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Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Class: Toxoids
ATC Class: J07AM01
VA Class: IM105
Brands: Adacel, Boostrix, Daptacel, Infanrix, Kinrix, Pediarix, Pentacel, TriHIBit, Tripedia

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Introduction

Fixed-combination preparations containing formaldehyde-treated tetanus and diphtheria toxins (toxoids) and acellular pertussis vaccine adsorbed onto aluminum adjuvants.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ Used to stimulate active immunity to diphtheria, tetanus, and pertussis.¹¹¹ ¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ¹⁹⁵ ¹⁹⁶ ²⁰⁵ Commercially available as diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP; Daptacel, Infanrix, Tripedia)¹⁵² ¹⁸² ¹⁸⁷ and tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap; Adacel, Boostrix).¹⁹² ¹⁹³ Antigen potency varies depending on the manufacturer.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ DTaP also commercially available in a fixed-combination vaccine that contains diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix),²²³ in a fixed-combination vaccine that contains diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix),¹⁰⁹ in a combination vaccine that contains diphtheria, tetanus, pertussis, and Haemophilus influenza type b (Hib) antigens (DTaP/Hib; TriHIBit),¹⁵² ¹⁶⁴ and in a combination vaccine that contains diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel).²²⁴ Although no longer available in the US, diphtheria and tetanus toxoids and whole-cell pertussis vaccine adsorbed (DTP, also referred to as DTwP) may still be used in other countries.¹⁰⁰ ¹⁹⁸

Uses for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Prevention of Diphtheria, Tetanus, and Pertussis

Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) and tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) are used to stimulate active immunity to diphtheria, tetanus, and pertussis.¹⁰⁰ ¹⁴⁸ ¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³

Diphtheria is caused by toxigenic strains of Corynebacterium diphtheriae or, rarely, toxigenic strains of C. ulcerans.¹⁰⁰ ¹¹¹ ¹¹⁵ ¹⁹⁵ ¹⁹⁶ ¹⁹⁸ ²⁰⁵ ²²⁸ 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.¹⁹⁸ 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.¹⁰⁰ ¹¹¹ ¹⁹⁸ ²²⁸ Diphtheria continues to circulate worldwide and is endemic in many countries in Africa, Latin America, Asia/South Pacific, Middle East, and Russia and surrounding countries.¹⁰⁰ ¹¹¹ ¹¹⁵ ¹⁹⁸ 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.¹⁹⁸ Most cases of diphtheria occur in individuals who are unvaccinated or incompletely vaccinated against the disease.¹⁰⁰ ¹¹¹ ¹¹⁵ ¹⁹⁸

Tetanus is a potentially fatal disease caused by a neurotoxic exotoxin (tetanospasmin) produced by Clostridium tetani.¹⁰⁰ ¹¹⁵ ¹⁹⁸ C. tetani spores are ubiquitous in the environment worldwide and found in soil and in animal (e.g., horses, sheep, cattle, dogs, cats, rats, guinea pigs, chickens) and human intestinal tracts.¹⁰⁰ ¹¹¹ ¹¹⁵ ¹⁹⁵ ¹⁹⁸ 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.¹⁰⁰ ¹⁹⁵ ¹⁹⁸ 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.¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁸ ²⁰⁵ Obstetric tetanus occurs within 6 weeks after delivery or termination of pregnancy because of contaminated wounds or abrasions or unclean deliveries or abortions.²⁰⁵ Generalized tetanus is characterized by rigidity and convulsive muscle spasms that usually involve the jaw (lockjaw) and neck and then become generalized.¹⁰⁰ ¹⁹⁵ ¹⁹⁸ Tetanus occurs worldwide, almost exclusively in individuals who are unvaccinated or inadequately vaccinated against the disease.¹⁰⁰ ¹¹⁵ An average of 31 cases reported each year in the US from 2000 through 2007 (case fatality rate 10%);¹⁹⁸ a low of 20 cases reported in 2003.¹⁹⁸ Most cases of tetanus in the US occur following acute injuries or wounds (puncture wounds, lacerations, abrasions)¹⁹⁹ ¹⁹⁸ 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).¹¹² ¹⁹⁸

Pertussis (whooping cough) is an acute respiratory tract infection caused by Bordetella pertussis.¹⁰⁰ ¹¹⁵ ¹⁹⁷ ¹⁹⁸ ²⁰¹ ²⁰⁵ During 2000–2006, there were 103,940 cases of pertussis reported in the US (average 14,849 cases each year) and 156 pertussis-related deaths.²⁰⁵ However, it has been suggested that pertussis infection and reinfection are underrecognized among adults and adolescents and that the pertussis burden may be substantially greater; approximately 600,000 cases are estimated to occur annually among adults.²⁰⁵ The risk for severe pertussis and death is highest among infants <12 months of age (especially during the first few months of life until they have received 1 or 2 doses of DTaP);¹⁰⁰ ²⁰⁵ 93% of pertussis-related deaths occur in this age group, usually in unvaccinated infants.²⁰⁵ B. pertussis infections in adults and adolescents may be asymptomatic or range from mild to severe.²⁰⁵ Outbreaks involving adolescents have occurred in various settings (e.g., middle and high schools, residence facilities for disabled individuals, entire communities).²⁰¹ Data from 2000-2006 indicate that 27% of reported pertussis cases occurred in individuals 15–39 years of age and household contact with these individuals appears to be the source of infection for most cases occurring in young infants.²⁰⁵

The appropriate vaccine containing diphtheria, tetanus, and pertussis antigens is selected based on age and whether primary or booster immunization is indicated.¹⁰⁰ ¹⁴⁸ ¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²⁰⁵

DTaP (Daptacel, Infanrix, Tripedia) is used for primary and booster immunization in infants and children 6 weeks through 6 years of age.¹⁰⁰ ¹⁴⁸ ¹⁴⁹ ¹⁵² ¹⁸² ¹⁸⁷

Tdap is used for booster immunization in adults and adolescents 10 years of age or older (Boostrix) or in adults and adolescents 11 through 64 years of age (Adacel).¹⁹² ¹⁹³ ¹⁹⁵ ¹⁹⁶ In addition, although safety and efficacy of Tdap have not been established for primary immunization,¹⁹² ¹⁹³ USPHS Advisory Committee on Immunization Practices (ACIP) states that a single dose of Tdap (Adacel, Boostrix) should be included in the immunization series when adults, adolescents, or children as young as 7 years of age† require primary immunization† against diphtheria and tetanus, unless the pertussis antigens are contraindicated or should not be used.¹⁹⁵ ¹⁹⁶ ²³⁶ The goal of this strategy is to reduce morbidity associated with pertussis.¹⁹⁵ ¹⁹⁶ ²³⁶ Individuals who previously received a single dose of Tdap should then receive Td for all subsequent primary or booster doses.¹⁹⁶ ²³⁶

ACIP, AAP, and American Academy of Family Physicians (AAFP) recommend that all individuals be immunized against diphtheria, tetanus, and pertussis.¹⁰⁰ ¹⁸⁴ ¹⁹⁹ Use of a combination vaccine generally is preferred over separate injections of equivalent component vaccines;¹⁹⁹ ²²⁷ 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.¹⁹⁹ ²²⁷ Therefore, a fixed-combination preparation containing antigens for all 3 diseases is preferred for primary and booster immunization in children 6 weeks through 6 years of age unless a component is contraindicated or should not be used.¹⁰⁰ ¹³⁴ ¹⁸⁴ ¹⁹⁹ Diphtheria and tetanus toxoids adsorbed (DT) should be used for primary or booster immunization in this age group only when there is a contraindication to the pertussis antigens contained in DTaP.¹⁰⁰ ¹³⁴ ¹⁸⁴ ¹⁹⁹

Tetanus and diphtheria toxoids adsorbed (Td) usually is the preparation of choice for primary and booster immunization against diphtheria and tetanus in individuals ≥7 years of age.¹⁰⁰ ¹⁹⁹ ²⁰⁰ However, to reduce morbidity associated with pertussis, ACIP recommends that a single dose of Tdap (Adacel, Boostrix) be used in place of a required primary or booster dose of Td in adolescents and adults who have not previously received Tdap, unless the pertussis antigens are contraindicated or should not be used.¹⁹⁶ ¹⁹⁹ ²⁰⁰ ²³⁴ ²³⁵ ²³⁶

ACIP recommends that all health-care personnel (regardless of age) receive a single dose of Tdap as soon as feasible if they have not previously received a dose.²³⁵

To provide protection against pertussis and reduce the likelihood of pertussis transmission to infants, ACIP recommends that adolescents and adults who have or anticipate having close contact with an infant <12 months of age (e.g., parents, siblings, grandparents, childcare providers, health-care personnel) receive a single dose of Tdap if they have not previously received a dose.²³⁴ ²³⁶ Administer at least 2 weeks before close contact with infant²³⁴ and give regardless of interval since last dose of vaccine containing diphtheria or tetanus antigens (e.g., Td).²³⁶ If Tdap was not administered prior to pregnancy, pregnant women should preferably receive a Tdap dose during the third or late second trimester (i.e., after 20 weeks gestation).²³⁴ (See Pregnancy under Cautions.)

For internationally adopted children and other immigrants whose immune status is uncertain, vaccinations can be repeated or serologic tests performed to confirm immunity.¹³⁴ For DTaP, although the simplest approach is to revaccinate according to the US recommended immunization schedule, increased rates of local reactions occur after fourth or fifth DTaP dose.¹³⁴ If a severe local reaction occurs, perform serologic testing for specific IgG antibody to tetanus and diphtheria toxoids to determine whether additional doses are necessary.¹³⁴ If child’s records indicate they received ≥3 doses of DTaP (or DTP; no longer commercially available in the US), perform serologic tests; if protective antitoxin antibody levels are present, recorded doses are considered valid and vaccination series should be completed as age-appropriate.¹³⁴ Alternatively, give a single booster dose of DTaP followed by serologic testing 1 month later; if protective levels are present, the recorded doses are considered valid.¹³⁴ If antibody concentrations are indeterminate after booster dose, give the complete age-appropriate vaccination series.¹³⁴

DTaP or Tdap may be indicated in conjunction with passive immunization with tetanus immune globulin (TIG) for postexposure prophylaxis in individuals with tetanus-prone wounds who are inadequately immunized against tetanus or whose tetanus immunization history is uncertain.¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁶ ¹⁹⁸ ²⁰¹ (See Postexposure Prophylaxis of Tetanus under Uses.)

