Diphtheria and tetanus toxoids and acellular pertussis vaccines (DTaP [age <7 years] and Tdap [age ≥7 years]): Drug information

(For additional information see "Diphtheria and tetanus toxoids and acellular pertussis vaccines (DTaP [age <7 years] and Tdap [age ≥7 years]): Patient drug information" and see "Diphtheria and tetanus toxoids and acellular pertussis vaccines (DTaP [age <7 years] and Tdap [age ≥7 years]): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Adacel;
Boostrix;
Daptacel;
Infanrix

Brand Names: Canada

Adacel;
Boostrix

Pharmacologic Category

Vaccine;
Vaccine, Inactivated (Bacterial)

Dosing: Adult

Note: Tdap vaccines (Adacel, Boostrix) are used in patients ≥7 years of age; DTaP vaccines (Daptacel, Infanrix) are for use in pediatric patients 6 weeks to <7 years of age. Tdap vaccines contain less diphtheria toxoid and pertussis antigens per dose than DTaP vaccines; the vaccines are not interchangeable. Tdap can be administered regardless of the interval between the last tetanus or diphtheria toxoid-containing vaccine. Tdap or Td can be used for most adults when tetanus vaccination is recommended (Ref).

Catch-up immunization

Catch-up immunization (Ref): Note: Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).

Tdap (Adacel, Boostrix): IM: 0.5 mL as a 3-dose series at 0, ≥4 weeks, and 6 to 12 months later. At least 1 dose should be Tdap; preferably dose 1, with either Td or Tdap appropriate for doses 2 and 3. Note: For persons who have never received a pertussis-, tetanus-, or diphtheria-containing vaccine.

Booster immunization

Booster immunization (Ref): Tdap (Adacel, Boostrix): IM: 0.5 mL per dose. Any patient who has not previously received a dose of Tdap should receive a dose of Tdap, regardless of interval since last tetanus- or diphtheria-containing vaccine. A booster dose of either Td or Tdap should be administered every 10 years throughout life.

Immunization during pregnancy for infant protection against pertussis

Immunization during pregnancy for infant protection against pertussis : Tdap (Adacel, Boostrix): IM: 0.5 mL per dose during the third trimester of pregnancy. Pregnant persons should receive a single dose of Tdap during each pregnancy (preferably during the early part of 27 to 36 weeks’ gestation) regardless of previous vaccination status to prevent pertussis in infants <2 months of age (Ref).

Tetanus prophylaxis in wound management

Tetanus prophylaxis in wound management (Ref): IM: Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated and the immunization status of the patient, including time from last tetanus-containing vaccine. Wound management includes use of tetanus toxoid and/or tetanus immune globulin (TIG) where appropriate, wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor. See table.

**Tetanus Prophylaxis in Wound Management**
History of Tetanus Immunization Doses	Clean, Minor Wounds		All Other Wounds^a
History of Tetanus Immunization Doses	Tetanus Toxoid^b	TIG	Tetanus Toxoid^b	TIG
^aSuch as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite.
^bTetanus toxoid in this chart refers to a tetanus toxoid-containing vaccine. For children <7 years of age, DTaP (DT, if pertussis vaccine contraindicated) is recommended. For children 7 to 10 years of age who are not fully immunized against pertussis, diphtheria, or tetanus, Tdap should be used (followed by completion of catch-up series). Tdap is preferred in patients ≥11 years of age if the patient has not previously been vaccinated with Tdap, if Tdap history is unknown, or if the patient is pregnant. In patients who have previously been vaccinated with Tdap, either Td or Tdap may be used.
^cYes, if ≥10 years since last dose.
^dYes, if ≥5 years since last dose.
^eFor patients with HIV infection or severe immunodeficiency with contaminated wounds, TIG should be administered, regardless of history of tetanus immunization.
Abbreviations: DT = Diphtheria and tetanus toxoids (formulation for <7 years of age); DTaP = Diphtheria and tetanus toxoids, and acellular pertussis (formulation for <7 years of age; Daptacel, Infanrix); Td = Diphtheria and tetanus toxoids (formulation for ≥7 years of age; TDVax, Tenivac); Tdap = Diphtheria and tetanus Toxoids, and acellular pertussis (Adacel or Boostrix [formulations for ≥7 years of age]); TIG = Tetanus immune globulin.
Uncertain or <3 doses	Yes	No	Yes	Yes
≥3 doses	No^c	No	No^d	No^e

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Booster immunization: IM: Adults ≥65 years of age:

The Advisory Committee on Immunization Practices (ACIP) recommendations: Refer to adult dosing. In adults ≥65 years of age Boostrix should be used if feasible; however, ACIP has concluded that either Tdap vaccine (Boostrix or Adacel) may be used (Ref).

Manufacturer's labeling: Boostrix: 0.5 mL as a single dose, administered ≥5 years after last dose of tetanus toxoid, diphtheria toxoid, and/or pertussis-containing vaccine if received.

Wound management: IM: Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Diphtheria and tetanus toxoids and acellular pertussis vaccines (DTaP [age <7 years] and Tdap [age ≥7 years]): Pediatric drug information")

Note: In the United States, DTaP vaccines (Daptacel, Infanrix) are for use in pediatric patients 6 weeks to <7 years of age; Tdap vaccines (Adacel, Boostrix) are used in patients ≥7 years of age; in Canada, Adacel and Boostrix are approved for patients ≥4 years of age. Tdap vaccines contain less diphtheria toxoid and pertussis antigens per dose than DTaP vaccines; the vaccines are not interchangeable. Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).

