Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

Drug class: Antineoplastic Agents

Usage of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

Prevention of Diphtheria, Tetanus, and Pertussis

DTaP (Daptacel, Infanrix): Prevention of diphtheria, tetanus, and pertussis in infants and children 6 weeks through 6 years of age.

Tdap: Labeled by FDA for booster immunization against diphtheria, tetanus, and pertussis in adults and adolescents 10 through 64 years of age (Adacel) or adults and adolescents ≥10 years of age (Boostrix). Also recommended for use in children 7 through 10 years of age† [off-label].

Diphtheria is caused by toxigenic strains of Corynebacterium diphtheriae or, rarely, C. ulcerans. Overall case-fatality rate is 5–10%; higher death rates (up to 20%) among individuals <5 years of age and >40 years of age. Diphtheria uncommon in US, but C. diphtheriae continues to circulate in US areas where the disease previously was endemic. Reported worldwide, particularly in tropical countries; endemic in many countries in Asia, the South Pacific, the Middle East, and Eastern Europe and in Haiti and Dominican Republic. Consult CDC Travelers' Health website ([Web]) for information regarding where diphtheria is endemic. During the 1920s (before widespread immunization against diphtheria was initiated), there were approximately 100,000–200,000 cases of diphtheria and 13,000–15,000 diphtheria-related deaths each year in US. Most diphtheria cases occur in individuals unvaccinated or incompletely vaccinated against diphtheria.

Tetanus is a potentially fatal disease caused by a neurotoxic exotoxin (tetanospasmin) produced by Clostridium tetani. C. tetani spores are ubiquitous in the environment worldwide; found in soil and in intestinal tracts of humans and animals (e.g., horses, sheep, cattle, dogs, cats, rats, guinea pigs, chickens). The spores can contaminate open wounds, especially puncture wounds or those with devitalized tissue; anaerobic wound conditions allow spores to germinate and produce exotoxins that disseminate through blood and lymphatic system. Neonatal tetanus (tetanus neonatorum) occurs in infants born under nonsterile conditions to inadequately vaccinated women; infection usually involves a contaminated umbilical stump and occurs because infant does not have passively acquired maternal antibodies against tetanus. Obstetric tetanus occurs within 6 weeks after delivery or termination of pregnancy because of contaminated wounds or abrasions or unclean deliveries or abortions. Generalized tetanus is characterized by rigidity and convulsive muscle spasms that usually involve the jaw (lockjaw) and neck and then become generalized. Tetanus occurs worldwide; reported most frequently in densely populated regions in hot, damp climates with soil rich in organic matter. Marked decrease in mortality from tetanus occurred in US from the early 1900s to the late 1940s when immunization against tetanus became part of routine childhood immunization. Average of 29 cases reported each year in US from 2001 through 2008 (case fatality rate 13%). Most US cases occur following an acute wound, usually a puncture or contaminated, infected, or devitalized wound. Almost all reported cases occur in individuals unvaccinated or inadequately vaccinated against the disease.

Pertussis (whooping cough) is an acute respiratory tract infection caused by Bordetella pertussis. Risk for severe pertussis and death highest among infants <1 year of age (especially those younger than 6 months of age). More than 1 million pertussis cases reported in US from 1940 through 1945 (average of 175,000 cases per year); incidence gradually declined in US after introduction of pertussis vaccine. Although average number of cases reported per year in US during 1980–1990 was 2900, pertussis incidence has been gradually increasing since early 1980s. During 2010, 27,550 pertussis cases and 27 pertussis-related deaths reported in US. B. pertussis infection in adults and adolescents may be asymptomatic or range from mild to severe. Adults and older siblings (including adolescents) with asymptomatic or mild pertussis are important sources of pertussis in unvaccinated or incompletely vaccinated infants and young children.

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine primary and booster immunization against diphtheria, tetanus, and pertussis in all individuals ≥6 weeks of age.

Combination preparation containing antigens for all 3 diseases (DTaP) preferred preparation for primary and booster immunization against these diseases in infants and children 6 weeks through 6 years of age, unless a component is contraindicated or should not be used.

ACIP, AAP, and others recommend that all adolescents who received primary immunization with DTaP, DTP (not commercially available in US), diphtheria and tetanus toxoids adsorbed (DT), or tetanus and diphtheria toxoids adsorbed (Td) receive a routine booster dose of Tdap (instead of Td) at 11 through 18 years of age (preferably at 11–12 years of age). If Tdap is unavailable or was administered previously, use Td for this adolescent booster dose.