DTaP and Tdap are not indicated for treatment of diphtheria, tetanus, or pertussis.¹⁰⁰ ¹⁹² ¹⁹⁸ ²⁰¹

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.¹⁰⁰ ¹⁹⁸ ²⁰¹ In addition, although well documented pertussis is likely to confer short-term immunity against the disease, protection wanes over time (waning may begin as early as 5–7 years after infection) and initiation or completion of active immunization is indicated at the time of recovery.¹⁰⁰ ¹⁹⁵ ¹⁹⁶ ²⁰¹ ²⁰⁵

When there are no contraindications to any of the individual components, the commercially available fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix) can be used in children 4 through 6 years of age to provide the fifth dose of the DTaP vaccination series and the fourth dose of the IPV vaccination series in those receiving primary immunization with Infanrix (DTaP) and/or Pediarix (DTaP-HepB-IPV).²²³

When there are no contraindications to any of the individual components, the commercially available fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B virus (HBV), and poliovirus antigens (DTaP-HepB-IPV; Pediarix) can be used as a 3-dose series in children 6 weeks through 6 years of age born to HBsAg-negative women.¹⁰⁹ ²⁰⁸ ACIP states this fixed-combination vaccine also may be used to complete the HBV vaccine series in infants 6 months through 6 years of age born to HBsAg-positive women†.²⁰⁸ Pediarix should not be used for the initial dose of hepatitis B vaccine that is indicated in neonates.¹⁰⁰ For prevention of diphtheria, tetanus, and pertussis in infants and children 6 weeks through 6 years of age, Pediarix may be used for the initial 3 doses in the DTaP series.¹⁰⁰ ¹⁰⁹ Pediarix also may be used to complete the first 3 doses of the DTaP series in children who have received 1 or 2 doses of Infanrix DTaP;¹⁰⁹ data not available regarding the safety and efficacy of Pediarix used following ≥1 dose of a DTaP vaccine from a different manufacturer.¹⁰⁹ Children who have received a 3-dose series of Pediarix should complete the DTaP and IPV series according to the recommended childhood immunization schedule.¹⁰⁰ ¹⁰⁹ To complete the DTaP series, the manufacturer recommends that Infanrix be used for the fourth dose of DTaP and either Infanrix DTaP or DTaP-IPV (Kinrix) be used as the fifth dose of DTaP since these vaccines contain the same pertussis antigens as Pediarix.¹⁰⁹

The commercially available combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel) can be used as a 4-dose series for immunization in infants and children 6 weeks through 4 years of age when doses of DTaP, IPV, and Hib vaccine are indicated and there are no contraindications to any of the individual components.¹⁰⁰ ²²⁴ For prevention of diphtheria, tetanus, and pertussis, children who receive the 4-dose series of Pentacel at 2, 4, 6, and 15 through 18 months of age should receive a dose of Daptacel at 4 through 6 years of age to provide the fifth dose of DTaP.²²⁴ Pentacel also may be used in infants and children 6 weeks through 4 years of age who have received 1 or more doses of Daptacel DTaP.²²⁴ However, data are not available on safety and immunogenicity of mixed sequences of Pentacel and Daptacel for successive doses in the DTaP series or mixed sequences of Pentacel and DTaP from other manufacturers.²²⁴

When a fourth dose of DTaP and a fourth dose of Hib vaccine are indicated in a child 15 through 18 months of age, a kit (DTaP/Hib; TriHIBit) containing both DTaP (Tripedia) and Hib polysaccharide conjugate (tetanus toxoid conjugate) vaccine (ActHIB) may be used.¹⁷⁴ ActHIB in the kit is reconstituted with Tripedia.¹⁶⁴ (See Dosage and Administration.) Extemporaneous vaccine combinations should not be prepared using other commercially available DTaP and Hib vaccines.¹⁰⁰ ¹¹⁰ ¹⁴⁸ ¹⁴⁹

Preexposure Vaccination Against Tetanus, Diphtheria, and Pertussis in High-risk Groups

Travelers who are unvaccinated or incompletely vaccinated against diphtheria, tetanus, and pertussis 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.¹⁰⁰ ¹¹⁵ ¹²¹

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 recommended doses of Td according to the usual age-appropriate catch-up vaccination schedule.¹¹⁵ ²³⁶ 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 a dose of Td) when booster immunization is indicated.¹¹⁵ ²³⁶ 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.¹⁰⁰ ¹¹⁵ ¹²¹ (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 uncertain.¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁶ ¹⁹⁸ ²⁰¹

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).¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁶ ¹⁹⁸ ²⁰¹

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.¹⁰⁰ ¹¹¹ ¹¹⁵ ¹⁹⁸ 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.¹¹⁵ ¹⁹⁸

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).¹⁰⁰ ¹¹¹

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

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.

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 Management111195196
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.¹¹¹ ¹⁹⁵ ¹⁹⁶

ACIP, AAP, and AAFP recommend that a single dose of Tdap (Adacel, Boostrix) 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.¹⁹⁵ ¹⁹⁶ ¹⁹⁹ ²⁰¹ ²⁰⁵ Any individual in this age group who previously received a single dose of Tdap should receive Td for postexposure prophylaxis.¹⁹⁵ ¹⁹⁶ ¹⁹⁹ ²⁰¹

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.¹⁰⁰ ¹¹¹

Postexposure Prophylaxis of Diphtheria

Postexposure vaccination in household and other close contacts of an individual with culture-confirmed or suspected diphtheria.¹⁰⁰ ¹¹¹ ¹⁹⁸

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).¹⁰⁰ ¹¹¹ ¹⁹⁸ ²²⁸ Take samples for cultures prior to giving the anti-infective and continue to observe individual for 7 days for evidence of disease.¹¹¹ ¹⁹⁸ ²²⁸

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.¹⁰⁰ ¹¹¹ ¹⁹⁸ 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.¹⁰⁰ ¹¹¹ ¹⁹⁸

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,¹⁰⁰ ¹¹¹ ¹⁹⁸ but may be recommended in exceptional circumstances for postexposure prophylaxis in individuals with known or suspected exposure to toxigenic Corynebacterium.²⁰⁴ ²²⁸ 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.¹⁹⁸ ²⁰⁴ ²²⁸

Postexposure Prophylaxis of Pertussis

Postexposure vaccination in household and other close contacts of an individual with pertussis.¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁶ ²⁰¹

Regardless of vaccination status or age, all household and other close contacts of an individual with suspected pertussis should receive prophylaxis with an anti-infective active against B. pertussis (usually azithromycin, clarithromycin, erythromycin; alternatively, co-trimoxazole).¹⁰⁰ ¹¹¹ ¹⁹⁸ ²⁰⁶

In addition, all close contacts <7 years of age who have not completed primary immunization with DTaP should complete the vaccination series with minimal intervals between doses.¹⁰⁰ ¹¹¹ ¹⁹⁸ Those who received their third dose of DTaP ≥6 months before the exposure should receive a fourth dose.¹⁰⁰

Safety and efficacy of Tdap administered following pertussis exposure in individuals 10 through 64 years of age have not been evaluated, but a booster dose of Tdap is not contraindicated in those who have not previously received a dose.¹⁹⁸ ACIP and AAP state that individuals 11 through 18 years of age at increased risk of pertussis during pertussis outbreaks or because they are close contacts of an individual with pertussis (e.g., in a family, residential facility, school, school-related activity) can receive a dose of Tdap if they have not previously received a dose.¹⁰⁰ ¹⁹⁵ ¹⁹⁶ ²⁰¹

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Dosage and Administration

Administration

DTaP and Tdap

Administer by deep IM injection.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³

Do not administer IV, intradermally, or sub-Q.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³

To ensure a uniform suspension of antigens, shake vigorously prior to withdrawing a dose.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ DTaP and Tdap occur as turbid, white suspensions after shaking.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ Discard if vaccine cannot be resuspended.¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³

Do not mix with any other vaccine or solution.¹⁸² ¹⁸⁷ ¹⁹³

Depending on patient age, administer IM into the anterolateral muscles of the thigh or deltoid muscle of the arm.¹³⁴ ¹⁵² ¹⁸² ¹⁸⁷ In adults, adolescents, and children ≥3 years of age, use deltoid muscle.¹³⁴ ¹⁹² ¹⁹³ In infants and children 6 weeks to 2 years of age, use anterolateral thigh;¹³⁴ ¹⁸⁷ alternatively, deltoid muscle can be used in those 1–2 years of age if muscle mass is adequate.¹³⁴

Avoid administering into gluteal area or areas where there may be a major nerve trunk.¹³⁴ ¹⁵² ¹⁸² ¹⁹² 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

Although some experts state that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) can be performed to ensure that a blood vessel has not been entered, ACIP states 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).¹³⁴ ²⁰⁵ Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination.¹³⁴ ²⁰⁵ If syncope occurs, observe patient until symptoms resolve.¹³⁴ ²⁰⁵

DTaP or Tdap may be given simultaneously with TIG (using different syringes and different injection sites) for postexposure prophylaxis of tetanus when passive immunization is considered necessary in addition to active immunization with a vaccine containing tetanus toxoid adsorbed.¹⁰⁰ ¹¹¹ ¹³⁴ ¹⁵² ¹⁸² ¹⁹² ¹⁹³ ¹⁹⁵ ¹⁹⁶ (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).¹⁰⁰ ¹¹¹ ¹³⁴ ¹⁹⁵ ¹⁹⁶ ¹⁹⁹ ²⁰¹ (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

Combination Vaccines Containing DTaP and Other Antigens

Administer DTaP-IPV (Kinrix), DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel), and DTaP/Hib (TriHIBit) by IM injection.¹⁰⁹ ¹⁶⁴ ²²³ ²²⁴

Do not administer these combination vaccines sub-Q, IV, or intradermally.¹⁰⁹ ¹⁶⁴ ²²³ ²²⁴

Shake vaccine well immediately prior to administration to provide a uniform, turbid, white suspension.¹⁰⁹ ¹⁶⁴ ²²³ ²²⁴ Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.¹⁰⁹ ¹⁶⁴ ²²³ ²²⁴