Primary immunization

Primary immunization: CDC (ACIP) Recommendations:

Infants and Children 6 weeks to <7 years: Note: Whenever feasible, the same manufacturer should be used for all doses of the vaccination series; however, vaccination should not be deferred if a specific brand is not known or is not available (Ref). See manufacturer labeling for specific interchangeability details. Preterm infants should be vaccinated according to their chronological age from birth.

DTaP (Daptacel, Infanrix): IM: 0.5 mL per dose for a total of 5 doses administered as follows (Ref):

Three doses (primary series): Usually given at 2, 4, and 6 months of age; may be given as early as 6 weeks of age and repeated every 4 to 8 weeks.

Fourth dose (first booster): Given at ~15 to 18 months of age but at least 6 months after third dose. The fourth dose may be given as early as 12 months of age. Note : If the fourth dose is inadvertently administered early (≥4 months from the third dose instead of 6 months) and the child is ≥1 year of age, then the fourth dose does not need repeated.

Fifth dose (second booster): Given at 4 to 6 years of age, prior to starting school or kindergarten; if the fourth dose is given at ≥4 years of age, the fifth dose may be omitted.

Catch-up immunization

Catch-up immunization: CDC (ACIP) Recommendations (Ref): Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number.

Infants and Children who start primary immunization series ≥4 months of age through 6 years (prior to 7th birthday): DTaP (Daptacel, Infanrix): IM: 0.5 mL per dose for a total of 4 to 5 doses depending on number of previous doses and age.

Children ≥7 years and Adolescents not fully vaccinated against pertussis, or whose vaccination status is not known: Tdap (Adacel, Boostrix): IM: 0.5 mL as first dose of the catch-up series; if additional doses are needed per catch-up schedule, either Tdap or Td may be used (Ref).

Note: If DTaP was inadvertently given as catch-up dose to a undervaccinated child 7 to 9 years of age, it should count as a Tdap dose in the catch-up series (Ref).

Booster immunization

Booster immunization: Note: Tdap can be administered regardless of the interval between the last acellular pertussis, tetanus, or diphtheria toxoid-containing vaccine.

Children ≥10 years and Adolescents: Tdap (Adacel, Boostrix): IM: 0.5 mL as a single routine booster dose at age 11 or 12 years in children who have completed a childhood vaccination series, followed by additional booster doses of either Td or Tdap every 10 years (Ref).

Note: If Tdap was given either inadvertently or used as part of catch-up dosing at 7 to 9 years of age, it should not be counted as the adolescent booster dose and the child should still receive a Tdap booster between ages 11 to 12 years. At age ≥10 years, Tdap doses given as part of catch-up series or DTaP doses given inadvertently may count as the adolescent Tdap dose (Ref).

Canadian labeling: Children ≥4 years and Adolescents: Tdap (Adacel, Boostrix): IM: 0.5 mL as a single dose (Ref); routinely recommended at 14 to 16 years of age (Ref).

Tetanus prophylaxis in wound management

Tetanus prophylaxis in wound management (Ref):

Infants ≥6 weeks and Children <7 years: DTaP (Daptacel, Infanrix): Administration of dose should be determined based on patient's current immunization status with the primary immunization or catch-up dosing series to ensure appropriate minimum dosing intervals maintained; should count as the next dose in the series.

Children ≥7 years and Adolescents: Tdap (Adacel, Boostrix): IM: 0.5 mL as a single dose.

Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated and the immunization status of the patient, including time from last tetanus-containing vaccine. Wound management includes use of tetanus toxoid and/or tetanus immune globulin (TIG) where indicated, wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow-up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor. See table.

**Tetanus Prophylaxis Wound Management**
History of Tetanus Immunization (Doses)	Clean, Minor Wounds		All Other Wounds^a
^aSuch as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite.
^bTetanus toxoid in this chart refers to a tetanus toxoid-containing vaccine. For children <7 years of age, DTaP (DT, if pertussis vaccine contraindicated) is recommended. For children 7 to 10 years who are not fully immunized against pertussis, diphtheria, or tetanus, Tdap should be used (followed by completion of catch-up series). Tdap is preferred in patients ≥11 years of age if the patient has not previously been vaccinated with Tdap, if Tdap history is unknown, or if the patient is pregnant. In patients who have previously been vaccinated with Tdap, either Td or Tdap may be used.
^cYes, if ≥10 years since last dose.
^dYes, if ≥ 5 years since last dose.
^eFor patients with HIV infection or severe immunodeficiency with contaminated wounds, TIG should be administered, regardless of history of tetanus immunization.
Abbreviations: DT = Diphtheria and Tetanus Toxoids (formulation for age <7 years); DTaP = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (formulation for age <7 years; Daptacel, Infanrix); Td = Diphtheria and Tetanus Toxoids (formulation for age ≥7 years; TDVax, Tenivac); Tdap = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (Adacel or Boostrix [formulations for age ≥7 years]); TIG = Tetanus Immune Globulin
	Tetanus toxoid^b	TIG	Tetanus toxoid^b	TIG
Uncertain or <3 doses	Yes	No	Yes	Yes
3 or more doses	No^c	No	No^d	No^e

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

DTaP (ages <7 years). Adverse reactions may be reported with use of other concomitant vaccines. Adverse reactions occurred with infants and children unless otherwise specified.

>10%:

Gastrointestinal: Anorexia (8% to 28%)

Local: Erythema at injection site (≤48%), pain at injection site (infants: 30% to 32%; children: 45% to 53%), swelling at injection site (≤33%), swelling of injected limb (children: ≤38%; increased mid-thigh circumference: children: 33%), tenderness at injection site (infants: 8% to 49%; children: 50%)

Nervous system: Drowsiness (infants: 19% to 54%; children: 18% to 36%), excessive crying (1% to 59%), fussiness in an infant or toddler (infants: ≤76%; children: ≤54%), irritability (including fretfulness: infants: ≤76%; children: ≤54%), lethargy (25% to 51%)

Miscellaneous: Fever (infants: ≤30%; children: ≤15%)

1% to 10%: Gastrointestinal: Vomiting (infants: 4% to 7%)

<1%: Nervous system: Seizure

Tdap (>10 years). Adverse reactions may be reported with use of other concomitant vaccines. Adverse reactions occurred with adolescents and adults unless otherwise specified.