Td usually preparation of choice for primary and booster immunization against diphtheria and tetanus in individuals ≥7 years of age. However, to reduce morbidity associated with pertussis, ACIP, AAP, and others recommend that a single dose of Tdap be used in place of a required primary or booster dose of Td in all adults, adolescents, and children 7 through 10 years of age† [off-label] who have not previously received Tdap, unless pertussis antigens contraindicated or should not be used. Use Td for all subsequent primary or booster doses.

ACIP recommends that all adults ≥65 years of age or older who have not previously received a dose of Tdap receive a single dose of Tdap, regardless of interval since last dose of vaccine containing tetanus or diphtheria toxoids. Use Td for all subsequent booster doses.

To ensure protection against pertussis, ACIP and others recommend that pregnant women receive a single dose of Tdap during each pregnancy (optimally between 27 and 36 weeks of gestation), regardless of prior vaccination history. (See Preexposure Vaccination Against Tetanus, Diphtheria, and Pertussis in High-risk Groups under Uses.)

DTaP-IPV (Kinrix): Can be used in children 4 through 6 years of age to provide fifth dose of DTaP vaccination series and fourth dose of IPV vaccination series in those receiving primary immunization with Infanrix (DTaP) and/or Pediarix (DTaP-HepB-IPV) when there are no contraindications to any of the individual components.

DTaP-IPV (Quadracel): Can be used in children 4 through 6 years of age to provide fifth dose of DTaP vaccination series and fourth or fifth dose of IPV vaccination series in those receiving primary immunization with Pentacel (DTaP-IPV/Hib) and/or Daptacel (DTaP).

DTaP-HepB-IPV (Pediarix): Can be used as 3-dose primary series in infants and children 6 weeks through 6 years of age born to HBsAg-negative women when doses of DTaP, HepB, and IPV are indicated and there are no contraindications to any of the individual components. ACIP states also may be used to complete HBV vaccination series in infants 6 months through 6 years of age born to HBsAg-positive women† [off-label]. Should not be used for initial HepB dose indicated in neonates. For prevention of diphtheria, tetanus, and pertussis in infants and children 6 weeks through 6 years of age, may be used for initial 3 doses in DTaP series. Also may be used to complete first 3 doses of DTaP series in children who received 1 or 2 doses of Infanrix DTaP; data not available regarding safety and efficacy of Pediarix used following ≥1 dose of DTaP vaccine from a different manufacturer. Children who receive 3-dose series of Pediarix should complete DTaP and IPV series according to recommended childhood immunization schedule. To complete DTaP series, manufacturer recommends use of Infanrix for fourth dose of DTaP and either Infanrix DTaP or DTaP-IPV (Kinrix) for fifth dose of DTaP (these vaccines contain same pertussis antigens as Pediarix).

DTaP-IPV/Hib (Pentacel): Can be used as 4-dose series 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. To complete DTaP series, children who receive 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 fifth dose of DTaP. Pentacel also may be used in infants and children 6 weeks through 4 years of age who received ≥1 doses of Daptacel DTaP. Data not available on safety and immunogenicity of mixed sequences of Pentacel and Daptacel for successive doses in DTaP series or mixed sequences of Pentacel and DTaP from other manufacturers.

Combined active immunization with a preparation containing tetanus toxoid adsorbed (Td, DT, DTaP, Tdap) and passive immunization with tetanus immune globulin (TIG) is used for postexposure prophylaxis in individuals with tetanus-prone wounds who are inadequately immunized against tetanus or whose tetanus immunization history is uncertain. (See Postexposure Prophylaxis of Tetanus under Uses.)

DTaP and Tdap not indicated for treatment of diphtheria, tetanus, or pertussis.

Because diphtheria and tetanus infections may not confer immunity against the diseases, initiate or complete primary immunization against diphtheria and tetanus at time of recovery in any previously unvaccinated or incompletely vaccinated individual. Although pertussis is likely to confer short-term immunity against the disease, protection wanes over time (beginning as early as 5–7 years after infection); initiate or complete immunization against pertussis at time of recovery.

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

Pregnant women should be adequately immunized against tetanus, diphtheria, and pertussis; protection is conferred to infants through transplacental transfer of maternal antibody.

Ideally, complete primary immunization and administer appropriate booster doses prior to pregnancy. To ensure protection against tetanus (especially against maternal and neonatal tetanus), primary immunization or booster doses of Td can be given during second or third trimester of pregnancy (and before 36 weeks of gestation).