Do not mix Kinrix, Pediarix, or any component of Pentacel or TriHIBit with any other vaccine or solution.¹⁰⁹ ¹⁵² ²²³ ²²⁴

Depending on patient age, administer by IM injection into the deltoid muscle or anterolateral thigh.¹⁰⁹ ¹³⁴ ¹⁶⁴ ²²³ ²²⁴ In children ≥3 years of age, IM injections should be made into the deltoid muscle if muscle mass is adequate; alternatively, the anterolateral thigh can be used.¹⁰⁹ ¹³⁴ ²²⁴ In children ≤2 years of age, the preferred site for IM injection is the anterolateral aspect of the thigh.¹⁰⁹ ¹³⁴ ²²⁴

Vaccines generally should not be administered into buttock muscle in children because of the potential for injection-associated injury to sciatic nerve.¹³⁴

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 Consider anatomic variability, especially in the deltoid muscle, and use clinical judgment to avoid inadvertent underpenetration or overpenetration of muscle.¹³⁴

Reconstitution (DTaP-IPV/Hib; Pentacel)

DTaP-IPV/Hib (Pentacel) is commercially available as a kit containing single-dose vials of a fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV vaccine) and single-dose vials of lyophilized Hib vaccine (ActHIB).²²⁴

Prior to administration, reconstitute a single-dose vial of lyophilized ActHIB vaccine by adding the entire contents of a single-dose vial of the DTaP-IPV vaccine according to manufacturer’s instructions to provide a combined preparation containing diphtheria, tetanus, pertussis, IPV, and Hib antigens.²²⁴ Shake thoroughly until a cloudy, uniform suspension is obtained.²²⁴

Administer DTaP-IPV/Hib (Pentacel) immediately after reconstitution.²²⁴

Reconstitution (TriHIBit)

When kit containing both DTaP (Tripedia) and Hib vaccine (ActHIB) is used, reconstitute single-dose vial of lyophilized ActHIB vaccine by adding 0.6 mL of the Tripedia vaccine according to manufacturer’s instructions to provide a combined preparation containing antigens to diphtheria, tetanus, pertussis, and Hib (DTaP/Hib).¹⁶⁴ Agitate thoroughly.¹⁶⁴ Administer immediately (within 30 minutes) after reconstitution.¹⁶⁴

Dosage

DTaP (Daptacel, Infanrix, Tripedia) is used only in children 6 weeks through 6 years of age.¹⁰⁰ ¹⁴⁸ ¹⁴⁹ ¹⁵² ¹⁸² ¹⁸⁷

Tdap (Boostrix) is labeled by FDA for use in adolescents and adults ≥10 years of age.¹⁹³ ¹⁹⁵ ¹⁹⁶

Tdap (Adacel) is labeled by FDA for use in adolescents and adults 11 through 64 years of age.¹⁹² ¹⁹⁵ ¹⁹⁶

DTaP-IPV (Kinrix) is used only in children 4 years through 6 years of age.²²³

DTaP-HepB-IPV (Pediarix) is used only in children 6 weeks through 6 years of age.¹⁰⁹

DTaP-IPV/Hib (Pentacel) is used only in children 6 weeks through 4 years of age.²²⁴

TriHIBit kit containing both DTaP (Tripedia) and Hib vaccine (ActHIB) is used only when both a fourth dose of DTaP and a fourth dose of Hib vaccine both are indicated in a child 15 through 18 months of age.¹⁶⁴

Only limited data exist regarding safety, efficacy, or immunogenicity of different DTaP vaccines administered interchangeably in the primary or booster immunization series.¹⁰⁰ ¹²⁷ ¹³⁴ ¹⁴⁹ ¹⁸³ ¹⁹⁰ ACIP recommends that the same DTaP preparation used for the initial dose be used to complete the primary and booster immunization series whenever possible.¹²⁷ ¹³⁴ ¹⁴⁹ ¹⁸³ However, if the health-care provider does not know or have available the particular DTaP vaccine used previously in a child, any of the commercially available DTaP vaccines may be used to complete the immunization series.¹⁰⁰ ¹²⁷ ¹³⁴ ¹⁴⁹ ¹⁸³ There are no data to date indicating that any one DTaP preparation is preferred over any other DTaP preparation in terms of safety or efficacy.¹⁸³

Medically stable preterm and low birthweight infants generally should be vaccinated at the usual chronologic age using usual dosage.²⁰⁷ (See Pediatric Precautions under Cautions.)

Interruption of the recommended immunization schedule, regardless of length of time between doses, does not interfere with the final immunity achieved; it is not necessary to give additional doses or start the vaccine series over.¹¹¹ ¹⁹² ¹⁹³ ¹⁹⁸ ¹⁹⁹

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 DTaP are 4 weeks; minimum intervals between third, fourth, and fifth doses are 6 months.¹¹⁵ ¹²¹ ¹⁹⁹

In adolescents and adults 11 through 64 years of age, an interval of at least 5 years usually is recommended between Tdap (Adacel, Boostrix) and the last dose of any vaccine containing diphtheria, tetanus, or pertussis antigens.¹⁹² ¹⁹⁵ ¹⁹⁶ ²⁰⁵ However, if Tdap is indicated in health-care personnel or is indicated for pertussis vaccination in adolescents or adults who have or anticipate having close contact with an infant <12 months of age (e.g., parents, siblings, grandparents, childcare provider) or prior to travel, give Tdap regardless of the interval since the last dose of vaccine containing tetanus or diphtheria antigens (e.g., Td).¹¹⁵ ²³⁵ ²³⁶

Pediatric Patients

Prevention of Diphtheria, Tetanus, and Pertussis

Infants and Children 6 Weeks Through 6 Years of Age (DTaP; Daptacel, Infanrix, Tripedia)

Primary immunization consists of a series of 3 primary doses and 1 or 2 booster doses.¹⁰⁰ ¹⁴⁸ ¹⁵² ¹⁵² ¹⁸² Each dose is 0.5 mL.¹⁴⁸ ¹⁴⁹ ¹⁵²

ACIP, AAP, and AAFP recommend that the first 4 doses be administered at 2, 4, 6, and 15 through 18 months of age.¹⁰⁰ ¹⁹⁹ Fourth (booster) dose may be given as early as 12 months of age, provided at least 6 months have elapsed since the third dose.¹⁰⁰ ¹⁹⁹

At 4 through 6 years of age (usually just prior to entry into kindergarten or elementary school), give a fifth (booster) dose to those who received the fourth dose of the series at <4 years of age.¹⁰⁰ ¹⁵² ¹⁸² ¹⁹⁹ Fifth dose not necessary if fourth dose was given at ≥4 years of age.¹⁰⁰ ¹⁵²

If pertussis is prevalent in the community or preexposure immunization is required prior to travel, vaccination series may be initiated as early as 6 weeks of age and a minimum interval of 4 weeks can be used between the first 3 doses.¹⁰⁰ ¹¹⁵

If accelerated vaccination 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.¹⁰⁰ ¹¹⁵ ¹⁹⁹ Fifth dose not necessary if fourth dose was given at ≥4 years of age.¹⁰⁰ ¹⁵² ¹⁸² ¹⁹⁹

Children 4 through 6 Years of Age (DTaP-IPV; Kinrix)

Each dose is 0.5 mL.²²³

May be used when immunization against diphtheria, tetanus, pertussis, and poliovirus is indicated in children 4 through 6 years of age.²²³

Used to provide the fifth dose of the DTaP vaccination series and the fourth dose of the IPV vaccination series in children 4 through 6 years of age receiving primary immunization with Infanrix (DTaP) and/or Pediarix (DTaP-HepB-IPV).²²³

Infants and Children 6 Weeks through 4 Years of Age (DTaP-IPV/Hib; Pentacel)

Each dose is 0.5 mL.²²⁴

May be used when immunization against diphtheria, tetanus, pertussis, poliovirus, and Hib is indicated in children 6 weeks through 4 years of age.²²⁴

In previously unvaccinated children 6 weeks through 4 years of age, Pentacel is given in a series of 4 doses.²²⁴ Give doses at 2, 4, 6, and 15 through 18 months of age.²²⁴ Initial dose usually given at 2 months of age, but may be given as early as 6 weeks of age.²²⁴

To complete the recommended primary and booster regimen against diphtheria, tetanus, and pertussis in children who received the 4-dose regimen of Pentacel at 2, 4, 6, and 15 through 18 months of age, give a fifth dose of DTaP (Daptacel) at 4 through 6 years of age.²²⁴ Pentacel should not be used for the booster dose of DTaP indicated at 4 through 6 years of age; however, if a dose of Pentacel is inadvertently given to a child ≥5 years of age, ACIP states the dose may be counted as a valid dose.²²⁵

To complete vaccination against poliovirus in children who received the 4-dose regimen of Pentacel at 2, 4, 6, and 15 through 18 months of age, give an additional booster dose of age-appropriate vaccine containing IPV (IPOL or Kinrix) at 4 through 6 years of age.²²⁴ ²³¹ This results in a 5-dose series of IPV, which is considered acceptable by ACIP.²³¹ To ensure an optimum booster response, the minimum interval between the fourth dose of Pentacel and fifth IPV dose should be 6 months.²³¹

In infants and children 6 weeks through 4 years of age who previously received 1 or more doses of DTaP (Daptacel), Pentacel can be used to complete the DTaP series if doses of IPV and Hib vaccine also are indicated and there are no contraindications to any of the individual components.²²⁴

In infants and children 6 weeks through 4 years of age who previously received 1 or more doses of IPV, Pentacel can be used to complete the IPV series if doses of DTaP and Hib vaccine also are indicated and there are no contraindications to any of the individual components.²²⁴ ²²⁵

In infants and children 6 weeks through 4 years of age who previously received 1 or more doses of Hib vaccine, Pentacel can be used to complete the Hib series when doses of IPV and DTaP also are indicated and there are no contraindications to any of the individual components.²²⁴ If Hib vaccines from different manufacturers are used to complete the series, a total of 4 doses of vaccine containing Hib antigen (3 primary and a booster dose) are necessary.²²⁴