>10%:

Gastrointestinal: Gastrointestinal signs and symptoms (adolescents: 26%; adults: 8% to 16%), nausea (9% to 13%)

Local: Erythema at injection site (4% to 38%; older adults: 11%), pain at injection site (38% to 87%; older adults: 22%), swelling at injection site (5% to 25%; older adults: 8%), swelling of injected limb (adolescents: 1% to 28%)

Nervous system: Body pain (≤30%), chills (8% to 15%), fatigue (16% to 37%; older adults: 13%), headache (15% to 44%; older adults: 12%), malaise (adults: 33%), myasthenia (≤30%)

Neuromuscular & skeletal: Arthralgia (≤11%), joint swelling (≤11%), myalgia (25% to 58%)

Miscellaneous: Fever (≤14%; older adults: ≤2%)

1% to 10%:

Dermatologic: Skin rash (2% to 3%)

Gastrointestinal: Diarrhea (10%), vomiting (3% to 5%)

Hematologic & oncologic: Benign lymph node hyperplasia (7%)

Nervous system: Shivering (4%)

Postmarketing:

Cardiovascular: Myocarditis, syncope

Dermatologic: Cellulitis, erythema of skin, erythematous rash, macular eruption, maculopapular rash, pruritus, urticaria

Hematologic & oncologic: Henoch-Schönlein purpura, lymphadenitis, lymphadenopathy, thrombocytopenia

Hypersensitivity: Arthus reaction, hypersensitivity reaction (including anaphylaxis, angioedema, nonimmune anaphylaxis)

Infection: Sterile abscess

Local: Abscess at injection site, bruising at injection site, cellulitis at injection site, induration at injection site, inflammation at injection site, injection-site nodule, injection-site pruritus, rash at injection site, residual mass at injection site, warm sensation at injection site

Nervous system: Encephalitis, encephalopathy, facial nerve paralysis, febrile seizure, focal seizure, Guillain-Barre syndrome, hypoesthesia, hypotonia, loss of consciousness, neuritis (brachial), paresthesia, screaming, tonic-clonic seizure

Neuromuscular & skeletal: Back pain, joint swelling (injected limb), muscle spasm, myelitis, myositis

Respiratory: Bronchitis, cough, cyanosis, respiratory tract infection

Miscellaneous: Hypotonic/hyporesponsive episode

Contraindications

Hypersensitivity to diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or any component of the formulation; progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy (postpone until condition stabilized) (Infanrix only); encephalopathy occurring within 7 days of a previous dose of a pertussis-containing vaccine and not attributable to another cause; administration to children and adults ≥7 years of age (Daptacel only).

Canadian labeling: Additional contraindications (not in US labeling; Boostrix only): Transient thrombocytopenia or neurological complications following a previous dose of diphtheria and/or tetanus vaccine.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/Hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).

• Arthus-type hypersensitivity: Patients with a history of severe local reaction (Arthus-type) following a previous diphtheria toxoid or tetanus toxoid-containing vaccine dose should not be given further routine or emergency doses of Td unless ≥10 years since most recent dose, even if using for wound management with wounds that are not clean or minor; these patients generally have high serum antitoxin levels (CDC/ACIP [Liang 2018]).

• Reactions from previous dose: Carefully consider use in patients with history of any of the following effects from previous administration of any pertussis-containing vaccine: Fever ≥105°F (40.5°C) within 48 hours of unknown cause; seizures with or without fever occurring within 3 days; persistent, inconsolable crying episodes lasting ≥3 hours and occurring within 48 hours; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours (CDC/ACIP [Liang 2018]).

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]).

• Brachial neuritis: Has occurred following tetanus toxoid-containing vaccines; use with caution (CDC/ACIP [Liang 2018]).

• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid-containing vaccine (CDC/ACIP [Liang 2018]).

• Neurologic disorders: Use with caution in patients with progressive neurologic disease including infantile spasms, uncontrolled seizure, or a progressive encephalopathy, or conditions predisposing to seizures; the Advisory Committee on Immunization Practices (ACIP) guidelines recommend deferring immunization until health status can be assessed and condition stabilized (CDC/ACIP [Liang 2018]).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration; vaccinations should be administered prior to initiation of anticoagulation therapy if possible (ACIP [Kroger 2023]).

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual component. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2023]). Administration of Menactra (meningococcal MenACWY-D conjugate vaccine) one month after Daptacel has been shown to have reduced meningococcal antibody responses in children 4 to 6 years; these vaccines should be administered simultaneously or Menactra should be administered prior to Daptacel.

Special populations:

• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high dose corticosteroids]); if appropriate, may have a reduced response to vaccination. May be used in patients with HIV infection. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).

• Pediatric: Apnea has been reported following IM vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (AAP [Saari 2003]; ACIP [Kroger 2023]).

Dosage form specific issues:

• Adacel: Formulated with the same antigens found in Daptacel, but with reduced quantities of tetanus and pertussis. Use in the primary immunization series or to complete the primary series has not been evaluated.

• Boostrix: Formulated with the same antigens found in Infanrix, but in reduced quantities. Use in the primary immunization series or to complete the primary series has not been evaluated.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Antipyretics: Per the manufacturer, antipyretic prophylaxis may be considered for patients at high risk for seizures. However, antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin 2014).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).