For previously unvaccinated or incompletely vaccinated pregnant women, ACIP and others recommend that a dose of Tdap be substituted for a required Td dose, preferably during third trimester (optimally between 27 and 36 weeks of gestation). In addition, to ensure protection against pertussis, these experts recommend give a dose of Tdap during each pregnancy, regardless of prior vaccination history. (See Pregnancy under Cautions.)

Infants <12 months of age are at increased risk for pertussis (too young to be fully protected by initial DTaP doses given in early infancy). To reduce likelihood of pertussis transmission to such infants, ACIP and AAP recommend 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. Give Tdap dose at least 2 weeks before close contact with infant, regardless of interval since last Td dose.

Health-care personnel should have documentation of age-appropriate primary immunization with a preparation containing diphtheria and tetanus toxoids and booster doses of Td every 10 years. A single dose of Tdap also recommended for all health-care personnel (regardless of age) if they have not previously received a dose.

For health-care personnel without documentation of primary immunization, give 3-dose vaccination series using Tdap for first dose and Td for subsequent primary and booster doses. For previously vaccinated health-care personnel who have not received Tdap, give a single dose of Tdap as soon as feasible, regardless of interval since last Td dose; use Td for subsequent booster doses.

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

Because tetanus, diphtheria, and pertussis occur worldwide, CDC recommends that travelers be adequately immunized against all 3 diseases before leaving US.

Adults, adolescents, and children 7 through 10 years of age who are unvaccinated or incompletely vaccinated should receive a single dose of Tdap followed by remaining recommended doses of Td according to usual age-appropriate catch-up vaccination schedule. Adults and adolescents ≥11 years of age who were previously vaccinated but have not received Tdap should receive a single dose of Tdap (instead of Td) for booster dose. When indicated to provide protection against pertussis before travel, Tdap may be administered regardless of interval since last Td dose.

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

Postexposure Prophylaxis of Diphtheria

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

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

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. Contacts who previously completed primary vaccination series should receive an immediate booster dose of age-appropriate preparation containing diphtheria toxoid adsorbed if it has been ≥5 years since last booster dose.

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

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.

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).

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. 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.

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).

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

A dose of Tdap preferred instead of a dose of Td in adults and adolescents ≥11 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. Use Td in individuals in this age group who previously received a dose of Tdap.

Td used in adults, adolescents, and children ≥7 years of age. For children 6 weeks through 6 years of age, DTaP usually indicated, but DT can be used if pertussis antigens contraindicated. Single-antigen tetanus toxoid adsorbed not commercially available in US.

If only 3 doses of tetanus toxoid fluid (no longer commercially available in US) have been received previously, give a fourth dose 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. 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 Management195196237

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.

ACIP and others recommend that a single dose of Tdap be used in place of a dose of Td for postexposure prophylaxis in individuals ≥11 years of age (including those ≥65 years of age) who have not previously received a dose of Tdap. Those who previously received Tdap should receive Td for postexposure prophylaxis.

Anti-infectives 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.

Postexposure Prophylaxis of Pertussis

Postexposure vaccination in household and other close contacts of an individual with pertussis.

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).

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. Those who received their third DTaP dose ≥6 months before the exposure should receive a fourth dose.

ACIP and AAP recommend a single dose of Tdap in all adults, adolescents, and children ≥7 years of age who have not previously received a dose and are 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); this includes children 7 through 10 years of age† [off-label] who did not complete DTaP vaccination series.

Relate drugs

How to use Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

Administration

IM Administration

DTaP (Daptacel, Infanrix): Administer by IM injection.

Tdap (Adacel, Boostrix): Administer by IM injection.

DTaP-IPV (Kinrix, Quadracel), DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel): Administer by IM injection.

Do not administer DTaP, Tdap, or combination vaccines containing DTaP and other antigens IV, intradermally, or sub-Q.

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

Depending on patient age, administer IM into anterolateral muscles of thigh or deltoid muscle. In infants and children 6 weeks through 2 years of age, anterolateral thigh is preferred; alternatively, deltoid muscle can be used in those 1 through 2 years of age if muscle mass is adequate. In adults, adolescents, and children ≥3 years of age, deltoid muscle preferred.

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

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements). Occurs most frequently in adolescents and young adults. Have procedures in place to avoid falling injury and restore cerebral perfusion following syncope. Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination. If syncope occurs, observe patient until symptoms resolve.