Infants and Children 6 Weeks through 6 Years of Age (DTaP-HepB-IPV; Pediarix)

Each dose is 0.5 mL.¹⁰⁹

May be used when immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliovirus is indicated in children 6 weeks through 6 years of age born to HBsAg-negative women.¹⁰⁹ ACIP states this fixed-combination vaccine also may be used to complete the HBV vaccine series in infants 6 weeks through 6 years of age or older born to HBsAg-positive women†.²⁰⁸

In previously unvaccinated infants and children 6 weeks through 6 years of age, Pediarix is given in a series of 3 doses.¹⁰⁹ Give doses at 2, 4, and 6 months of age (at 6- to 8-week intervals, preferably 8-week intervals).¹⁰⁹ Initial dose usually given at 2 months of age, but may be given as early as 6 weeks of age.¹⁰⁹

To complete the recommended primary and booster regimen against diphtheria, tetanus, and pertussis in children who received a 3-dose series of Pediarix, administer a fourth or fifth dose of DTaP if indicated.¹⁰⁹ Manufacturer recommends that Infanrix be used for the fourth dose of DTaP at 15 through 18 months of age and either Infanrix DTaP or DTaP-IPV (Kinrix) be used as the fifth dose of DTaP at 4 through 6 years of age since these vaccines contain the same pertussis antigens as Pediarix.¹⁰⁹ ²²³

To complete vaccination against poliovirus in children who received a 3-dose series of Pediarix, administer a dose of monovalent IPV (IPOL) at 4 through 6 years of age.¹⁰⁹ ¹⁹⁹

In infants and children 6 weeks through 6 years of age who previously received 1 or 2 doses of Infanrix DTaP,¹⁰⁹ Pediarix may be used to complete the first 3 doses of the DTaP vaccine series if doses of IPV and HepB vaccine also are indicated and there are no contraindications to any of the individuals components.¹⁰⁹ Data are not available regarding the safety and efficacy of Pediarix used following 1 or more doses of DTaP vaccines from other manufacturers.¹⁰⁹

In infants and children 6 weeks through 6 years of age who previously received 1 or 2 doses of IPV from a different manufacturer, Pediarix can be used to complete the first 3 doses of the IPV series if doses of DTaP and HepB vaccine also are indicated and there are no contraindications to any of the individual components.¹⁰⁹

In infants and children 6 weeks through 6 years of age who previously received 1 or 2 doses of another HepB vaccine (monovalent or combination vaccine), Pediarix may be used to complete the 3-dose HepB vaccine series if doses of IPV and DTaP also are indicated and there are no contraindications to any of the individual components.¹⁰⁹ Do not use for the initial dose of HepB vaccine that is indicated in neonates.¹⁰⁰ ¹⁰⁹ Although a 3-dose series of Pediarix may be used in infants who received a dose of HepB vaccine at or shortly after birth,¹⁰⁹ manufacturer states data are limited regarding the safety of the vaccine in such infants.¹⁰⁹ Data are not available to support the use of a 3-dose series of Pediarix in those who previously received >1 dose of HepB vaccine.¹⁰⁹

Infants 15 through 18 Months of Age (DTaP/Hib; TriHIBit)

Usual dose is 0.5 mL.¹⁶⁴

May be used whenever a fourth dose of DTaP is indicated in addition to a fourth dose of Hib vaccine in children 15 through 18 months of age.¹⁴⁹ ¹⁵² ¹⁶⁴ ACIP, AAP, and AAFP state may be used in children >12 months of age, provided at least 6 months have elapsed since the last DTaP dose.¹⁹⁹

Do not use for first 3 doses of the primary series.¹⁴⁸ ¹⁴⁹ ¹⁵² ¹⁶⁴

Previously Unvaccinated Children 7 through 10 Years of Age† (Tdap; Adacel, Boostrix)

Usual dose is 0.5 mL.¹⁹² ¹⁹³

Although safety and efficacy of Tdap for primary immunization not established,¹⁹² ¹⁹³ ACIP recommends that primary immunization† in previously unvaccinated or incompletely vaccinated children 7 through 10 years of age† include a single dose of Tdap, unless pertussis antigens are contraindicated or should not be used.²³⁶

Preferred primary immunization schedule for catch-up vaccination in previously unvaccinated children 7 through 10 years of age is a single dose of Tdap 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 of Age (Tdap; Adacel, Boostrix)

Usual dose is 0.5 mL.¹⁹² ¹⁹³

Although safety and efficacy of Tdap for primary immunization not established,¹⁹² ¹⁹³ ACIP recommends that primary immunization† in previously unvaccinated or incompletely vaccinated adolescents 11 through 18 years of age include a single dose of Tdap, unless pertussis antigens are contraindicated or should not be used.¹⁹⁵ ¹⁹⁶

Preferred primary immunization schedule for catch-up vaccination in previously unvaccinated adolescents 11 through 18 years of age is a single dose of Tdap 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.¹⁹⁵ ¹⁹⁶

Booster Doses in Adolescents 10 through 18 Years of Age (Tdap; Adacel, Boostrix)

Usual dose is 0.5 mL.¹⁹² ¹⁹³

Boostrix is labeled for use in adolescents ≥10 years of age;¹⁹³ Adacel is labeled for use in adolescents ≥11years of age.¹⁹²

To maintain adequate immunity against diphtheria and tetanus, ACIP, AAP, and AAFP recommend that all individuals who received primary immunization with any preparation containing diphtheria and tetanus toxoids (DTaP, DTP [not commercially available in the US], DT, or Td) 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.¹⁰⁰ ¹¹¹ ¹⁹⁹ A booster dose can be given at 11 through 18 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, HepB vaccine, varicella virus vaccine live, meningococcal vaccine).¹⁰⁰ ¹¹¹ ¹⁹⁹

Because adolescents also may be at risk for pertussis, ACIP, AAP, and AAFP recommend that a dose of Tdap be used instead of Td for the adolescent booster dose given at 11 through 18 years of age, unless pertussis antigens are contraindicated or should not be used.¹⁹⁵ ¹⁹⁹ ²⁰¹ ²³⁶ If Tdap is unavailable or was administered previously, the usually recommended dose of Td should be used for this adolescent booster dose.¹⁹⁵ ¹⁹⁹ ²⁰¹

In adolescents who have or anticipate having close contact with an infant <12 months of age, give Tdap at least 2 weeks before beginning close contact with the infant²³⁴ and administer regardless of interval since last dose of vaccine containing diphtheria or tetanus antigens (e.g., Td).²³⁶

Postexposure Prophylaxis of Tetanus

An emergency dose of a preparation containing tetanus toxoid adsorbed may be indicated with or without a dose of TIG.¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁶ ¹⁹⁸ ²⁰¹ (See Postexposure Prophylaxis of Tetanus under Uses.)

Wound care is an essential part of postexposure prophylaxis of tetanus.¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁶ ¹⁹⁸ Wound care is necessary regardless of vaccination status.¹⁰⁰ ¹¹¹ Clean and debride wounds properly, especially if dirt or necrotic tissue is present; remove all necrotic tissue and foreign material.¹⁰⁰

Adolescents 10 through 18 Years of Age (Tdap; Adacel, Boostrix)

Usual dose is 0.5 mL.¹⁰⁰ ¹¹¹ ¹⁹² ¹⁹³

Boostrix is labeled for use in adolescents ≥10 years of age;¹⁹³ Adacel is labeled for use in adolescents ≥11 years of age.¹⁹²

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.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸

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.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸ If injury is extensive (moderately or very tetanus prone), give an emergency booster dose of an age-appropriate preparation containing tetanus toxoid absorbed if >5 years have elapsed since primary immunization against tetanus or the last booster dose.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸

For most individuals, a dose of Td is indicated for these booster doses.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸ However, if the individual has not previously received a dose of Tdap, a single dose of Tdap should be used instead of a booster dose of Td.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸ If Tdap is not available or was administered previously, use Td.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸

Postexposure Prophylaxis of Diphtheria

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

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 adsorbed and complete the primary vaccination series.¹⁰⁰ ¹¹¹ ¹⁹⁸

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 adsorbed.¹⁰⁰ ¹¹¹ ¹⁹⁸

Used as an adjunct to anti-infective postexposure prophylaxis.¹⁰⁰ ¹¹¹ ¹⁹⁸ (See Postexposure Prophylaxis of Diphtheria under Uses.)

Postexposure Prophylaxis of Pertussis

Infants and Children 6 Weeks Through 6 Years of Age (DTaP; Daptacel, Infanrix, Tripedia)

Household and other close contacts of an individual with pertussis who have not completed primary immunization with DTaP: Complete the vaccination series with minimal intervals between doses.¹⁰⁰ ¹¹¹ ¹⁹⁸ Give a fourth dose of DTaP to those who received their third DTaP dose ≥6 months before the exposure;¹⁰⁰ give a fifth dose to those who received their fourth dose ≥3 years before the exposure.¹⁰⁰

Used as an adjunct to anti-infective postexposure prophylaxis.¹⁰⁰ ¹¹¹ ¹⁹⁸ (See Postexposure Prophylaxis of Pertussis under Uses.)

Adolescents 10 through 18 Years of Age (Tdap; Adacel, Boostrix)

Individuals at increased risk of pertussis because of pertussis outbreaks or because they are close contacts of an individual with pertussis: Consider a booster dose of Tdap (0.5 mL) in those who have not previously received a dose.¹⁰⁰ ¹⁹⁵ ¹⁹⁶ ¹⁹⁸ ²⁰¹

Used as an adjunct to anti-infective postexposure prophylaxis.¹⁰⁰ ¹¹¹ ¹⁹⁸ (See Postexposure Prophylaxis of Pertussis under Uses.)

