine booster dose of Td every 10 years.^{100 132 164 200} In addition, in the event of an injury and possible exposure to tetanus, an emergency booster dose of Td may be indicated.^{100 119 132 164} (See Postexposure Prophylaxis of Tetanus under Dosage and Administration.)

Adults 19 through 64 years of age who have not previously received a dose of Tdap: Unless the pertussis component is contraindicated or should not be used, substitute a single dose of Tdap (0.5 mL) instead of Td.^{132 200} Thereafter, give routine booster dose of Td every 10 years.^{132 200}

Postexposure Prophylaxis of Tetanus

An emergency dose of a preparation containing tetanus toxoid adsorbed may be indicated with or without a dose of TIG.^{100 101 113 119 132 133 145 164} (See Postexposure Prophylaxis of Tetanus under Uses.)

Wound care is an essential part of postexposure prophylaxis of tetanus.^{100 101} Wound care is necessary regardless of vaccination status.^{100 101} Clean and debride wounds properly, especially if dirt or necrotic tissue are present; remove all necrotic tissue and foreign material.¹⁰¹

Adults ≥19 Years of Age (Td)

IM

Usual dose is 0.5 mL.^{100 113 164}

Individuals who previously received <3 doses of a tetanus-toxoid-containing preparation: Give an emergency booster dose of Td (0.5 mL) as soon as possible if an injury and possible exposure to tetanus occurs.^{100 113 119}

Individuals who previously received ≥3 doses of a tetanus toxoid-containing preparation: Give an emergency booster dose of Td if the injury is a clean, minor wound (not tetanus prone) and >10 years have elapsed since primary immunization against tetanus or the last booster dose of a tetanus toxoid-containing preparation.^{100 113 119} If injury is extensive (moderately or very tetanus prone), give an emergency booster dose of Td if >5 years have elapsed since primary immunization against tetanus or the last booster dose.^{100 113 119}

Adults 19 through 64 years of age who have not previously received a dose of Tdap: Substitute a single dose of Tdap (0.5 mL) instead a booster dose of Td.^{132 200}

Postexposure Prophylaxis of Diphtheria

Household and Other Close Contacts of an Individual with Known or Suspected Diphtheria

IM

Individuals who previously received <3 doses of a diphtheria toxoid-containing preparation or whose vaccination status is unknown: Give an immediate dose of an age-appropriate preparation containing diphtheria toxoid and complete the primary vaccination series.^{100 101 119}

Individuals who previously completed the primary vaccination series but have not received a dose within the last 5 years: Give a booster dose of an age-appropriate preparation containing diphtheria toxoid.^{100 101 119}

Used as an adjunct to anti-infective postexposure prophylaxis.^{100 119} (See Postexposure Prophylaxis of Diphtheria under Uses.)

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Diphtheria and Tetanus Toxoids Adsorbed, Tetanus and Diphtheria Toxoids Adsorbed

Contraindications

• Anaphylaxis or other serious allergic reaction following a dose of any preparation containing diphtheria or tetanus toxoid.^{113 114 164} (See Hypersensitivity Reactions under Cautions.)

• Hypersensitive to any ingredient in the formulation (e.g., thimerosal).^{113 114 164}

• History of neurologic reaction following a prior dose.¹¹⁴ (See Guillain-Barré Syndrome and Other Neurologic Disorders under Cautions.)

Warnings/Precautions

Warnings

Frequent Booster Doses

Administer booster doses only when indicated.^{100 113 114 164} Booster doses given more frequently than recommended are associated with an increased incidence and severity of adverse effects.^{100 113 114 132 164}

Give a booster dose in adolescents 11–12 years of age if at least 5 years have elapsed since the last dose.^{113 164}

Administer routine booster doses once every 10 years.^{113 114 164} Do not administer emergency booster doses unless at least 5 years have elapsed since the last dose.¹¹³ If a booster dose is given sooner than 10 years after a previous dose, do not give next routine booster dose for 10 years.¹¹³ (See Dosage and Administration.)