When passive immunization with TIG is indicated in addition to active immunization with a preparation containing tetanus toxoid adsorbed for postexposure prophylaxis of tetanus, DTaP or Tdap may be given simultaneously with TIG using different syringes and different injection sites. (See Postexposure Prophylaxis of Tetanus under Uses.)

May be given simultaneously with other age-appropriate vaccines. (See Interactions.)

When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine with a different syringe and at different injection sites. Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.

DTaP (Daptacel, Infanrix)

Do not mix with any other vaccine.

Shake vial or prefilled syringe well immediately prior to use. Should appear as a uniform, turbid, white suspension after shaking; discard if it contains particulate matter, is discolored, or cannot be resuspended.

Tdap (Adacel, Boostrix)

Do not mix with any other vaccine.

Shake vial or prefilled syringe well immediately prior to use. Should appear as a uniform, turbid, white suspension after shaking; discard if it contains particulate matter, is discolored, or cannot be resuspended.

DTaP-IPV (Kinrix)

Do not mix with any other vaccine.

Shake vial or prefilled syringe vigorously immediately prior to use. Should appear as a uniform, turbid, white suspension after shaking; discard if it contains particulate matter, is discolored, or cannot be resuspended.

DTaP-IPV (Quadracel)

Do not mix with any other vaccine.

Shake single-dose vial well immediately prior to use. Should appear as a uniform, white, cloudy suspension after shaking; discard if it contains particulate matter, is discolored, or cannot be resuspended.

DTaP-HepB-IPV (Pediarix)

Do not mix with any other vaccine.

Shake prefilled syringe vigorously immediately prior to use. Should appear as a uniform, turbid, white suspension after shaking; discard if it contains particulate matter, is discolored, or cannot be resuspended.

DTaP-IPV/Hib (Pentacel)

Commercially available as kit containing single-dose vials of fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV vaccine) and single-dose vials of lyophilized Hib vaccine (ActHIB).

Prior to administration, reconstitute single-dose vial of lyophilized ActHIB vaccine by adding entire contents of single-dose vial of DTaP-IPV vaccine according to manufacturer’s instructions to provide a combined preparation containing diphtheria, tetanus, pertussis, poliovirus, and Hib antigens. Gently swirl until a cloudy, uniform white to off-white (yellow tinge) suspension is obtained.

Administer immediately after reconstitution.

Do not mix any component of DTaP-IPV/Hib (Pentacel) with any other vaccine or solution.

Dosage

Dosing schedule (i.e., number of doses) and specific preparation for primary and/or booster immunization (i.e., DTaP, Tdap, combination vaccine containing DTaP) varies depending on age. Follow age-appropriate recommendations for specific preparation used.

Limited data available regarding interchangeability of different DTaP vaccines in primary or booster vaccination series. Although ACIP recommends that same DTaP preparation used for initial dose be used to complete primary and booster vaccination series whenever possible, any available age-appropriate DTaP vaccine should be used to complete the series if particular DTaP vaccine used previously is not known or not available.

To ensure optimal protection, give complete primary vaccination series and recommended booster doses. Interruptions resulting in an interval between doses longer than recommended should not interfere with final immunity achieved; there is no need to give additional doses or start vaccination series over.

Pediatric Patients

Prevention of Diphtheria, Tetanus, and Pertussis Infants and Children 6 Weeks Through 6 Years of Age (DTaP; Daptacel, Infanrix) IM

Each dose is 0.5 mL.

Primary immunization consists of a series of 3 primary doses and 1 or 2 booster doses.

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

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

If pertussis is prevalent in the community or preexposure immunization is required prior to travel, may initiate vaccination series as early as 6 weeks of age and use minimum interval of 4 weeks between first 3 doses.

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

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

Each dose is 0.5 mL.

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

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

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

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

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

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

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

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

Each dose is 0.5 mL.

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. ACIP states this fixed-combination vaccine also may be used to complete the HBV vaccination series in infants 6 weeks through 6 years of age or older born to HBsAg-positive women† [off-label].

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

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

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

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

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 vaccination series if doses of DTaP and HepB vaccine also are indicated and there are no contraindications to any of the individual components.

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 vaccination series if doses of IPV and DTaP also are indicated and there are no contraindications to any of the individual components. Do not use for the initial dose of HepB vaccine indicated in neonates. Although a 3-dose series of Pediarix may be used in infants who received a dose of HepB vaccine at or shortly after birth, manufacturer states data are limited regarding safety of the vaccine in such infants. Data not available to support use of a 3-dose series of Pediarix in those who previously received >1 dose of HepB vaccine.