Dosage Forms Considerations

Tdap vaccines (Adacel, Boostrix) are used in pediatric patients ≥7 years of age; DTaP vaccines (Daptacel, Infanrix) are for use in pediatric patients 6 weeks to <7 years of age. Tdap vaccines contain less diphtheria toxoid and pertussis antigens than DTaP vaccines; the vaccines are not interchangeable (CDC/ACIP [Havers 2020]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intramuscular:

Adacel: Diphtheria 2 Lf, tetanus 5 Lf, and acellular pertussis antigens [detoxified pertussis toxin 2.5 mcg] per 0.5 mL (0.5 mL) [contains aluminum phosphate, formaldehyde solution, phenoxyethanol]

Daptacel: Diphtheria 15 Lf units, tetanus 5 Lf units, and acellular pertussis antigens [detoxified pertussis toxin 10 mcg] per 0.5 mL (0.5 mL) [contains aluminum phosphate, formaldehyde solution, phenoxyethanol]

Infanrix: Diphtheria 25 Lf, tetanus 10 Lf, and acellular pertussis antigens [inactivated pertussis toxin 25 mcg] per 0.5 mL (0.5 mL) [contains formaldehyde solution, polysorbate 80]

Suspension, Intramuscular [preservative free]:

Boostrix: Diphtheria 2.5 Lf, tetanus 5 Lf, and acellular pertussis antigens [inactivated pertussis toxin 8 mcg] per 0.5 mL (0.5 mL) [contains formaldehyde solution, polysorbate 80]

Suspension Prefilled Syringe, Intramuscular [preservative free]:

Boostrix: 5-2.5-18.5 LF-MCG/0.5 (0.5 mL) [contains formaldehyde solution, polysorbate 80]

Generic Equivalent Available: US

Pricing: US

Suspension (Adacel Intramuscular)

5-2-15.5 lf-mcg/0.5 (per 0.5 mL): $56.95

Suspension (Boostrix Intramuscular)

5-2.5-18.5 lf-mcg/0.5 (per 0.5 mL): $56.42

Suspension (Daptacel Intramuscular)

23-15-5 (per 0.5 mL): $34.72

Suspension (Infanrix Intramuscular)

25-58-10 (per 0.5 mL): $34.10

Suspension Prefilled Syringe (Boostrix Intramuscular)

5-2.5-18.5 lf-mcg/0.5 (per 0.5 mL): $56.42

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intramuscular:

Adacel: Diphtheria 2 Lf, tetanus 5 Lf, and acellular pertussis antigens [detoxified pertussis toxin 2.5 mcg] per 0.5 mL (0.5 mL) [contains aluminum phosphate, phenoxyethanol]

Suspension Prefilled Syringe, Intramuscular:

Boostrix: 5-2.5-18.5 LF-MCG/0.5 (0.5 mL)

Administration: Adult

IM: Administer IM. Shake suspension well to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, vaccine information statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Adacel, Boostrix: Administer IM preferably into deltoid muscle of upper arm. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref).

For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).

Administration: Pediatric

IM: Shake vial well before withdrawing the dose to obtain a homogeneous, turbid, white suspension; do not use if resuspension does not occur. Administer IM into midlateral aspect of the thigh in infants and small children; administer in the deltoid area to older children and adolescents; not for IV, intradermal, or SUBQ administration. If injecting in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, vaccine information statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be entered into the patient's permanent medical record.

For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure on the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).

Medication Guide and/or Vaccine Information Statement (VIS)

DTaP: In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/dtap.html.

Tdap: In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/tdap.html.

Use: Labeled Indications

Diphtheria, tetanus, and pertussis disease prevention:

Daptacel, Infanrix (DTaP): Active immunization against diphtheria, tetanus, and pertussis in patients from 6 weeks through 6 years of age (prior to seventh birthday); wound management for the prevention of tetanus.

Adacel (Tdap): Active booster immunization against diphtheria, tetanus, and pertussis in persons 10 to 64 years of age; wound management for the prevention of tetanus; immunization during the third trimester of pregnancy to prevent pertussis in infants <2 months of age.

Boostrix (Tdap): Active booster immunization against diphtheria, tetanus, and pertussis in persons ≥10 years of age; wound management for the prevention of tetanus; immunization during the third trimester of pregnancy to prevent pertussis in infants <2 months of age.

The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for the following (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]):

Infants and children 6 weeks to <7 years of age (DTaP):

• Routine: Primary immunization against diphtheria, tetanus and pertussis.

• Wound management: To prevent tetanus in patients with unknown or <3 doses of previous tetanus vaccination. Tetanus immune globulin is also recommended for some wounds; refer to full Centers for Disease Control and Prevention (CDC)/Advisory Committee on Immunization Practices (ACIP) recommendations for details.

Children 7 to 10 years of age (Tdap):

• Catch-up: Children not fully immunized with DTaP vaccine should receive a single dose of Tdap, preferably as the first dose in the catch-up series. Children never vaccinated against diphtheria, tetanus, or pertussis, or whose vaccination status is not known, should receive a series of 3 vaccinations containing tetanus and diphtheria toxoids; at least 1 dose should be Tdap (preferably the first dose).

• Wound management: To prevent tetanus in patients with unknown or <3 doses of previous tetanus vaccine, or who have not received a tetanus-containing vaccine recently (ie, 10 years for clean and minor wounds; 5 years for all other wounds). Tetanus immune globulin is also recommended for some wounds; refer to full CDC/ACIP recommendations for details. Patients not fully immunized presenting for wound management may need additional catch-up doses as above.