Guillain-Barré Syndrome and Other Neurologic Disorders

Neurologic disorders, including cochlear lesions, brachial plexus neuropathies, paralysis of radial or recurrent nerves, accommodation paresis, Guillain-Barré syndrome (GBS), and EEG disturbances with encephalopathy, have been reported as temporally associated with tetanus toxoid.^{114 140}

The Institute of Medicine (IOM) reviewed reports of neurologic events following administration of tetanus toxoid (not commercially available in the US),Td, or DT and concluded that evidence favored acceptance of a causal relationship between tetanus toxoid and brachial neuritis and GBS, but was inadequate to accept or reject a causal relationship between the toxoids and other neurologic effects.^{113 114} Analysis of active surveillance data collected during 1991 failed to demonstrate an increased risk of GBS in children or adults within 6 weeks following vaccination with a preparation containing tetanus toxoid adsorbed.^{132 133 160}

The manufacturer of DT states that the toxoid should not be used in individuals who have had a neurologic reaction to a previous dose.¹¹⁴ The manufacturers of Td state that a decision to administer a vaccine containing tetanus toxoid adsorbed to an individual with a history of GBS within 6 weeks after receiving a prior dose should be based on the potential benefits and possible risks.^{113 164}

ACIP states that a history of GBS occurring within 6 weeks after a previous dose of a preparation containing tetanus toxoid adsorbed should be considered a precaution for subsequent doses of such preparations.^{132 133 134} ACIP does not consider brachial neuritis a precaution or contraindication for further doses.^{132 133 134}

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactic or anaphylactoid reactions, characterized by urticaria and angioedema, difficulty breathing, hypotension, and/or shock, have been reported following administration of preparations containing tetanus and/or diphtheria antigens.^{100 113 114 117 118 164} Deaths have been reported.^{113 114}

Prior to use, review patient’s history regarding possible sensitivity and previous adverse reactions; take all precautions known for preventing allergic or any other adverse effects.^{113 114 164}

If further doses are being considered (e.g., for tetanus postexposure prophylaxis), consider consultation with an allergist.¹¹³ Although skin testing has been suggested to help determine whether additional doses of a tetanus toxoid-containing preparation can be used in an individuals who developed a systemic reaction to the toxoid, utility of skin testing has been questioned since mild, nonspecific skin-test reactivity to tetanus toxoid appears to occur commonly, particularly when the preparation is used undiluted.¹⁰⁰

Epinephrine and other appropriate agents and equipment should be available for immediate use in case an anaphylactic reaction occurs.^{113 114 164}

Arthus-type Hypersensitivity Reactions

Arthus-type hypersensitivity reactions to tetanus toxoid reported,^{100 114 132 133 135 164} most frequently in those who have received a large number of booster doses of preparations containing diphtheria and tetanus toxoids.¹¹⁹

Reaction is an extensive local inflammatory reaction (vasculitis) that generally begins 2–12 hours after a dose.^{114 119 132 133 135} There may be severe pain, swelling, induration, edema, hemorrhage, and necrosis.^{119 132 135} In some cases, painful swelling may extend from the shoulder to the elbow.¹¹⁹

Arthus reactions usually resolve without sequelae.^{132 133}

Individuals who have Arthus-type hypersensitivity reactions or a temperature >39.4°C following a dose of a tetanus toxoid-containing preparation usually have high serum tetanus antitoxin levels and generally should not receive doses more frequently than every 10 years, even if postexposure prophylaxis against tetanus is indicated.^{100 113 114 132 133}

Thimerosal Allergy

DT and Td contain trace amounts of thimerosal from the manufacturing process (≤0.3 mcg of mercury per 0.5-mL dose).^{113 114 164} (See Thimerosal Precautions under Cautions.) Hypersensitivity reactions to thimerosal contained in vaccines have been reported in some individuals.^{130 150 152 159} These reactions usually manifest as local, delayed-type hypersensitivity reactions (e.g., erythema, swelling),^{130 134 159} but a generalized reaction manifested as pruritus and an erythematous, maculopapular rash on all 4 extremities has been reported rarely.¹⁵² Even when patch or intradermal tests for thimerosal sensitivity are positive, most individuals do not develop hypersensitivity reactions to thimerosal administered as a component of vaccines.^{134 159}

The manufacturer states that DT is contraindicated in individuals hypersensitive to thimerosal.¹¹⁴ The ACIP states that a history of delayed-type hypersensitivity to thimerosal is not a contraindication to use of vaccines that contain thimerosal.¹³⁴

Latex Sensitivity

Some packaging components of DT (e.g., vial stopper) contain dry natural latex.¹¹⁴

Some individuals may be hypersensitive to natural latex proteins.^{137 138 139} Take appropriate precautions if these preparations are administered to individuals with a history of latex sensitivity.^{137 138 139}

ACIP states that vaccines supplied in vials or syringes containing dry natural rubber or natural rubber latex may be administered to individuals with latex allergies other than anaphylactic allergies (e.g., history of contact allergy to latex gloves), but should not be used in those with a history of severe (anaphylactic) allergy to latex, unless the benefits of vaccination outweigh the risk of a potential allergic reaction.¹³⁴ Contact-type allergy is the most common type of latex sensitivity.¹³⁴

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.^{113 114 164} Consider possibility that the immune response to the vaccine and efficacy may be reduced in these individuals.^{113 114 164} (See Specific Drugs under Interactions.)