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

Each dose is 0.5 mL.

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

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

Quadracel: Used to provide fifth dose of DTaP vaccination series and fourth or fifth dose of IPV vaccination series in children 4 through 6 years of age receiving primary immunization with Pentacel (DTaP-IPV/Hib) and/or Daptacel (DTaP).

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

Usual dose is 0.5 mL.

Although safety and efficacy for primary immunization not established, 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 contraindicated or should not be used.

ACIP and others state 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 1–2 months after Tdap and a second Td dose given 6–12 months after first Td dose. Alternatively, substitute Tdap for any 1 of the Td doses. Do not give these children a Tdap booster dose at 11 through 12 years of age.

Previously Unvaccinated Adolescents 11 through 18 Years of Age (Tdap; Adacel, Boostrix) IM

Usual dose is 0.5 mL.

Although safety and efficacy of Tdap for primary immunization not established, 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 contraindicated or should not be used.

ACIP and others state 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. Alternatively, substitute Tdap for any 1 of the 3 doses of Td.

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

Booster dose is 0.5 mL.

To maintain adequate immunity against diphtheria and tetanus, ACIP and others 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, Td) receive a booster dose of a preparation containing diphtheria and tetanus toxoids at 11 through 12 years of age, provided at least 5 years have elapsed since the last dose.

Because adolescents also at risk for pertussis, ACIP and others recommend Tdap (instead of Td) for adolescent booster at 11 through 18 years of age (preferably 11 through 12 years of age), unless already given or pertussis antigens contraindicated or should not be used. Give Tdap dose regardless of interval since last dose of diphtheria and tetanus toxoids.

Adolescents who have not previously received Tdap and who anticipate having close contact with an infant <12 months of age: Give Tdap dose at least 2 weeks before beginning close contact with the infant, regardless of interval since last dose of vaccine containing diphtheria and tetanus toxoids (e.g., Td).

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

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

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.

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

Postexposure Prophylaxis of Tetanus

Emergency dose of a preparation containing tetanus toxoid adsorbed may be indicated with or without a dose of TIG. (See Postexposure Prophylaxis of Tetanus under Uses.)

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

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

Emergency booster dose is 0.5 mL.

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

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

For most individuals, Td indicated for emergency booster doses. Use single dose of Tdap (instead of Td) in those who have not previously received Tdap. If Tdap not available or administered previously, use Td.

Postexposure Prophylaxis of Pertussis Infants and Children 6 Weeks Through 6 Years of Age (DTaP; Daptacel, Infanrix) IM

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. Give a fourth dose of DTaP to those who received their third DTaP dose ≥6 months before the exposure; give a fifth dose to those who received their fourth dose ≥3 years before the exposure.

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

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

Booster dose is 0.5 mL.

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 in those who have not previously received a dose.

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

Adults

Prevention of Diphtheria, Tetanus, and Pertussis Primary Immunization in Adults ≥19 Years of Age† (Tdap; Adacel, Boostrix) IM

Usual dose is 0.5 mL.

Although safety and efficacy of Tdap for primary immunization not established, ACIP and others recommend that primary immunization† against diphtheria and tetanus in previously unvaccinated or incompletely vaccinated adults ≥19 years of age include a single dose of Tdap, unless pertussis antigens contraindicated or should not be used.

Previously unvaccinated adults: ACIP and others state preferred primary immunization schedule is a single dose of Tdap followed by a dose of Td at least 4 weeks after Tdap and a second dose of Td 6–12 months after first Td dose. Alternatively, substitute Tdap for any 1 of the 3 doses of Td.

Booster Dose in Adults ≥19 Years of Age (Tdap; Adacel, Boostrix) IM

Booster dose is 0.5 mL.

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

Because adults may be at risk for pertussis, ACIP and others recommend a single dose of Tdap (instead of Td) when a booster dose is needed in adults ≥19 years of age (including those ≥65 years of age) who have not previously received Tdap, unless pertussis antigens contraindicated or should not be used. If indicated, give Tdap dose regardless of interval since last dose of vaccine containing diphtheria or tetanus toxoids (e.g., Td). Use Td for subsequent booster doses.

Adults ≥19 years of age who have not previously received Tdap and who have or anticipate having close contact with an infant <12 months of age: Give Tdap dose at least 2 weeks before beginning close contact with the infant, regardless of interval since last dose of vaccine containing diphtheria and tetanus toxoids (e.g., Td).