Adults

Prevention of Diphtheria, Tetanus, and Pertussis

Primary Immunization in Adults 19 through 64 Years of Age† (Tdap; Adacel, Boostrix)

Usual dose is 0.5 mL.¹⁹⁵ ¹⁹⁶

Although safety and efficacy of Tdap for primary immunization have not been established,¹⁹² ¹⁹³ ACIP recommends that primary immunization† against diphtheria and tetanus in previously unvaccinated adults 19 through 64 years of age include a single dose of Tdap, unless pertussis antigens are contraindicated or should not be used.¹⁹⁵ ¹⁹⁶

ACIP states that the preferred primary immunization schedule in these individuals is a single dose of Tdap followed by a dose of Td given at least 4 weeks after the Tdap dose and a second dose of Td given 6–12 months after the first dose of Td; however, the Tdap dose may be substituted for any 1 of the 3 doses of Td.¹⁹⁵ ¹⁹⁶

Booster Doses in Adults 19 through 64 Years of Age (Tdap; Adacel, Boostrix)

Usual dose is 0.5 mL.¹⁹² ¹⁹³

Adults who have received primary immunization against diphtheria and tetanus should receive routine booster doses of Td every 10 years.¹¹¹ ²⁰⁰ In addition, an emergency booster dose of Td may be indicated in the event of injury and possible exposure to tetanus infection.¹¹¹

However, because adults may be at risk for pertussis, the ACIP recommends that a single dose of Tdap be used instead of a dose of Td when a booster dose is needed in adults 19 through 64 years of age, unless pertussis antigens are contraindicated or should not be used.¹⁹⁶

In adults 19 through 64 years of age who have not previously received a dose of Tdap and who have or anticipate having close contact with an infant <12 months of age, give Tdap at least 2 weeks before beginning close contact with the infant²³⁴ and administer regardless of interval since last dose of vaccine containing diphtheria or tetanus antigens (e.g., Td).²³⁶

A booster dose of Tdap should only be used in adults 19 through 64 years of age who have not previously received a dose of Tdap.¹⁹⁶ If Tdap is not available or was administered previously, Td should be used for booster doses.¹⁹⁶

Booster Doses in Adults ≥65 Years of Age (Tdap; Adacel, Boostrix)

Usual dose is 0.5 mL.¹⁹³

In adults ≥65 years of age who have not previously received a dose of Tdap and who have or anticipate having close contact with an infant <12 months of age, give Tdap at least 2 weeks before beginning close contact with the infant.²³⁴ In such individuals or others in this age group who have not previously received Tdap, administer Tdap regardless of interval since last dose of vaccine containing diphtheria or tetanus antigens (e.g., Td).²³⁶

Although only Boostrix is labeled for use in adults ≥65 years of age, ACIP states that either Adacel or Boostrix can be used when a dose of Tdap is indicated in this age group.²³⁶

Individuals who have received a dose of Tdap should receive Td for subsequent booster doses.²³⁶

Postexposure Prophylaxis of Tetanus

An emergency dose of a preparation containing tetanus toxoid adsorbed may be indicated with or without a dose of TIG.¹⁰⁰ ¹¹¹ ¹⁹² ¹⁹³ (See Postexposure Prophylaxis of Tetanus under Uses.)

Adults 19 through 64 Years of Age (Tdap; Adacel, Boostrix)

Usual dose is 0.5 mL.¹⁰⁰ ¹¹¹ ¹⁹²

For most individuals, a dose of Td is indicated for these booster doses.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸ However, if individuals 19 through 64 years of age have not previously received a dose of Tdap, a single dose of Tdap should be used instead of a booster dose of Td.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸ If Tdap is not available or was administered previously, use Td.¹⁰⁰ ¹¹¹ ¹⁹⁶ ¹⁹⁸

Postexposure Prophylaxis of Diphtheria

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

Used as an adjunct to anti-infective postexposure prophylaxis.¹⁰⁰ ¹¹¹ ¹⁹⁸ (See Postexposure Prophylaxis of Diphtheria under Uses.)

Postexposure Prophylaxis of Pertussis

Adults 19 through 64 Years of Age (Tdap; Adacel, Boostrix)

Used as an adjunct to anti-infective postexposure prophylaxis.¹⁰⁰ ¹¹¹ ¹⁹⁸ (See Postexposure Prophylaxis of Pertussis 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 and Acellular Pertussis Vaccine Adsorbed, Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Contraindications

DTaP (Daptacel, Infanrix, Tripedia) or Tdap (Adacel, Boostrix)
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of DTaP, Tdap, or any vaccine containing tetanus, diphtheria, or pertussis antigens.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ (See Sensitivity Reactions under Cautions.)
Hypersensitivity to any component of the vaccine.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³
Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a vaccine containing pertussis antigens that is not attributable to another identifiable cause.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.¹⁵² ¹⁸² ¹⁸⁷ (See Guillain-Barré Syndrome and Other Neurologic Disorders under Cautions.)

Fixed-combination Vaccine Containing DTaP and IPV (DTaP-IPV; Kinrix)
Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine (e.g., neomycin, polymyxin B) or after previous dose of any vaccine containing diphtheria, tetanus, pertussis, or poliovirus antigens.²²³
Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine.²²³
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.²²³

Fixed-combination Vaccine Containing DTaP, HepB, and IPV Vaccines (DTaP-Hib-HepB; Pediarix)
Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine (e.g., yeast, neomycin, polymyxin B) or after previous dose of any vaccine containing diphtheria, tetanus, pertussis, hepatitis B, or poliovirus antigens.¹⁰⁹
Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine that is not attributed to another identifiable cause.¹⁰⁹
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.¹⁰⁹

Fixed-combination Vaccine Containing DTaP, IPV, and Hib (DTaP-IPV/Hib; Pentacel)
Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine or after previous dose of the vaccine or any vaccine containing diphtheria, tetanus, pertussis, poliovirus, or Hib antigens.²²⁴
Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine.²²⁴
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy.²²⁴

Warnings/Precautions

Warnings

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.²⁰⁹

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,¹⁵² ¹⁸⁷ ¹⁹² ¹⁹³ ²⁰⁹ ²²⁴ but was inadequate to accept or reject a causal relationship between the toxoids and other neurologic effects.¹⁹² ²⁰⁹ 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.¹⁹⁵ ¹⁹⁶ ²³⁰

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.¹³⁴ ¹⁹⁵ ¹⁹⁶ ACIP does not consider brachial neuritis a precaution or contraindication for further doses.¹³⁴ ¹⁹⁵ ¹⁹⁶

The manufacturers state that, if GBS occurred within 6 weeks of receipt of a vaccine containing tetanus toxoid, a decision to administer a dose of DTaP, Tdap, or combination vaccine containing DTaP should be based on careful consideration of the potential benefits and possible risks.¹⁰⁹ ¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²²³ ²²⁴

The manufacturer of Tdap (Adacel) states that use of the vaccine should be deferred in adolescents with progressive neurologic disorder (including progressive encephalopathy), or uncontrolled epilepsy, until the condition has stabilized.¹⁹² This manufacturers also recommends that use of Tdap be deferred in adults with unstable neurologic condition (e.g., cerebrovascular events and acute encephalopathic conditions) until the condition resolves or stabilizes.¹⁹²

The manufacturer of Tdap (Boostrix) states that deferral of Tdap should be considered in adults or adolescents with progressive or unstable neurologic conditions (e.g., cerebrovascular event, acute encephalopathic condition) since it is not known whether administration in such individuals might hasten manifestations of the disorder or affect prognosis.¹⁹³ Administration in such individuals may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.¹⁹³

Precautions Related to the Pertussis Component

If any of the following events is temporally related to a dose of any vaccine containing pertussis antigens, a decision to give additional doses should be based on careful consideration of potential benefits and possible risks:¹⁰⁹ ¹⁵² ¹⁸² ¹⁸⁷ ²²³ ²²⁴ temperature ≥40.5°C within 48 hours not due to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours; persistent, inconsolable crying lasting ≥3 hours occurring within 48 hours; or seizures with or without fever occur within 3 days.¹⁰⁹ ¹⁵² ¹⁸² ¹⁸⁷ ²²³ ²²⁴

In individuals with stable CNS disorders, a decision to administer a preparation containing pertussis antigens must be made by the clinician on an individual basis, with consideration of all relevant factors and assessment of potential risks and benefits.¹⁸² Advise the patient and/or patient’s parent or guardian of the potential risks.¹⁸²

A family history of seizures or other CNS disorder is not a contraindication to vaccines containing pertussis antigens.¹⁵² ¹⁸²

To reduce the possibility of post-vaccination fever in infants or children with a history of previous seizures or at higher risk for seizures than the general population, some manufacturers suggest that an appropriate antipyretic may be given at the time of vaccination and for the next 24 hours.¹⁰⁹ ¹⁵² ¹⁸² ¹⁸⁷ ²²³ ²²⁴ ACIP states that evidence does not support use of antipyretics before or at the time of vaccination for prevention of febrile seizures, but antipyretics can be used for treatment of fever or local discomfort that might occur following vaccination.¹³⁴

If pertussis vaccine is contraindicated or a decision is made to withhold pertussis vaccine, use an age-appropriate vaccine containing only tetanus and diphtheria toxoids (Td, DT).¹⁵² ¹⁸² ¹⁸⁷

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.¹¹¹ ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³

Prior to injection of DTaP, Tdap, or a combination vaccine containing DTaP, the clinician should review the patient’s history regarding possible sensitivity and any previous adverse reactions and should take all precautions known for prevention of allergic or any other adverse effects.¹⁰⁹ ¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²²³ ²²⁴ Epinephrine and other appropriate agents and equipment should be available for immediate use in case an anaphylactic reaction occurs.¹⁰⁹ ¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²²³ ²²⁴

If a hypersensitivity reaction occurs, no further doses of the vaccine or any other vaccine containing diphtheria toxoid, tetanus toxoid, or pertussis vaccine should be given because of uncertainty regarding which component may have caused the reaction.¹⁰⁰ ¹⁵² ¹⁸⁷ ¹⁹² ¹⁹³ ²²³ ²²⁴ If further doses are being considered (e.g., for tetanus postexposure prophylaxis), consider consultation with an allergist.¹⁸⁷ ¹⁹² ¹⁹³

The AAP states that a transient urticarial rash occurring after DTaP administration (unless it appears within a few minutes after the dose is administered) is unlikely to be anaphylactic in origin and is not a contraindication for further doses.¹⁰⁰

Arthus-type Hypersensitivity Reactions

Arthus-type hypersensitivity reactions to tetanus toxoid reported.¹⁹² ¹⁹⁵ ¹⁹⁶

Reaction is an extensive local inflammatory reaction (vasculitis) that generally begins 2–12 hours after a dose.¹⁹² ¹⁹⁵ ¹⁹⁶ There may be severe pain, swelling, induration, edema, hemorrhage, and necrosis.¹⁹⁵ ¹⁹⁶