Recommendations regarding use of tetanus and diphtheria toxoids in HIV-infected individuals are the same as those for individuals who are not HIV-infected.^{105 120 146} However, immunization may be less effective in individuals with HIV infection than in immunocompetent individuals.^{105 106 113 114 146}

Thimerosal Precautions

Although there is no convincing evidence that the low concentrations of thimerosal (a mercury-containing preservative) contained in some vaccines is harmful to vaccine recipients,^{131 134 147 148 151 153 154 155 156 157 158} efforts to eliminate or reduce the thimerosal content in vaccines is recommended as a prudent measure to reduce mercury exposure in infants and children and part of an overall strategy to reduce mercury exposures from all sources, including food and drugs.^{127 128 129 131 134}

It was suggested that thimerosal in vaccines theoretically could have adverse effects in vaccine recipients; however, there is no conclusive evidence that the low levels of thimerosal contained in vaccines cause harm in vaccine recipients.^{131 134 147 148 151 153 154 155 156 157 158}

DT and Td in single-dose vials and syringes are formulated without preservatives and contain only trace amounts of thimerosal from the manufacturing process (≤0.3 mcg of mercury per 0.5-mL dose).^{113 114 164} FDA states that trace amounts of thimerosal from the manufacturing process are not considered clinically important.¹³⁰

Poliomyelitis

Manufacturer states that routine use of DT should be deferred during an outbreak of poliomyelitis.¹¹⁴

Concomitant Illnesses

A decision to administer or delay vaccination in an individual with a current or recent febrile illness depends on the severity of symptoms and etiology of the illness.^{100 113 114 134}

Minor acute illness, such as mild diarrhea or mild upper respiratory tract infection (with or without fever) generally does not preclude vaccination, but defer vaccination in individuals with moderate or severe acute illness (with or without fever).^{100 113 114 134}

Individuals with Bleeding Disorders

Because bleeding may occur following IM administration in individuals with thrombocytopenia or a bleeding disorder (e.g., hemophilia) or in those receiving anticoagulant therapy, use in such individuals only if benefits outweigh risks.¹¹⁴

ACIP states that IM vaccines can be used in individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient’s bleeding risk determines that the injection can be administered with reasonable safety.¹³⁴ In these cases, use a fine needle (23 gauge) to administer the dose and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.¹³⁴ If patient is receiving antihemophilia therapy, administer the IM vaccine shortly after a scheduled dose of such therapy.¹³⁴

Advise the individual and/or their family about the risk of hematoma from IM injections.¹³⁴

Limitations of Vaccine Effectiveness

May not protect all individuals from diphtheria and tetanus.^{113 114}

Optimum protection against diphtheria and tetanus is achieved with a primary series of 3 doses of preparations containing diphtheria and tetanus toxoids adsorbed.¹¹⁵

Duration of Immunity

Following primary immunization, duration of protection against tetanus usually lasts ≥10 years, and some individuals may be protected for life.^{101 119} However, antitoxin levels decrease over time, and most individuals have levels that are suboptimal 10 years after the last dose.¹¹⁹ The antitoxin response induced by tetanus toxoid adsorbed has a longer duration than that induced by tetanus toxoid (not commercially available in the US).¹¹⁹

Following primary immunization, protective levels of diphtheria antitoxin levels may persist for ≥10 years.¹¹⁹ However, levels decrease over time and are below optimal levels in many individuals 10 years after the last dose.¹¹⁹

Pre- and Postvaccination Serologic Testing

To avoid unnecessary vaccination, ACIP states that prevaccination serologic testing for tetanus and diphtheria antitoxin antibodies can be considered in children ≥7 years of age, adolescents, or adults who probably were vaccinated but cannot produce vaccination records.^{132 133} If levels of tetanus and diphtheria antitoxin are both ≥0.1 international units/mL, previous vaccination with diphtheria and tetanus toxoids adsorbed can be assumed.^{132 133}

When postexposure prophylaxis against tetanus is indicated or when preexposure vaccination in high-risk groups (e.g., travelers) is indicated, individuals with an unknown or uncertain history of vaccination generally should be considered unvaccinated and should receive the full 3-dose primary immunization series.^{100 115 132} Routine prevaccination serologic testing is not recommended in these individuals.^{132 133}

Improper Storage and Handling.