Adults ≥65 years of age who have not previously received Tdap: Although only Tdap (Boostrix) labeled by FDA for this age group, ACIP states either Tdap (Adacel) or Tdap (Boostrix) can be used.

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

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

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.

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

Postexposure Prophylaxis of Tetanus

Emergency dose of a preparation containing tetanus toxoid adsorbed may be indicated with or without a dose of TIG. (See Postexposure Prophylaxis of Tetanus under Uses.)

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

Adults ≥19 Years of Age (Tdap; Adacel, Boostrix) IM

Emergency booster dose is 0.5 mL.

Individuals who previously received <3 doses of a tetanus toxoid-containing preparation or whose vaccination status is unknown: Give emergency booster dose of age-appropriate preparation containing tetanus toxoid adsorbed as soon as possible if injury and possible exposure to tetanus occurs.

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

For most adults, Td indicated for emergency booster doses. Use single dose of Tdap (instead of Td) in adults ≥19 years of age (including those ≥65 years of age) who have not previously received Tdap. If Tdap not available or administered previously, use Td.

Postexposure Prophylaxis of Pertussis Adults 19 through 64 Years of Age (Tdap; Adacel, Boostrix) IM

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.

Used as an adjunct to anti-infective postexposure prophylaxis. (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.

Warnings

Contraindications

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

    • Warnings/Precautions

    Warnings

    Guillain-Barré Syndrome and Other Neurologic Disorders

    Guillain-Barré syndrome (GBS) reported as temporally associated with tetanus toxoid.

    A review by the Institute of Medicine (IOM) found evidence of a causal relationship between tetanus toxoid and brachial neuritis and GBS. 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.

    Risk of GBS may be increased in individuals with a history of GBS within 6 weeks after receiving a prior dose of any preparation containing tetanus toxoid. Some manufacturers state base decision to administer subsequent doses of DTaP, Tdap, or any vaccine containing tetanus toxoid in such patients on careful consideration of potential benefits and possible risks.

    ACIP states 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. ACIP does not consider brachial neuritis a precaution or contraindication for further doses.

    Manufacturers of Tdap (Adacel, Boostrix) state 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. Administration in such individuals may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.

    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: 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 occurring within 3 days.

    Some manufacturers state that administration of vaccines containing pertussis antigen should not be considered in individuals with progressive neurologic disorders until a treatment regimen has been established and the condition has stabilized. In those 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. Advise the patient and/or patient’s parent or guardian of the potential risks.

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

    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. 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.

    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).

    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 toxoids.

    Prior to injection of DTaP, Tdap, or combination vaccine containing DTaP, review patient’s history regarding possible sensitivity and any previous adverse reactions and take all precautions known for prevention of allergic or any other adverse effects. Have epinephrine and other appropriate agents and equipment available for immediate use in case an anaphylactic reaction occurs.

    If 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. If further doses are being considered (e.g., for tetanus postexposure prophylaxis), consider consultation with an allergist.

    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.

    Arthus-type Hypersensitivity Reactions

    Arthus-type hypersensitivity reactions to tetanus toxoid reported.

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

    Arthus reactions usually resolve without sequelae.

    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.

    Allergy to Neomycin or Other Anti-infectives

    DTaP-IPV (Kinrix): Contains trace amounts of neomycin (≤0.05 ng) and polymyxin B (≤0.01 ng). Manufacturer states the vaccine is contraindicated in individuals with severe hypersensitivity (e.g., anaphylaxis) to neomycin and/or polymyxin B.

    DTaP-IPV (Quadracel): Contains trace amounts of neomycin (<4 pg) and polymyxin B (<4 pg).

    DTaP-HepB-IPV (Pediarix): Contains trace amounts of neomycin (≤0.05 ng) and polymyxin B (≤0.01 ng). Manufacturer states the vaccine is contraindicated in individuals with severe hypersensitivity (e.g., anaphylaxis) to neomycin and/or polymyxin B.

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

    Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis. 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.

    Allergy to Certain Preservatives

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

    DTaP-IPV (Quadracel): Contains phenoxyethanol (0.6%) and residual formaldehyde (≤5 mcg) from the manufacturing process.

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

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

    Yeast Allergy

    DTaP-HepB-IPV (Pediarix): Manufacturing process for HepB vaccine component involves baker’s yeast (Saccharomyces cerevisiae) and final product contains yeast protein (≤5%). Manufacturer states the vaccine is contraindicated in individuals with severe hypersensitivity (e.g., anaphylaxis) to yeast.