Arthus reactions usually resolve without sequelae.¹⁹⁵ ¹⁹⁶

Individuals who have Arthus-type hypersensitivity reactions following a dose of a tetanus toxoid-containing preparation usually have high serum tetanus antitoxin levels and should not receive doses more frequently than every 10 years, even if postexposure prophylaxis against tetanus is indicated.¹⁹² ¹⁹³ ¹⁹⁵ ¹⁹⁶

Allergy to Neomycin or Other Anti-infectives

DTaP-IPV (Kinrix): Contains trace amounts of neomycin (≤0.05 ng) and polymyxin B (≤0.01 ng).²²³ Manufacturer states the vaccine is contraindicated in individuals hypersensitive to neomycin and/or polymyxin B.²²³

DTaP-HepB-IPV (Pediarix): Contains trace amounts of neomycin (≤0.05 ng) and polymyxin B (≤0.01 ng).¹⁰⁹ Manufacturer states the vaccine is contraindicated in individuals hypersensitive to neomycin and/or polymyxin B.¹⁰⁹

DTaP-IPV/Hib (Pentacel): Contains trace amounts of neomycin (<4 pg) and polymyxin B (<4 pg).²²⁴

Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis.¹⁰⁰ ¹³⁴ ACIP and AAP state that vaccines containing trace amounts of neomycin should not be used in individuals with a history of anaphylactic reaction to neomycin, but use of such vaccines may be considered in those with a history of delayed-type neomycin hypersensitivity if benefits of vaccination outweigh risks.¹⁰⁰ ¹³⁴

Allergy to Certain Preservatives

DTaP-IPV (Kinrix): Contains residual formaldehyde (≤100 mcg) from the manufacturing process.²²³

DTaP-HepB-IPV (Pediarix): Contains residual formaldehyde (≤100 mcg) from the manufacturing process.¹⁰⁹

DTaP-IPV/Hib (Pentacel): Contains trace amounts of phenoxyethanol (0.6%) and formaldehyde (≤5 mcg).²²⁴

DTaP/Hib (TriHIBit): Contains residual formaldehyde (≤0.5 mcg) from the manufacturing process.¹⁶⁴

Yeast Allergy

DTaP-HepB-IPV (Pediarix): Manufacturing process for hepatitis B vaccine component involves baker’s yeast (Saccharomyces cerevisiae) and final product contains yeast protein (≤5%).¹⁰⁹ Manufacturer states the vaccine is contraindicated in individuals hypersensitive to yeast.¹⁰⁹

Latex Sensitivity

A packaging component of Tripedia (vial stopper) contains natural rubber latex, which may cause sensitivity reactions in susceptible individuals.¹⁵²

Although vial stoppers on Adacel,¹⁹² Boostrix,¹⁹³ Daptacel,¹⁸⁷ and Infanrix¹⁸² are latex-free, the tip cap and/or rubber plunger of single-dose prefilled syringes of Adacel,¹⁹² Boostrix,¹⁹³ and Infanrix¹⁸² contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.¹⁸² ¹⁹² ¹⁹³

Some components (i.e., tip cap, plunger) of the single-dose prefilled syringes of DTaP-IPV (Kinrix) or DTaP-HepB-IPV (Pediarix) contain dry natural latex and use of these syringes may cause allergic reactions in latex-sensitive individuals;¹⁰⁹ ²²³ the vial stoppers are latex-free.¹⁰⁹ ²²³

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.¹⁰⁰ ¹³³ ¹³⁴ ¹⁵² ¹⁵⁸ Consider possibility that the immune response to the vaccine and efficacy may be reduced in these individuals.¹⁰⁹ ¹⁰⁰ ¹³⁴ ¹⁵² ¹⁵⁸ ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²²³ ²²⁴ (See Specific Drugs under Interactions.)

Recommendations regarding use of DTaP, Tdap, or combination vaccines containing DTaP in HIV-infected individuals are the same as those for individuals who are not HIV-infected.¹⁰⁰ ¹³³ ¹³⁴ ¹⁵⁸ However, immunization may be less effective in individuals with HIV infection than in immunocompetent individuals.¹⁰⁰ ¹⁵⁸

Thimerosal Precautions

USPHS, ACIP, AAP, and AAFP support efforts to minimize exposure to all forms of organic mercury, including thimerosal, a mercury-containing preservative contained in some vaccines and biologics.¹⁰¹ ¹⁰² ¹⁰³ ¹⁰⁴ ¹⁰⁸ Use of vaccines that are thimerosal-free or thimerosal-reduced (i.e., do not contain thimerosal as a preservative but may contain trace amounts from the manufacturing process) is recommended whenever such preparations are available.¹⁰¹ ¹⁰² ¹⁰³ ¹⁰⁴ ¹⁰⁸ FDA states that trace amounts of thimerosal from the manufacturing process are not considered clinically important.¹⁹¹

Adacel, Boostrix, Daptacel, Infanrix, Kinrix, Pediarix, and Pentacel do not contain thimerosal.¹⁰⁹ ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²²³ ²²⁴

Tripedia in single-dose vials is formulated without preservatives, but contains trace amounts of thimerosal from the manufacturing process (≤0.3 mcg of mercury per 0.5-mL dose).¹⁵²

When the kit (TriHIBit) containing both DTaP (Tripedia) and Hib vaccine (ActHIB) is used, the reconstituted vaccine contains trace amounts of thimerosal from the DTaP manufacturing process (≤0.3 mcg of mercury per 0.5-mL dose).¹⁶⁴

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.¹⁰⁰ ¹³⁴ ¹⁷⁹

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).¹⁰⁰ ¹¹¹ ¹⁵² ¹⁷⁹ ¹⁹²

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, some manufacturers recommend that DTaP be used in such individuals only if benefits outweigh risks.¹⁵²

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, tetanus, and pertussis.¹⁵² ¹⁸⁷ ¹⁹² ¹⁹³ ²²⁴

Optimum protection against diphtheria and tetanus is achieved with a primary series of 3 doses of preparations containing diphtheria and tetanus toxoids adsorbed.²⁰⁵

Tdap (Adacel, Boostrix) is indicated for booster immunization; use of Tdap for primary immunization has not been studied.¹⁹² ¹⁹³

Duration of Immunity

Following primary immunization, duration of protection against tetanus usually lasts ≥10 years and some individuals may be protected for life.¹¹¹ ¹⁹⁸ However, antitoxin levels decrease over time and most individuals have levels that are suboptimal 10 years after the last dose.¹⁹⁸ The antitoxin response induced by tetanus toxoid adsorbed has a longer duration than that induced by tetanus toxoid (no longer commercially available in the US).¹⁹⁸

Following primary immunization, protective levels of diphtheria antitoxin may persist for ≥10 years.¹⁹² However, levels decrease over time and are below optimal levels in many individuals 10 years after the last dose.¹⁹⁸

Duration of immunity following primary immunization against pertussis is estimated to be 5–10 years or longer, but protection wanes over time.¹⁰⁰ ¹⁹⁵ ¹⁹⁶ ²⁰¹ ²⁰⁵

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.¹⁹⁵ ¹⁹⁶ 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.¹⁹⁵ ¹⁹⁶

When postexposure prophylaxis against tetanus is indicated or when preexposure vaccination in high-risk groups (e.g., travelers) is indicated, individuals with an uncertain history of vaccination generally should be considered unvaccinated and should receive the full 3-dose primary immunization series.¹¹¹ ¹¹⁵ ¹⁹⁵ Routine prevaccination serologic testing is not recommended in these individuals.¹⁹⁵ ¹⁹⁶

Use of Fixed Combinations

When the fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix) is used, consider the cautions and precautions associated with each antigen.²²³

When the combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel) is used, consider the cautions and precautions associated with each antigen.²²⁴

When the fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B virus, and poliovirus antigens (DTaP-HepB-IPV; Pediarix) is used, consider the cautions and precautions associated with each antigen.¹⁰⁹

When the combination vaccine containing diphtheria, tetanus, pertussis, and Hib antigens (DTaP/Hib; TriHIBit) is used, consider the cautions and precautions associated with each antigen.¹⁵² ¹⁶⁴

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.²⁰³

Do not administer DTaP, Tdap, or combination vaccines containing DTaP that have been mishandled or have not been stored at the recommended temperature.²⁰³ (See Storage under Stability.)

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.²⁰³ If there are concerns about mishandling, the manufacturer or state or local health departments should be contacted for guidance on whether the vaccine is usable.²⁰³

Specific Populations

Pregnancy

TDaP (Daptacel, Infanrix, Tripedia): Category C.¹⁵² ¹⁸² ¹⁸⁷ Not indicated for women of childbearing age.¹⁵² ¹⁸²

Tdap (Adacel, Boostrix): Category C.¹⁹² ¹⁹³

DTaP-IPV (Kinrix), DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel), and TrHIBit: Category C.¹⁰⁹ ¹⁶⁴ ²²³ ²²⁴ These combination vaccines are not indicated for use in adults, including pregnant women.¹⁰⁹ ¹⁶⁴ ²²³ ²²⁴

Because of the risks associated with tetanus, diphtheria, and pertussis infection, ACIP and AAP state that pregnancy is not generally considered a contraindication for Tdap (Adacel, Boostrix).¹⁹⁵ ¹⁹⁶ ²⁰¹ ²⁰⁵ ²³⁴

Ideally, primary immunization against tetanus and diphtheria should be completed prior to pregnancy¹⁰⁰ ¹¹¹ ¹⁹⁵ ²⁰⁵ and females of childbearing age who have not previously received a dose of Tdap should receive a single dose of Tdap instead of a routine booster dose of Td during a preconception wellness visit.¹⁹⁵ ²⁰⁵

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.²⁰⁵ ²³⁴ In most situations, Td is the preferred preparation for primary or booster immunization against diphtheria and tetanus during pregnancy.¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁶ ²⁰⁰ ²⁰⁵ 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).¹⁰⁰ ¹¹¹ ¹⁹⁵ ¹⁹⁶ ²⁰⁵ 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