Children ≥11 years of age and adolescents (Tdap):

• Routine: A single dose of Tdap as a routine booster dose in individuals who have completed the recommended or catch-up childhood DTaP vaccination series prior to 10 years of age (preferred age of administration is 11 to 12 years).

• Catch-up: Individuals never vaccinated against diphtheria, tetanus, or pertussis, or whose vaccination status is not known should receive a series of three vaccinations containing tetanus and diphtheria toxoids; at least 1 dose should be Tdap (preferably the first dose).

• Wound management: To prevent tetanus in patients with unknown or <3 doses of previous tetanus vaccine or who have not received a tetanus-containing vaccine recently (ie, 10 years for clean and minor wounds; 5 years for all other wounds) Tdap or Td may be used, regardless of time since last Tdap dose. Tetanus immune globulin is also recommended for some wounds; refer to full CDC/ACIP recommendations for details.

Pregnant patients (Tdap):

• Routine: Pregnant patients should receive a single dose of Tdap with each pregnancy, regardless of previous vaccination status, preferably during the early part of 27 to 36 weeks' gestation.

• Catch-up: If the patient has never received a dose of Tdap AND did not receive a dose during pregnancy, a dose should be administered immediately postpartum.

• Wound management: Tdap is recommended as the preferred tetanus wound management during pregnancy.

Adults ≥19 years of age (including adults ≥65 years of age) (Tdap):

• Routine: A single dose of Tdap should be given to all patients who have not previously received Tdap or for whom their vaccine status is unknown. Following administration of Tdap, either Tdap or Td vaccine can be used for routine boosters administered every 10 years.

• Catch-up: Patients never vaccinated against diphtheria, tetanus, or pertussis, or whose vaccination status is not known, should receive a series of 3 vaccinations containing tetanus and diphtheria toxoids; all 3 doses may be, and at least 1 of the doses should be, Tdap (preferably the first dose). The following patients, who have not yet received Tdap or for whom vaccine status is not known, should receive a single dose of Tdap as soon as feasible:

- Close contacts of children <12 months of age; Tdap should ideally be administered at least 2 weeks prior to beginning close contact.

- Health care providers with direct patient contact.

All patients who have recovered from tetanus or diphtheria infection:

• Because tetanus or diphtheria infection does not confer life-long immunity, active vaccination should be initiated at the time of recovery from the illness (according to the schedule). If the primary tetanus vaccination series has been completed, then a booster dose should be administered as soon as feasible during convalescence. Persons with unknown or uncertain previous tetanus vaccination histories should begin the 3-dose tetanus and diphtheria toxoids vaccination series.

Medication Safety Issues

Sound-alike/look-alike issues:

Adacel (Tdap) may be confused with Daptacel (DTaP).

Tdap (Adacel, Boostrix) may be confused with DTaP (Daptacel, Infanrix, Tripedia).

Administration issues:

Carefully review product labeling to prevent inadvertent administration of Tdap when DTaP is indicated. Tdap contains lower amounts of diphtheria toxoid and some pertussis antigens than DTaP.

DTaP is indicated for use in persons 6 weeks through 6 years of age.

Tdap is FDA-approved for use in persons ≥10 years of age but is recommended by the Advisory Committee on Immunization Practices for use beginning at 7 years of age as part of the catch-up immunization series (CDC/ACIP [Havers 2020]).

Guidelines are available in case of inadvertent administration of these products; refer to CDC recommendations, April 2018 and January 2020 available at https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6903a5-H.pdf (CDC/ACIP [Liang 2018]) and https://www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6702a1-H.pdf (CDC/ACIP [Havers 2020]).

Other safety concerns:

DTaP: Diphtheria and tetanus toxoids and acellular pertussis vaccine.

DTP: Diphtheria and tetanus toxoids and pertussis vaccine (unspecified pertussis antigens).

DTwP: Diphtheria and tetanus toxoids and whole-cell pertussis vaccine (no longer available on US market).

Tdap: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification

Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification

Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine: Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine may diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine. More specifically, prior administration of the diphtheria and tetanus toxoids, and acellular pertussis vaccine may diminish antibody response to the meningococcal (groups A / C / Y / and W-135) diphtheria conjugate vaccine in some patients. Management: Administer the meningococcal (groups A / C / Y and W-135) conjugate vaccine (Menactra brand) before or concurrently with the diphtheria and tetanus toxoids, and acellular pertussis vaccine (Daptacel brand) in children 4 to 6 years of age. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification

Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification

Pregnancy Considerations

Nonlive bacterial vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2023]). Specifically, an increased risk of miscarriage, stillbirth, preterm birth, SGA, or major birth defects has not been observed following maternal use of the Tdap vaccine (CDC/ACIP [Liang 2018]; CDC [Havers 2020]; Kerr 2020; Mohammed 2021; Moro 2016; Panagiotakopoulos 2020; Vygen-Bonnet 2020; Zheteyeva 2012).

Following Tdap vaccination, maternal antibodies reach the fetus and provide protection against pertussis in infants too young to be immunized (CDC [Havers 2020]; CDC/ACIP [Liang 2018]). Concentrations of pertussis toxin antibodies are significantly increased in cord blood when maternal vaccination is administered per current CDC guidelines (Healy 2018; Perrett 2020). Maternal Tdap vaccination during pregnancy decreases the risk of infant pertussis disease, hospitalization, and death (Kandeil 2020; Mott 2021; Santana 2021). Neonatal and obstetrical tetanus is also decreased following maternal Tdap vaccination (CDC [Havers 2020]; CDC/ACIP [Liang 2018]).

All patients should receive a single dose of Tdap during each pregnancy regardless of previous vaccination status. Although the vaccine may be given any time during pregnancy, it should be administered between 27 and 36 weeks gestation, preferably during the early part of this time period, to maximize passive antibody transfer to the infant. Alternately, administration of Tdap can be given immediately postpartum to all patients who have not previously been vaccinated with Tdap in order to protect the mother and infant from pertussis (ACIP [Kroger 2023]; CDC/ACIP [Liang 2018]).