    Latex Sensitivity

    Some components (i.e., tip caps) of single-dose prefilled syringes of DTaP (Infanrix), Tdap (Adacel, Boostrix), DTaP-IPV (Kinrix), and DTaP-HepB-IPV (Pediarix) may contain natural rubber latex. which may cause sensitivity reactions in susceptible individuals.

    ACIP states 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 benefits of vaccination outweigh risk of a potential allergic reaction. Contact-type allergy is the most common type of latex sensitivity.

    General Precautions

    Individuals with Altered Immunocompetence

    If administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy, consider possibility that immune response to the vaccine and efficacy may be reduced in these individuals. (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. However, immunization may be less effective in individuals with HIV infection than in immunocompetent individuals.

    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.

    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).

    Limitations of Vaccine Effectiveness

    May not protect all individuals from diphtheria, tetanus, and pertussis.

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

    Tdap (Adacel, Boostrix) labeled by FDA for booster immunization; safety and efficacy not established for primary immunization.

    Duration of Immunity

    Following primary immunization, duration of protection against diphtheria is approximately 10 years.

    Following primary immunization, duration of protection against tetanus is approximately 10 years. Although some individuals may be protected for life, antitoxin levels decrease over time and only approach minimal protective level in most individuals 10 years after last dose. 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).

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

    Pre- and Postvaccination Serologic Testing

    Routine prevaccination serologic testing not recommended.

    When postexposure prophylaxis against tetanus or preexposure vaccination in high-risk groups (e.g., travelers) is indicated in individuals with an unknown or uncertain history of vaccination, consider such individuals unvaccinated and give complete primary vaccination series.

    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. 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.

    Use of Fixed Combinations

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

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

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

    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.

    Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained. (See Storage under Stability.)

    Do not administer DTaP, Tdap, or combination vaccine containing DTaP that have been mishandled or have not been stored at the recommended temperature.

    If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.

    Specific Populations

    Pregnancy

    DTaP (Daptacel, Infanrix): Category C. Not indicated in adults, including pregnant women.

    Tdap (Adacel): Category C.

    Tdap (Boostrix): Category B.

    DTaP-IPV (Kinrix, Quadracel), DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel): Category C. Not indicated in adults, including pregnant women.

    Because of risks associated with diphtheria, tetanus, and pertussis, ACIP and AAP state that pregnancy not considered a contraindication for Tdap (Adacel, Boostrix).

    Ideally, complete primary immunization against tetanus and diphtheria prior to pregnancy.

    Although Td generally preferred preparation for primary immunization against diphtheria and tetanus during pregnancy, ACIP and others state that a dose of Tdap should be substituted for 1 of the required primary Td doses, preferably during third trimester (optimally between 27 and 36 weeks of gestation) in previously unvaccinated or incompletely vaccinated pregnant women. In addition, to ensure protection against pertussis, these experts recommend a dose of Tdap during each pregnancy, regardless of woman's prior vaccination history. To maximize maternal antibody response and passive antibody transfer to infant, optimal timing for Tdap dose is between 27 and 36 weeks of gestation.

    Pregnant women who were previously vaccinated but received most recent dose of a preparation containing tetanus and diphtheria toxoids ≥10 years ago should receive a booster dose of a preparation containing tetanus and diphtheria toxoid adsorbed during second or third trimester of pregnancy (and before 36 weeks of gestation). This dose is important if woman does not have sufficient tetanus immunity to protect against maternal and neonatal tetanus or if protection against diphtheria is needed (e.g., for travel to an area where diphtheria is endemic). Use Tdap (instead of Td) for the booster dose; preferably give Tdap during third trimester (optimally between 27 and 36 weeks gestation).

    If postexposure prophylaxis of tetanus indicated as part of wound management in a pregnant woman, follow usual recommendations regarding emergency booster doses. (See Postexposure Prophylaxis of Tetanus under Uses.) Give booster dose of Tdap (instead of Td).

    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).

    Lactation

    Tdap (Adacel, Boostrix): Not known whether the antigens distributed into milk. Manufacturers recommend caution in nursing women.

    ACIP states breast-feeding is not considered a contraindication for Tdap.

    Pediatric Use

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

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

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

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

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

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

    Geriatric Use

    DTaP (Daptacel, Infanrix): Not indicated in adults, including geriatric adults.

    Tdap (Adacel): Safety and efficacy not established in adults ≥65 years of age. Although not labeled by FDA for adults ≥65 years of age, ACIP states the vaccine can be used in this age group if it is the only available Tdap vaccine.