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

Clinicians are encouraged to register pregnant women who receive Tdap with the manufacturer’s pregnancy registry at 800-822-2463 (Adacel) or 888-452-9622 (Boostrix).¹⁹² ¹⁹³ ²⁰⁵

Lactation

Tdap (Adacel, Boostrix): Not known whether distributed into milk.¹⁹² ¹⁹³ Manufacturers recommend caution in nursing women.¹⁹² ¹⁹³ ACIP states breast-feeding is not considered a contraindication for Tdap.²⁰⁵

Pediatric Use

DTaP (Daptacel, Infanrix, Tripedia): Safety and efficacy not established in infants <6 weeks of age or in children ≥7 years of age.¹⁵² ¹⁸² ¹⁸⁷

Tdap (Adacel): Safety and efficacy not established in children <11 years of age.¹⁹²

Tdap (Boostrix): Safety and efficacy not established in children <10 years of age.¹⁹³

DTaP-IPV (Kinrix): Safety and efficacy not established in children <4 years of age or in children ≥7 years of age.²²³

DTaP-HepB-IPV (Pediarix): Safety and efficacy in infants 6 weeks through 6 months of age were established on the basis of clinical studies; safety and efficacy in those 7 months through 6 years of age are supported by evidence in infants 6 weeks through 6 months of age.¹⁰⁹ Safety and efficacy not established in infants <6 weeks of age or in children ≥7 years of age.¹⁰⁹

DTaP-IPV/Hib (Pentacel): Safety and efficacy not established in infants <6 weeks of age or in children ≥5 years of age.²²⁴

Apnea has been reported following IM administration of vaccines in some infants born prematurely.¹⁰⁹ ¹⁸² Base decisions regarding when to administer an IM vaccine in infants born prematurely on consideration of the individual infant’s medical status and potential benefits and possible risks of vaccination.¹⁰⁹ ¹⁸²

Geriatric Use

DTaP (Daptacel, Infanrix, Tripedia): Not indicated in adults, including geriatric adults.¹⁰⁰ ¹⁴⁸ ¹⁴⁹ ¹⁵² ¹⁸² ¹⁸⁷

Tdap (Boostrix): Clinical studies included adults ≥65 years of age; safety and efficacy established in this age group.¹⁹³

Tdap (Adacel): Safety and efficacy not established in adults ≥65 years of age.¹⁹²

DTaP-IPV (Kinrix), DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel), and TriHIBit are not indicated for use in adults, including geriatric adults.¹⁰⁹ ¹⁶⁴ ²²³ ²²⁴

Common Adverse Effects

DTaP (Daptacel, Infanrix, Tripedia): Injection site reactions (pain or tenderness,¹²⁷ ¹⁵² ¹⁸² erythema,¹²⁷ ¹⁵² ¹⁸² induration,¹⁵² swelling),¹²⁷ ¹⁵² ¹⁸² mild to moderate fever (38–40.4°),¹⁸² ¹⁸⁷ fretfulness or irritability,¹⁸² ¹⁸⁷ drowsiness,¹⁸² ¹⁸⁷ anorexia,¹⁸⁷ vomiting.¹⁸⁷

Tdap (Adacel, Boostrix): Injection site reactions (pain, erythema, swelling), headache, fatigue, sore and swollen joints, GI effects (nausea, diarrhea, vomiting, abdominal pain), chills, fever, rash.¹⁹² ¹⁹³

DTaP-IPV (Kinrix): Injection site reactions (pain, redness, increase in arm circumference, swelling), drowsiness, fever, loss of appetite.²²³

DTaP-HepB-IPV (Pediarix): Injection site reactions (pain, erythema, swelling), fever, drowsiness, fussiness/irritability, loss of appetite.¹⁰⁹

DTaP-IPV/Hib (Pentacel): Injection site reactions (tenderness, redness, swelling, increased circumference of injected arm), fever, decreased activity/lethargy, inconsolable crying, fussiness/irritability.²²⁴

Interactions for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Other Vaccines

Although specific data not available regarding concurrent administration of DTaP or Tdap with all other available vaccines, primary immunization against diphtheria, tetanus, and pertussis can be integrated with primary immunization against Haemophilus influenzae type b (Hib), hepatitis A, hepatitis B, human papillomavirus (HPV) influenza, measles, mumps, rubella, meningococcal disease, pneumococcal disease, poliomyelitis, rotavirus, and varicella.¹⁰⁰ ¹¹¹ ¹³⁴ ¹⁹² ¹⁹³ ¹⁹⁵ ¹⁹⁶ ¹⁹⁹ However, unless commercially available combination vaccines appropriate for the age and vaccination status of the recipient are used, each parenteral vaccine should be administered using a different syringe and different injection site.¹⁰⁰ ¹¹¹ ¹³⁴ ¹⁸² ¹⁹² ¹⁹³ ¹⁹⁵ ¹⁹⁶ ¹⁹⁹ ²²⁴

DTaP or Tdap may be administered simultaneously with or at any interval before or after live viral vaccines, including measles, mumps, and rubella vaccine (MMR).¹⁰⁰ ¹³⁴ In addition, DTaP or Tdap may be administered simultaneously with or at any interval before or after inactivated vaccines, including Hib vaccine, HepB vaccine, and poliovirus vaccine inactivated (IPV).¹⁰⁰ ¹³⁴

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 adsorbed¹¹¹	DTaP or Tdap may be administered simultaneously using different syringes and different injection sites¹¹¹
Hepatitis B (HepB) vaccine	Concomitant administration of DTaP or Tdap and HepB vaccine does not result in reduced antibody responses to either vaccine¹⁴⁸ ¹⁴⁹ ¹⁸² ¹⁹²	DTaP or Tdap may be administered simultaneously with (using different syringes and injection sites) or at any time before or after HepB vaccine¹⁰⁰ ¹³⁴ ¹⁴⁹ ¹⁸² ¹⁹²
Hib vaccine	Concomitant administration of DTaP and Hib vaccine does not result in reduced antibody responses to either vaccine¹⁵² ¹⁸²	DTaP or Tdap may be administered simultaneously with (either as TriHIBit or as individual vaccines using different syringes and injection sites) or at any time before or after Hib vaccine¹⁰⁰ ¹³⁴ ¹³⁵ ¹³⁶ ¹⁵² ¹⁵⁹ ¹⁶⁰ ¹⁶⁴
Human papillomavirus (HPV) vaccine	HPV4 (Gardasil): Concomitant administration of Tdap (Adacel), HPV4 (Gardasil), and MCV4 (Menactra) in boys and girls 10 through 17 years of age at 3 different injection sites did not interfere with the antibody response to any of the vaccine antigens²³² ²³³ Although overall incidence of injection site and systemic adverse reactions reported when all 3 vaccines were given concomitantly at different sites was similar to that reported when HPV4 (Gardasil) was given alone followed by Tdap (Adacel) and MCV4 (Menactra) given concomitantly at different sites 1 month later,²³³ concomitant administration of all 3 vaccines was associated with an increased incidence of swelling at the HPV4 (Gardasil) injection site²³² ²³³ and an increased incidence of bruising or pain at the other injection sites²³³	HPV4 (Gardasil): May be administered simultaneously with Tdap (Adacel) using different syringes and injection sites²³²
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 with (using different syringes and injection sites) or at any time before or after immune globulin or specific hyperimmune globulin¹¹¹ ¹³⁴ ¹⁵² ¹⁸² ¹⁹² ¹⁹³ For postexposure prophylaxis in wound management, active immunization against tetanus (if indicated) with DTaP or Tdap should be initiated at the same time as passive immunization with TIG; however, TIG should be given at a separate site using a different syringe¹⁰⁰ ¹¹¹ ¹³⁴ ¹⁵² ¹⁸² ¹⁹² ¹⁹³ ¹⁹⁵ ¹⁹⁶
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)	Individuals receiving immunosuppressive agents may have a diminished immunologic response to DTaP or Tdap¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ 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 dosages¹³⁴ ¹⁵⁸ ¹⁷⁹	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 required²⁰⁹
Influenza vaccine	Parenteral inactivated influenza vaccine (Fluzone): Concurrent administration with Tdap (Adacel) did not result in reduced antibody responses to any of the antigens¹⁹² Parenteral inactivated influenza vaccine (Fluarix): Concurrent administration with Tdap (Boostrix) in adults 19–64 years of age did not affect immune responses to the diphtheria, tetanus, and influenza antigens or the pertussis toxin antigen, but immune responses to the pertussis filamentous hemagglutinin (FHA) and pertactin antigens were reduced compared with administration 1 month apart;¹⁹³ not known if efficacy is affected by the reduced response to these pertussis antigens¹⁹³	DTaP or Tdap may be administered simultaneously with (using different syringes and injection sites) or at any time before or after parenteral inactivated influenza vaccine¹⁰⁰ ¹³⁴
Measles, mumps, and rubella vaccine (MMR)		DTaP may be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after MMR¹³⁴ ¹⁴⁸ ¹⁴⁹ ¹⁵⁰ ¹⁵² ¹⁹⁹
Meningococcal vaccine	MCV4 (Menactra): Concomitant administration of Tdap (Adacel), HPV4 (Gardasil), and MCV4 (Menactra) in boys and girls 10 through 17 years of age at 3 different injection sites did not interfere with the antibody response to any of the vaccine antigens;²³² overall incidence of injection site and systemic adverse reactions reported when all 3 vaccines were given concomitantly at different sites was similar to that reported when HPV4 (Gardasil) was given alone followed by Tdap (Adacel) and MCV4 (Menactra) given concomitantly at different sites 1 month later,²³³ but concomitant administration of all 3 vaccines was associated with an increased incidence of swelling at the HPV4 (Gardasil) injection site²³² ²³³ and an increased incidence of bruising or pain at the other injection sites²³³ MCV4 (Menactra): Concurrent administration of Tdap (Boostrix) and MCV4 in adolescents 11–18 years of age did not affect immune responses to the diphtheria, tetanus, and meningococcal antigens, but immune response to the pertactin pertussis antigen was lower compared with administration 1 month apart; not known if efficacy is affected by the reduced response to pertactin¹⁹³	MCV4 (Menactra): May be administered concurrently with Tdap (using different syringes and different injection sites); ACIP states the vaccines may be given at any interval before or after Tdap;¹⁹⁵ ¹⁹⁶ ²⁰¹ AAP states if the vaccines are not given concurrently, they should be given 1 month apart²⁰¹
Pneumococcal vaccine	PCV13 ( Prevnar 13): No evidence of reduced antibody responses to any of the antigens or increased adverse effects¹⁸⁶ PPSV23 (Pneumovax 23): Does not reduce antibody response to DTaP and does not increase severity of adverse reactions¹⁰⁰	PCV13 (Prevnar 13): May be administered concurrently with DTaP (using different syringes and different injection sites)¹³⁴ ¹⁸⁶
Poliovirus vaccine	Although data regarding the immunologic response are not available, IPV has been safely administered concurrently (at a separate site) with Infanrix¹⁸²	DTaP may be administered concomitantly with IPV¹³⁴ ¹⁴⁸ ¹⁴⁹ ¹⁵⁰ ¹⁵²