In case of an ongoing local pertussis epidemic, pregnant patients should be vaccinated with Tdap for their own protection as is recommended for nonpregnant patients, regardless of gestational age (ACOG 2017; CDC/ACIP [Havers 2020]).

If a tetanus toxoid-containing vaccine is needed as standard care for wound management, Tdap is preferred over Td, regardless of gestational age if otherwise indicated; however, if Tdap is used prior to 27 to 36 weeks' gestation in these instances, patients should not receive >1 dose during the same pregnancy (ACOG 2017; CDC/ACIP [Havers 2020]).

Data collection to monitor pregnancy and infant outcomes following exposure to Tdap vaccine is ongoing. Pregnancy registries have been established for patients who may become exposed to Boostrix (888-452-9622) or Adacel (800-822-2463) while pregnant.

Breastfeeding Considerations

It is not known if components of this vaccine are present in breast milk.

However, pertussis-specific antibodies are present in breast milk following vaccination. Information is available from a study that compared breast milk from lactating women vaccinated with Tdap vaccine between 24 and 32 weeks’ gestation (n=213) to women not vaccinated during pregnancy (n=27). Breast milk and maternal serum samples were collected at 72 hours, 4, 8, and 12 weeks postpartum. Concentrations of pertussis-specific anti-PT IgA and IgG were increased in breast milk of vaccinated mothers, and this was observed for both term and preterm deliveries (Orije 2021).

According to the manufacturer, the decision to breastfeed following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of vaccination to the mother; however, breastfeeding is not a contraindication to vaccine administration. Patients who have not previously had a dose of Tdap should receive a dose postpartum to help prevent pertussis in infants <12 months of age (CDC/ACIP [Liang 2018]). Administration does not affect the safety of breastfeeding for the mother or the infant. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Mechanism of Action

Promotes active immunity to diphtheria, tetanus, and pertussis by inducing production of specific antibodies.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: D.T. Coq | Infanrix;
(AR) Argentina: Adacel | Bustrix | Triacel | Vacuna triple biol;
(AT) Austria: Diphteria tetanus pertussis anatoxal | Infanrix;
(AU) Australia: Adacel | Boostrix | Infanrix | Infanrix dtpa | Tripacel;
(BE) Belgium: Boostrix | Combivax | Infanrix | Triaxis;
(BG) Bulgaria: Adacel | Infanrix;
(BO) Bolivia, Plurinational State of: Adacel;
(BR) Brazil: Adacel | Dtp | Infanrix | Pertacel | Refortrix | Vacina adsorvida difteria tetano e pertussis (DTP) | Vacina adsorvida difteria, tetano e pertussis (acelular) | Vacina adsorvida difteria, tetano e pertussis (acelular)/dTpa;
(CH) Switzerland: Infanrix dtpa;
(CL) Chile: Adacel | Boostrix;
(CN) China: Diphtheria, tetanus and acellular pertussis combined vaccine absorbed;
(CO) Colombia: Adacel | Anatoxal di te per;
(CU) Cuba: Dtp vax;
(CZ) Czech Republic: Adacel | Boostrix;
(DE) Germany: Boostrix | Covaxis | Dpt merieux | Infanrix | Tdap immun;
(DO) Dominican Republic: Adacel | Boostrix;
(EC) Ecuador: Adacel | Anatoxal di te per | Boostrix;
(EE) Estonia: Infanrix;
(EG) Egypt: D T P;
(ES) Spain: Boostrix | Infanrix;
(FI) Finland: Boostrix | Ditekibooster | Infanrix | Triaxis;
(FR) France: D.t.coq/d.t.p.;
(GB) United Kingdom: Dip tet per ad | Infanrix;
(GR) Greece: Boostrix | Infanrix;
(HK) Hong Kong: Adacel | Diftetkok | Dt coq | Infanrix | Tripacel | Triple antigen;
(HR) Croatia: Boostrix | Refortrix;
(HU) Hungary: Adacel | Boostrix;
(ID) Indonesia: Adacel | Boostrix | Dtp vaccine | Infanrix | Tripacel | Tritanrix | Vaccine diph+pertu+tet;
(IE) Ireland: Boostrix | Infanrix | Triaxis;
(IL) Israel: Infanrix;
(IN) India: Abhay tag | Adacel | Comvac 3 | Diphtheria, Tetanus & Pertu. Vacc. (Ads.) I.P | Dpt | Tripacel | Triple antigen;
(IT) Italy: Anatoxal di te per | Boostrix | Infanrix | Triaxis | Tribaccine | Vaccino dpt;
(JO) Jordan: Adacel;
(KE) Kenya: Boostrix | Diphtheria tetanus pertussis vaccine adsorbed | Infanrix;
(KR) Korea, Republic of: Adacel | Boostrix | Boryung dtap | Dpt kovax | Dpt3 vaccine | Dtap | Infanrix | Kaketsuken dtap vaccine | P-d.t.vax | P-d.t.vax II | Sk Dtap Vaccine;
(LB) Lebanon: Infanrix | Tripacel;
(LT) Lithuania: Adacel | Tripacel;
(LU) Luxembourg: Boostrix | Infanrix dtpa | Triamer | Triaxis;
(LV) Latvia: Infanrix dtp | Tripacel;
(MA) Morocco: D.T. Coq;
(MX) Mexico: Adacelboost | Boostrix | Dipertix | Triacel | Vacuna adsorbida antidifterica, antitetanica y contra la tos ferina;
(MY) Malaysia: Adacel | Dtp vaccine | Infanrix | Tripacel | Triple antigen;
(NL) Netherlands: Boostrix;
(NO) Norway: Boostrix | Infanrix;
(NZ) New Zealand: Adacel | Boostrix | Infanrix;
(PE) Peru: Adacel | Anatoxal di te per | Boostrix;
(PH) Philippines: Boostrix | Di te per | Dif per tet all | Dpt dt coq adsorbed | Infanrix;
(PK) Pakistan: Boostrix | Di te per anatoxal | Infanrix;
(PL) Poland: Adacel | Boostrix | Dtp szczepionka bloniczo tezcowo krztuscowa adsorbowana | Infanrix dtpa szczepionka przeciwko blonicy, | Tdap Szczepionka SSI | Tripacel;
(PR) Puerto Rico: Adacel | Daptacel | Infanrix | Tripedia;
(PT) Portugal: Anatoxal di te per | Boostrix | Infanrix | Triaxis;
(PY) Paraguay: Adacel;
(QA) Qatar: Boostrix | Infanrix;
(RO) Romania: Adacel | Infanrix;
(RU) Russian Federation: Adacel | Adsorbed pertussis-diphtheria-tetanus vaccine | Infanrix;
(SA) Saudi Arabia: Infanrix | Vaccin dt coq;
(SE) Sweden: Ditekibooster | Triaxis;
(SG) Singapore: Boostrix | Di te per anatoxal | Infanrix | Tripacel | Triple antigen vaccine;
(SI) Slovenia: Vaccinum diphtheriae tetani pertussis;
(SK) Slovakia: Boostrix | D.t.coq/d.t.p. | Infanrix;
(SV) El Salvador: Adacel | Boostrix;
(TH) Thailand: Adacel | Boostagen | Boostrix | Di te per anatoxal | Dif per tet all | Dpt Vaccine | DTCOQ/DTP | Dtp vaccine | Infanrix | Tripacel;
(TN) Tunisia: Vaccin dt coq;
(TR) Turkey: Adacel | Anatoxal di te per | Infanrix | Tripacel;
(TW) Taiwan: Boostrix | Di te per | Dpt | Infanrix | Sk dpt3 | Tripacel;
(UA) Ukraine: Boostrix | Infanrix;
(UG) Uganda: Diphtheria tetanus pertussis vaccine adsorbed;
(UY) Uruguay: Adacel | Boostrix;
(VE) Venezuela, Bolivarian Republic of: Adacel | Boostrix;
(ZA) South Africa: Adacel | Boostrix | Dtp merieux | Tritanrix;
(ZM) Zambia: Diphtheria tetanus pertussis vaccine adsorbed;
(ZW) Zimbabwe: Diphtheria - tetanus - pertussis vaccine adsorbed

Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; January 2023.
Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; May 2023.
Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) [product monograph]. Toronto, Ontario, Canada: Sanofi Pasteur Ltd; May 2023.
Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice, Immunization and Emerging Infections Expert Work Group. Committee Opinion No. 718: Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination. Obstet Gynecol. 2017;130(3):e153-e157. doi:10.1097/AOG.0000000000002301 [PubMed 28832489]
Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) [prescribing information]. Durham, NC: GlaxoSmithKline; November 2022.
Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) [prescribing information]. Durham, NC: GlaxoSmithKline; October 2023.
Boostrix (combined diphtheria, tetanus, and acellular pertussis vaccine, adsorbed) [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline Inc; November 2023.
Broder KR, Cortese MM, Iskander JK, et al. Advisory Committee on Immunization Practices (ACIP). Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(RR-3):1-34. [PubMed 16557217]
Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine from the Advisory Committee on Immunization Practices, 2010. MMWR Morb Mortal Wkly Rep. 2011;60(1):13-15. [PubMed 21228763]
Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in adults aged 65 years and older − Advisory Committee on Immunization Practices (ACIP), 2012 [published correction appears in MMWR Morb Mortal Wkly Rep. 2012;61(27):515]. MMWR Morb Mortal Wkly Rep. 2012;61(25):468-470. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6125a4.htm?s_cid=mm6125a4_e [PubMed 22739778]
Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women − Advisory Committee on Immunization Practices (ACIP), 2012. MMWR Morb Mortal Wkly Rep. 2013;62(7):131-135. [PubMed 23425962]
Chapman LE, Sullivent EE, Grohskopf LA, et al; Centers for Disease Control and Prevention (CDC). Recommendations for postexposure interventions to prevent infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus, and tetanus in persons wounded during bombings and other mass-casualty events—United States, 2008: recommendations of the Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 2008;57(RR-6):1-21. [PubMed 21293327]
Cohen V, Jellinek SP, Teperikidis L, Berkovits E, Goldman WM. Room-temperature storage of medications labeled for refrigeration. Am J Health-Syst Pharm. 2007;64(16):1711-1715. [PubMed 17687059]
Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don't aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303-306. [PubMed 27166466]
Daptacel (diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; August 2023.
Foster SL, Davis MV. Vaccine administration: preventing serious shoulder injuries. J Am Pharm Assoc (2003). 2013;53(1):102-103. doi:10.1331/JAPhA.2013.13503 [PubMed 23636163]
Havers FP, Moro PL, Hunter P, Hariri S, Bernstein H. Use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines: updated recommendations of the Advisory Committee on Immunization Practices - United States, 2019. MMWR Morb Mortal Wkly Rep. 2020;69(3):77-83. doi:10.15585/mmwr.mm6903a5 [PubMed 31971933]
Healy CM, Rench MA, Swaim LS, et al. Association between third-trimester Tdap immunization and neonatal pertussis antibody concentration. JAMA. 2018;320(14):1464-1470. doi:10.1001/jama.2018.14298 [PubMed 30304426]
Infanrix (diphtheria and tetanus toxoids, acellular pertussis vaccine, adsorbed) [prescribing information]. Durham, NC: GlaxoSmithKline; October 2023.
Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
Kandeil W, van den Ende C, Bunge EM, Jenkins VA, Ceregido MA, Guignard A. A systematic review of the burden of pertussis disease in infants and the effectiveness of maternal immunization against pertussis. Expert Rev Vaccines. 2020;19(7):621-638. doi:10.1080/14760584.2020.1791092 [PubMed 32772755]
Kerr SM, Van Bennekom CM, Mitchell AA. Tetanus, diphtheria, and pertussis vaccine (Tdap) in pregnancy and risk of major birth defects in the offspring. Birth Defects Res. 2020;112(5):393-403. doi:10.1002/bdr2.1642 [PubMed 31903700]
Kim DK, Riley LE, Harriman KH, Hunter P, Bridges CB. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older - United States, 2017. MMWR Morb Mortal Wkly Rep. 2017;66(5):136-138. [PubMed 28182599]