Improper storage or handling of vaccines may reduce vaccine potency and can result in reduced or inadequate immune responses in vaccinees.¹⁴¹

Do not administer DT or Td that has been mishandled or has not been stored at the recommended temperature.¹⁴¹ (See Storage under Stability.)

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.¹⁴¹ If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.¹⁴¹

Specific Populations

Pregnancy

Category C.^{113 164}

Because of the risks associated with tetanus and diphtheria infection, ACIP, AAP, and AAFP state that pregnancy is not considered a contraindication for preparations containing diphtheria and tetanus antigens.^{100 101 132 133 135 145}

Ideally, primary immunization against tetanus and diphtheria should be completed prior to pregnancy.^{100 101 115 132 145} Although there is no evidence that the toxoids are teratogenic, waiting until the second or third trimester of pregnancy (before 36 weeks of gestation) to administer diphtheria and tetanus toxoids is recommended.^{100 101 135 145}

Pregnant women who have not received primary immunization with DTaP, DTP (not commercially available in the US), DT, Td, or single-antigen tetanus toxoid adsorbed (including those with unknown or incomplete tetanus immunization) should receive a primary series of 3 doses of vaccine containing diphtheria and tetanus antigens beginning during pregnancy.^{145 234} In most situations, Td is the preferred preparation for primary or booster immunization against diphtheria and tetanus during pregnancy.^{101 133 145} However, in previously unvaccinated or incompletely vaccinated pregnant women who have not received a dose of Tdap, substitute Tdap for one of the required Td doses, preferably in the third or late second trimester (i.e., after 20 weeks gestation).²³⁴

Pregnant women who were previously vaccinated but received the most recent dose of a preparation containing tetanus and diphtheria antigens ≥10 years ago should receive a booster dose of Td during the second or third trimester of pregnancy (and before 36 weeks of gestation).^{100 101 132 145} This dose is important if the woman does not have sufficient tetanus immunity to protect against maternal and neonatal tetanus or if protection against diphtheria is needed (e.g., for travel to an area where diphtheria is endemic).¹⁴⁵ However, if the woman has not previously received a dose of Tdap, Tdap should be used for the booster dose instead of Td and preferably should be given during the third or late second trimester (i.e., after 20 weeks gestation).²³⁴

When a pregnant woman’s history of tetanus vaccination is uncertain, serologic testing can be done to determine whether she has protective levels of tetanus antitoxin (i.e., ≥0.1 international units when tested using enzyme-linked immunosorbent assay [ELISA]).¹⁴⁵ Those who have never been vaccinated against tetanus or who have levels of tetanus antitoxin that are not protective should receive at least 2 doses of a preparation containing tetanus toxoid adsorbed given at least 4–6 weeks before delivery to stimulate antitoxin levels that are sufficient to protect the mother and cross the placenta to protect the neonate.^{133 145} Because diphtheria is rare in the US, serologic testing for diphtheria antitoxin is not usually necessary in pregnant women.¹⁴⁵

If postexposure prophylaxis of tetanus is indicated as part of wound management in a pregnant women and it has been ≥5 years since she received a preparation containing tetanus antigen, a booster dose of Td should be administered.²³⁴ However, if the woman has not previously received a dose of Tdap, Tdap should be used for the booster dose instead of Td.²³⁴

Lactation

Not known whether diphtheria or tetanus toxoids absorbed are distributed into milk.^{113 164} Manufacturers recommend caution in nursing women.^{113 164} ACIP states breastfeeding is not considered a contraindication for diphtheria and tetanus toxoids adsorbed.¹⁴⁵

Pediatric Use

DT: Safety and efficacy not established in children <6 weeks of age or in children ≥7 years of age.¹¹⁴