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

    DTaP-IPV (Kinrix, Quadracel), DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel): Not indicated in adults, including geriatric adults.

    Common Adverse Effects

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

    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.

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

    DTaP-IPV (Quadracel): Injection site reactions (pain, redness, increase in arm circumference, swelling), myalgia, malaise, headache.

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

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

    What other drugs will affect Diphtheria and Tetanus Toxoids 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. 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.

    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). 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).

    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 adsorbed

    DTaP or Tdap may be administered simultaneously using different syringes and different injection sites

    Hepatitis B (HepB) vaccine

    Concurrent administration of DTaP or Tdap and HepB vaccine does not result in reduced antibody responses to either vaccine

    DTaP or Tdap may be administered simultaneously with (using different syringes and injection sites) or at any time before or after HepB vaccine

    Hib vaccine

    Concurrent administration of DTaP and Hib vaccine does not result in reduced antibody responses to either vaccine

    DTaP or Tdap may be administered simultaneously with or at any time before or after Hib vaccine using different syringes and injection sites

    Human papillomavirus (HPV) vaccine

    4vHPV (Gardasil): Concurrent administration with Tdap (Adacel) and MCV4 (Menactra) at 3 different injection sites in adolescents 11 through 17 years of age did not interfere with antibody response to any of the vaccine antigens; increased incidence of swelling at the 4vHPV (Gardasil) injection site compared with administration of 4vHPV (Gardasil) alone

    9vHPV (Gardasil 9): Concurrent administration with Tdap (Adacel) and MCV4 (Menactra) at 3 different injection sites in adolescents 11 through 15 years of age did not interfere with antibody response to any of the vaccine antigens; increased rate of swelling at the 9vHPV (Gardasil 9) injection site compared with administration of 9vHPV (Gardasil 9) alone

    HPV vaccine: May be administered simultaneously with Tdap (Adacel) using different syringes and injection sites

    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 globulin

    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 syringe

    Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)

    Individuals receiving immunosuppressive agents may have a diminished immunologic response to DTaP or Tdap

    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 dosages

    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 required

    Influenza vaccine

    Parenteral inactivated influenza vaccine (Fluzone): Concurrent administration with Tdap (Adacel) did not result in reduced antibody responses to tetanus, diphtheria, or influenza antigens; lower antibody response to pertactin, but not the other pertussis antigens

    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; not known if efficacy is affected by the reduced response to these pertussis antigens

    DTaP or Tdap may be administered simultaneously with (using different syringes and injection sites) or at any time before or after parenteral inactivated influenza vaccine

    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 MMR

    Meningococcal vaccine

    MCV4 (Menactra): Concurrent administration of Tdap (Adacel), 4vHPV (Gardasil), and MCV4 (Menactra) at 3 different injection sites in boys and girls 10 through 17 years of age or concurrent administration of Tdap (Adacel), 9vHPV (Gardasil 9), and MCV4 (Menactra) at 3 different injection sites in adolescents 11 through 15 years of age did not interfere with antibody response to any of the antigens; increased incidence of some adverse reactions with concurrent administration (see Human Papillomavirus [HPV] Vaccine entry in this table)

    MCV4 (Menactra): Concurrent administration with Tdap (Boostrix) in adolescents 11 through 18 years of age did not affect immune response to diphtheria, tetanus, and meningococcal antigens, but immune response to pertactin pertussis antigen was lower compared with administration 1 month apart; not known if efficacy is affected by reduced response to pertactin

    MCV4 (Menveo): Concurrent administration with Tdap (Boostrix) and 4vHPV (Gardasil) in adolescents 11 through 18 years of age did not interfere with immune response to the meningococcal antigens; although clinical importance unclear, antibody response to some pertussis antigens was decreased; systemic adverse reactions were more frequent in those receiving MCV4 with Tdap and 4vHPV compared with those receiving MCV4 alone

    MCV4 (Menactra): May be administered concurrently with (using different syringes and different injection sites) or any time before or after Tdap; AAP states if the vaccines not given concurrently, administer at least 1 month apart

    Pneumococcal vaccine

    PPSV23 (Pneumovax 23): Does not reduce antibody response to DTaP and does not increase severity of adverse reactions

    PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with DTaP (using different syringes and different injection sites)

    Poliovirus vaccine

    Although data regarding the immunologic response are not available, IPV has been safely administered concurrently (at a separate site) with Infanrix

    DTaP may be administered concurrently with IPV

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