Kretsinger K, Broder KR, Cortese MM, et al. Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices; Healthcare Infection Control Practices Advisory Committee. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR Recomm Rep. 2006;55(RR-17):1-37. [PubMed 17167397]
Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed May 2, 2023.
Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(2):1-44. doi:10.15585/mmwr.rr6702a1 [PubMed 29702631]
Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
Mohammed H, Roberts CT, Grzeskowiak LE, et al. Safety of maternal pertussis vaccination on pregnancy and birth outcomes: a prospective cohort study. Vaccine. 2021;39(2):324-331. doi:10.1016/j.vaccine.2020.11.052 [PubMed 33280854]
Moro PL, Cragan J, Tepper N, et al. Enhanced surveillance of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011-2015. Vaccine. 2016;34(20):2349-2353. doi:10.1016/j.vaccine.2016.03.049 [PubMed 27013434]
Mott K, Huybrechts KF, Glynn RJ, Mogun H, Hernández-Díaz S. Tetanus, diphtheria, acellular pertussis vaccination during pregnancy and risk of pertussis in the newborn in publicly and privately insured mother-infant pairs in the United States. Pediatr Infect Dis J. 2021. doi:10.1097/INF.0000000000003099 [PubMed 33657597]
National Advisory Committee on Immunization (NACI). Principles of vaccine interchangeability: Canadian Immunization Guide. Updated February 2016. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-1-key-immunization-information/page-7-principles-vaccine-interchangeability.html. Accessed July 15, 2020.
National Advisory Committee on Immunization (NACI). Tetanus toxoid: Canadian immunization guide for health professionals. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-22-tetanus-toxoid.html. Updated February 21, 2020. Accessed September 22, 2021.
Orije MRP, Larivière Y, Herzog SA, et al. Breast milk antibody levels in Tdap vaccinated women after preterm delivery. Clin Infect Dis. 2021:ciab260. doi:10.1093/cid/ciab260 [PubMed 33768227]
Panagiotakopoulos L, McCarthy NL, Tepper NK, et al. Evaluating the association of stillbirths after maternal vaccination in the vaccine safety datalink. Obstet Gynecol. 2020;136(6):1086-1094. doi:10.1097/AOG.0000000000004166 [PubMed 33156197]
Perrett KP, Halperin SA, Nolan T, et al. Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: evidence from a randomized, placebo-controlled trial. Vaccine. 2020;38(8):2095-2104. doi:10.1016/j.vaccine.2019.10.105 [PubMed 31776029]
Prymula R, Siegrist CA, Chlibek R, et al. Effect of Prophylactic Paracetamol Administration at Time of Vaccination on Febrile Reactions and Antibody Responses in Children: Two Open-Label, Randomised Controlled Trials. Lancet. 2009;374(9698):1339-1350. [PubMed 19837254]
Refer to manufactuer's labeling.
Robinson CL, Romero JR, Kempe A, Pellegrini C, Szilagyi P. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger - United States, 2018. MMWR Morb Mortal Wkly Rep. 2018;67(5):156-157. [PubMed 29420458]
Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):e44-e100. [PubMed 24311479]
Saari TN; American Academy of Pediatrics Committee on Infectious Diseases. Immunization of preterm and low birth weight infants. Pediatrics. 2003;112(1 Pt 1):193‐198. doi:10.1542/peds.112.1.193 [PubMed 12837889]
Santana CP, Luhm KR, Shimakura SE. Impact of Tdap vaccine during pregnancy on the incidence of pertussis in children under one year in Brazil - a time series analysis. Vaccine. 2021;39(6):976-983. doi:10.1016/j.vaccine.2020.12.056 [PubMed 33446384]
Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
Use of diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine as a five-dose series. Supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2000;49(RR-13):1-8. [PubMed 11106289]
Vygen-Bonnet S, Hellenbrand W, Garbe E, et al. Safety and effectiveness of acellular pertussis vaccination during pregnancy: a systematic review. BMC Infect Dis. 2020;20(1):136. doi:10.1186/s12879-020-4824-3 [PubMed 32054444]
World Health Organization (WHO). Guiding principles for immunization activities during the COVID-19 pandemic: interim guidance, 26 March 2020. Published March 26, 2020. https://apps.who.int/iris/handle/10665/331590
Zheteyeva YA, Moro PL, Tepper NK, et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. Am J Obstet Gynecol. 2012;207(1):59.e1-e7. [PubMed 22727350]

Topic 9373 Version 289.0

خرید پکیج

Diphtheria and tetanus toxoids and acellular pertussis vaccines (DTaP [age <7 years] and Tdap [age ≥7 years]): Drug information