Stability

Storage

Parenteral

For Injectable Suspension, for IM Use

DTaP-IPV/Hib (Pentacel): 2–8°C.²²⁴ Do not freeze; if freezing occurs, discard vaccine.²²⁴

Use immediately after reconstitution.²²⁴

Pentacel does not contain thimerosal or any other preservatives.²²⁴

Injectable Suspension, for IM Use

DTaP (Daptacel, Infanrix, Tripedia): 2–8°C.¹⁶⁴ ¹⁸² ¹⁸⁷ ²⁰³ Do not freeze;¹⁶⁴ ¹⁸² ¹⁸⁷ ²⁰³ if freezing occurs, discard vaccine.¹⁸² ¹⁸⁷

Tdap (Adacel, Boostrix): 2–8°C.¹⁹² ¹⁹³ ²⁰³ Do not freeze; if freezing occurs, discard vaccine.¹⁹² ¹⁹³

DTaP-IPV (Kinrix): 2–8°C.²²³ Do not freeze; if freezing occurs, discard vaccine.²²³

DTaP-HepB-IPV (Pediarix): 2–8°C.¹⁰⁹ Do not freeze; if freezing occurs, discard vaccine.¹⁰⁹

Kit containing Tripedia and ActHIB (TriHIBit): 2–8°C; do not freeze.¹⁶⁴ ²⁰³

Adacel, Boostrix, Daptacel, Infanrix, Kinrix, and Pediarix do not contain thimerosal or any other preservative.¹⁰⁹ ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²²³

Actions

Diphtheria and tetanus toxoids adsorbed and acellular pertussis vaccine adsorbed (DTaP) and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) are sterile suspensions prepared by mixing suitable quantities of diphtheria and tetanus toxoids and acellular pertussis antigens which have been formaldehyde-treated, purified, and adsorbed onto an aluminum adjuvant.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³
Currently, there are 3 different DTaP preparations commercially available in the US (Daptacel, Infanrix, Tripedia).¹⁵² ¹⁸² ¹⁸⁷ These preparations contain similar diphtheria and tetanus toxoids, but slightly different acellular pertussis vaccine components.¹⁵² ¹⁸² ¹⁸⁷ In addition, potency of each antigen varies among the preparations.¹⁵² ¹⁸² ¹⁸⁷
Currently, there are 2 different Tdap preparations commercially available in the US (Adacel, Boostrix).¹⁹² ¹⁹³ Both Tdap preparations contain a lower content of diphtheria and pertussis antigens than that contained in DTaP.¹⁹² ¹⁹³ The tetanus antigen content is equivalent in both Tdap preparations, but the diphtheria and pertussis antigen content in Adacel is different than that in Boostrix.¹⁹² ¹⁹³
DTaP also available as a fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV; Kinrix), a fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix), a kit that provides a combination vaccine containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens (DTaP-IPV/Hib; Pentacel), and a kit that provides a combination vaccine containing diphtheria, tetanus, pertussis, and Hib antigens.¹⁰⁹ ¹⁶⁴ ²²³ ²²⁴
TDaP and Tdap stimulate active immunity to diphtheria and tetanus by inducing production of specific neutralizing antitoxin antibodies.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ The acellular pertussis vaccine component induces production of specific anti-pertussis antibodies, but the mechanism of protection against the disease has not been fully determined.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³
A complete primary immunization series with the age-appropriate preparation is needed to induce production of antitoxin antibody levels that provide protection.²⁰⁵
The diphtheria toxoid component provides protection only against the exotoxin elucidated by C. diphtheriae.¹⁹² ¹⁹³ Immunization does not prevent or eliminate colonization or carriage of C. diphtheriae in pharynx, nose, or skin.¹¹¹ ¹⁹²
Protective levels of diphtheria antitoxin (defined as ≥0.1 international units/mL)¹³⁴ ¹⁹⁵ ¹⁹⁶ ¹⁹⁸ ²⁰⁵ are attained in >95% of individuals after the primary vaccination series.¹⁹⁸ Antitoxin levels may persist for ≥10 years.¹⁹² However, levels decrease over time and are below optimal levels in many individuals 10 years after the last dose.¹⁹⁸
Protective levels of tetanus antitoxin (defined as ≥0.1 international units/mL using enzyme-linked immunoabsorbant assay [ELISA])¹⁹⁵ ¹⁹⁶ ²⁰⁵ are attained in almost 100% of individuals after the primary vaccination series.¹⁹⁸ Antitoxin levels may persist for ≥10 years and some individuals may be protected for life.¹¹¹ However, levels decrease over time and most individuals have levels that are suboptimal 10 years after the last dose.¹⁹⁸
There is no accepted serologic or laboratory correlation of protection against pertussis.¹⁸² ¹⁹⁵ ¹⁹⁶ Children who receive 3 doses of a preparation containing pertussis vaccine during infancy may be protected against pertussis until 6 years of age.¹⁸² There is evidence that administration of a dose of Tdap in adults results in a booster response to the pertussis antigens contained in the preparation.¹⁹³ ¹⁹⁵ ¹⁹⁶ ²⁰⁵

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 ).¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²⁰² ²²⁶
Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination against diphtheria, tetanus, and pertussis.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³
Importance of receiving the complete primary immunization series and recommended booster doses to ensure highest level of protection, unless contraindicated.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³
Advise patient that the vaccines may not provide protection in all vaccinees.¹⁵² ¹⁸⁷ ¹⁹² ¹⁹³
Importance of informing clinicians if child had a seizure or collapsed after a dose of DTaP, cried nonstop for ≥3 hours after a dose of DTaP, or had a fever >40.5°C or any unusual behavior after a dose of DTaP.²⁰²
Importance of contacting clinicians if a serious allergic reaction (e.g., difficulty breathing, hoarseness, wheezing, hives, paleness, weakness, fast heartbeat, dizziness) occurs following a dose.²⁰²
Clinicians or individuals can report any adverse reactions that occur following vaccination to Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ ²⁰²
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁵² ¹⁹² ¹⁹³
Importance of informing patients of other important precautionary information.¹⁵² ¹⁸² ¹⁸⁷ ¹⁹² ¹⁹³ (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 and Acellular Pertussis Vaccine Adsorbed (DTaP)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use	Diphtheria Toxoid 6.7 Lf units, Tetanus Toxoid 5 Lf units, and Acellular Pertussis Vaccine 46.8 mcg (of pertussis antigens) per 0.5 mL	Tripedia	Sanofi Pasteur
		Diphtheria Toxoid 15 Lf units, Tetanus Toxoid 5 Lf units, and Acellular Pertussis Vaccine 23 mcg (of pertussis antigens) per 0.5 mL	Daptacel	Sanofi Pasteur
		Diphtheria Toxoid 25 Lf units, Tetanus Toxoid 10 Lf units, and Acellular Pertussis Vaccine 58 mcg (of pertussis antigens) per 0.5 mL	Infanrix	GlaxoSmithKline

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use	Tetanus Toxoid 5 Lf units, Diphtheria Toxoid 2 Lf units, and Acellular Pertussis Vaccine 15.5 mcg (of pertussis antigens) per 0.5 mL	Adacel	Sanofi Pasteur
		Tetanus Toxoid 5 Lf units, Diphtheria Toxoid 2.5 Lf units, and Acellular Pertussis Vaccine 18.5 mcg (of pertussis antigens) per 0.5 mL	Boostrix	GlaxoSmithKline

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine (DTaP-IPV)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IM use	Diphtheria Toxoid 25 Lf units, Tetanus Toxoid 10 Lf units, Acellular Pertussis Vaccine 58 mcg (of pertussis antigen) and Poliovirus Type 1 40 DU, Poliovirus Type 2 8 DU, and Poliovirus Type 3 32 DU per 0.5 mL	Kinrix	GlaxoSmithKline

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (DTaP-HepB-IPV)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use	Diphtheria Toxoid 25 Lf units, Tetanus Toxoid 10 Lf units, Acellular Pertussis Vaccine 58 mcg (of pertussis antigen), Hepatitis B Surface Antigen 10 mcg, Poliovirus Type 1 40 DU, Poliovirus Type 2 8 DU, and Poliovirus Type 3 32 DU per 0.5 mL	Pediarix	GlaxoSmithKline

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (DTaP-IPV/Hib)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Kit, for IM use	Injection, for IM use, Diphtheria Toxoid 15 Lf units, Tetanus Toxoid 5 Lf units, Acellular Pertussis Vaccine 48 mcg (of pertussis antigen), Poliovirus Type 1 40 DU, Poliovirus Type 2 8 DU, and Poliovirus Type 3 32 DU per 0.5 mL For injectable suspension, for IM use, Haemophilus b Polysaccharide 10 mcg, Tetanus Toxoid 24 mcg per 0.5 mL, ActHIB	Pentacel	Sanofi Pasteur

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) Combination (DTaP/Hib)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Kit, for IM use	For injectable suspension, for IM use, Haemophilus b Capsular Polysaccharide 10 mcg and Tetanus Toxoid 24 mcg per 0.5 mL, ActHIB Injection, for IM use, Diphtheria Toxoid 6.7 Lf units/0.5 mL, Tetanus Toxoid 5 Lf units/0.5 mL, and Acellular Pertussis 46.8 mcg (of pertussis antigen) per 0.5 mL, Tripedia,	TriHIBit	Sanofi Pasteur

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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