Td: Safety and efficacy not established in children <7 years of age.^{113 164}

DT contains a higher dose of diphtheria toxoid (6.7 Lf units) than Td (2 Lf units).^{113 114 164} Because individuals ≥7 years of age have an increased incidence of adverse reactions to preparations containing >2 Lf units of diphtheria toxoid, DT should not be used in individuals ≥7 years of age.^{113 114}

Geriatric Use

DT: Not indicated in adults, including geriatric adults.¹¹⁴

Td: Clinical studies did not include sufficient numbers of individuals ≥65 years of age to determine whether these individuals respond differently than younger individuals.^{113 164}

Common Adverse Effects

Mild to moderate local reactions at injection site, including erythema,^{100 113 114 164} warmth,^{114 164} edema,^{114 164} tenderness,^{113 164} induration,^{100 113 114 164} urticaria,^{114 164} and rash;^{114 164} a nodule may be palpable at the injection site.^{100 113} Mild systemic reactions, including fatigue or malaise,^{113 114 132 164} fever,^{100 113 114 164} chills,¹³² headache,^{113 132 164} drowsiness,¹⁰⁰ fretfulness,¹⁰⁰ hypotension,¹¹⁴ nausea,^{114 132 164} diarrhea,¹³² vomiting,¹³² anorexia,¹⁰⁰ generalized body ache,¹³² myalgia,¹⁶⁴ arthralgia.^{100 132 164}

Interactions for Diphtheria and Tetanus Toxoids Adsorbed, Tetanus and Diphtheria Toxoids Adsorbed

Other Vaccines

Although specific data not available regarding concurrent administration of DT or Td with all other available vaccines,^{113 114} primary immunization against diphtheria and tetanus can be integrated with primary immunization against pertussis, Haemophilus influenzae type b (Hib), hepatitis A, hepatitis B, influenza, measles, mumps, rubella, meningococcal disease, pneumococcal disease, poliomyelitis, rotavirus, and varicella.^{100 101 113 114 199} However, each parenteral vaccine should be administered using a different syringe and different injection site.^{100 101 113 114 199}

DT or Td may be administered simultaneously with or at any interval before or after live viral vaccines, including measles, mumps, and rubella vaccine (MMR).^{101 114 134} In addition, DT or Td may be administered simultaneously with or at any interval before or after inactivated vaccines, including Hib vaccine, hepatitis B vaccine (HepB), and poliovirus vaccine inactivated (IPV).¹³⁴

Specific Drugs

Drug	Interaction	Comments
Diphtheria antitoxin (equine) (available in the US only from the CDC under an investigational new drug [IND] protocol)	Although specific studies are not available, diphtheria antitoxin (equine) is unlikely to impair the immune response to diphtheria toxoid adsorbed100	May be administered simultaneously using different syringes and different injection sites114
Hib vaccine		May be administered simultaneously (using different syringes and injection sites) or at any time before or after Hib vaccine114
Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific hyperimmune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])		May be administered simultaneously (using different syringes and injection sites) or at any time before or after immune globulin or specific hyperimmune globulin134 For postexposure prophylaxis in wound management, active immunization against tetanus (if indicated) with DT or Td should be initiated at the same time as passive immunization with TIG; however, TIG and the toxoid should be given at separate sites using different syringes100 113 114 132 133 164
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)	Individuals receiving immunosuppressive agents may have a diminished immunologic response to diphtheria and tetanus toxoids adsorbed113 114 164 There is some evidence that children receiving immunosuppressive therapy, including those with malignancies receiving maintenance chemotherapy, may have adequate antibody responses to diphtheria and tetanus toxoids adsorbed101 103 Short-term (<2 weeks), low- to moderate-dose systemic corticosteroid therapy; long-term, alternate-day, systemic corticosteroid therapy using low to moderate doses of short-acting drugs; topical corticosteroid therapy (e.g., nasal, cutaneous, ophthalmic); or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive in usual dosages100 134	If primary immunization is started in individuals receiving an immunosuppressive agent, serologic testing may be needed to ensure adequate antibody response and additional doses of the toxoids may be necessary; if possible, the immunosuppressive agent should be temporarily discontinued if an emergency booster dose of toxoid is required114
Measles, mumps, and rubella vaccine (MMR)	DT and MMR have been administered simultaneously without a decrease in immune response or increase in adverse effects114	May be administered simultaneously (using different syringes and different injection sites) or at any interval before or after MMR101 114 134
Meningococcal vaccine	MCV4 (Menactra): Td has been administered concomitantly with Menactra without reduced antibody response or increased adverse effects;135 142 although clinical importance unclear, antibody responses to diphtheria and certain meningococcal antigens were higher when Menactra was administered concomitantly with Td compared with administration 28 days after Td135 142	Td may be administered simultaneously (using different syringes and different injection sites) or at any interval before or after Menactra133
Poliovirus vaccine	DT and poliovirus vaccine live oral (OPV; not commercially available in the US) have been administered simultaneously without a decrease in immune response or increase in adverse effects114	May be administered simultaneously with poliovirus vaccine inactivated (IPV) using different syringes and different injection sites114

Stability

Storage

Parenteral

Injectable Suspension, for IM use

2–8°C; do not freeze.^{113 114 164}

Actions

• Diphtheria and tetanus toxoids adsorbed f(DT) and tetanus and diphtheria toxoids adsorbed (Td) are sterile suspensions prepared by mixing suitable quantities of diphtheria and tetanus toxoids that have been formaldehyde-treated, purified, and adsorbed onto an aluminum adjuvant.^{113 114 164}

• Antigen content of the toxoids is expressed in terms of flocculation units (Lf).^{113 114 164} Each 0.5 mL of DT contains 6.7 Lf units of diphtheria toxoid absorbed and 5 Lf units of tetanus toxoid.¹¹⁴ Each 0.5 mL of Td contains 2 Lf units of diphtheria toxoid absorbed and, depending on the manufacturer, 2 or 5 Lf units of tetanus toxoid absorbed.^{113 164}

• DT and Td stimulate active immunity to diphtheria and tetanus by inducing production of specific neutralizing antitoxin antibodies.^{101 113 114 164}

• A complete primary immunization series with the age-appropriate preparation is needed to induce optimum levels of antitoxin that provide protection.^{100 114 119}

• The diphtheria toxoid component provides protection only against the exotoxin elucidated by C. diphtheriae.^{113 114} Immunization does not prevent or eliminate colonization or carriage of C. diphtheriae in pharynx, nose, or skin.^{100 113 115}

• Protective levels of diphtheria antitoxin (defined as ≥0.1 international units/mL)^{113 119 132 133} are attained in >95% of individuals after the primary vaccination series.¹¹⁹ Antitoxin levels may persist for ≥10 years.¹¹³ However, levels decrease over time and are below optimal levels in many individuals 10 years after the last dose.¹¹⁹

• Protective levels of tetanus antitoxin (defined as ≥0.1 international units/mL using enzyme-linked immunoabsorbant assay [ELISA])^{132 133} are attained in almost 100% of individuals after the primary vaccination series.¹¹⁹ Antitoxin levels may persist for ≥10 years^{100 113 114} and some individuals may be protected for life.¹¹⁹ However, levels decrease over time and most individuals have levels that are suboptimal 10 years after the last dose.¹¹⁹

Advice to Patients

• Prior to administration of each vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative as required by the National Childhood Vaccine Injury Act (VISs are available at ).^{113 114 136 164}

• Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination with tetanus and diphtheria toxoids.^{113 114 164}

• Importance of receiving the complete primary immunization series and recommended booster doses to ensure highest level of protection against tetanus and diphtheria.^{100 113 114 164}

• Advise patient that the toxoids may not provide protection in all vaccinees.^{113 114}

• Advise patient they should not receive tetanus and diphtheria toxoids if they have had a life-threatening allergic reaction to a previous dose.^{113 114}

• Importance of contacting clinicians if a hypersensitivity reaction occurs following a dose.¹³⁶ Clinicians or individuals can report any adverse reactions that occur following vaccination to Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .^{113 114 136 164}

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{113 114 164}

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{113 114 164}

• Importance of informing patients of other important precautionary information.^{113 114 164} (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Diphtheria and Tetanus Toxoids Adsorbed

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use	Diphtheria Toxoid 6.7 Lf units and Tetanus Toxoid 5 Lf units per 0.5 mL	Diphtheria and Tetanus Toxoids Adsorbed	Sanofi Pasteur

Tetanus and Diphtheria Toxoids Adsorbed

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use	Tetanus Toxoid 2 Lf units and Diphtheria Toxoid 2 Lf units per 0.5 mL	Tetanus and Diphtheria Toxoids Adsorbed	MassBiologics, Merck
		Tetanus Toxoid 5 Lf units and Diphtheria Toxoid 2 Lf units per 0.5 mL	Decavac	Sanofi Pasteur