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Diphtheria / Tetanus Toxoids / Acellular Pertussis Vaccine

( DTaP/Tdap ) Pronouncation: (diff-THEER-ee-uh/TET-ah-nus/ay-SELL-yoo-ler per-TUSS-uss vaccine)
Class: Toxoid

Trade Names:
Adacel
- Injection 2 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 3 mcg pertactin, 5 mcg filamentous hemagglutinin (FHA), 2.5 mcg detoxified pertussis toxins, 5 mcg fimbriae types 2 and 3 per mL

Trade Names:
Boostrix
- Injection 2.5 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 2.5 mcg pertactin, 8 mcg FHA, 8 mcg inactivated pertussis toxins per 0.5 mL

Trade Names:
Daptacel
- Injection 15 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 10 mcg pertussis toxoid, 5 mcg FHA, 3 mcg pertactin, 5 mcg fimbriae types 2 and 3 per 0.5 mL

Trade Names:
Infanrix
- Injection 25 Lf units diphtheria, 10 Lf units tetanus toxoid, 25 mcg pertussis toxin, 25 mcg FHA, 8 mcg pertactin per 0.5 mL

Trade Names:
Tripedia
- Injection 6.7 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 46.8 mcg pertussis antigens (approximately 23.4 mcg each of inactivated pertussis toxin and FHA) per 0.5 mL

Pharmacology

Diphtheria and tetanus toxoids induce antibodies against toxins made by Corynebacterium diphtheriae and Clostridium tetani . Pertussis vaccine protects against Bordetella pertussis .

Indications and Usage

Per CDC, Tdap is for use in adults and children 10 yr of age and older, and DTaP is for use in infants and children younger than 7 yr of age.

Adacel (Tdap)

Active booster immunization against diphtheria, tetanus, and pertussis as a single dose in persons 11 to 64 yr of age.

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Boostrix (Tdap)

Active booster immunization against diphtheria, tetanus, and pertussis as a single dose in persons 10 to 18 yr of age.

Daptacel , Infanrix , Tripedia (DTaP)

Active immunization against diphtheria, tetanus, and pertussis in infants and children 6 wk to 6 yr of age (prior to seventh birthday).

Contraindications

Encephalopathy within 7 days of previous administration of DTP, Tdap, or DTaP that is not attributable to another cause; progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy), in addition, pertussis vaccine should not be administered to persons with these conditions until a treatment regimen has been established and condition has stabilized; hypersensitivity to any component of the vaccine; history of serious allergic reaction temporarily associated with a previous dose of vaccine or any component of the vaccine.

Daptacel , Infanrix , Tripedia

Use in adults or children 7 yr of age and older; if contraindication to pertussis vaccine component occurs, substitute diphtheria and tetanus toxoids for pediatric use (DT) for each remaining dose; defer elective immunization procedures during outbreak of poliomyelitis because of risk of provoking paralysis.

Dosage and Administration

It is recommended that the same brand of DTaP ( Daptacel , Infanrix , Tripedia ) be given for all doses in the immunization series because no data exist on the interchangeability of DTaP vaccines. Tdap vaccines ( Adacel , Boostrix ) are not interchangeable with DTaP vaccines.

Adacel
Adults and Children 11 yr of age and older

IM 0.5 mL.

Boostrix
Children 10 to 18 yr of age

IM 0.5 mL.

Daptacel
Children

IM Immunization is 4 doses of 0.5 mL at 2, 4, and 6 mo of age at intervals of 6 to 8 wk, and at 15 to 20 mo of age. Interval between third and fourth dose should be 6 to 12 mo.

Infanrix
Children

IM Primary immunization series is 3 doses of 0.5 mL at 4- to 8-wk intervals (preferably 8 wk). Customarily, the first dose is given at 2 mo of age (but may be given at 6 wk of age). A fourth dose (booster immunization) is recommended at 15 to 20 mo of age (interval between third and fourth dose is 6 to 12 mo). A fifth dose is recommended at 4 to 6 yr of age in those who received all 4 doses by the fourth birthday. If the fourth dose is given after the fourth birthday, a fifth dose prior to school entry is not necessary.

Tripedia
Children

IM Primary immunization series is 3 doses of 0.5 mL at 4- to 8-wk intervals. Customarily, the first dose is given at 2 mo of age (but may be given at 6 wk of age). A fourth dose is recommended at 15 to 18 mo of age (interval between third and fourth dose is 6 to 12 mo). A fifth dose is recommended at 4 to 6 yr of age, preferably prior to school entry. If the fourth dose is given after the fourth birthday, a fifth dose prior to school entry is not necessary.

General Advice

  • For IM administration only. Not for intradermal, subcutaneous, IV, or intra-arterial administration.
  • Have epinephrine injection and other appropriate agents and equipment immediately available should an acute anaphylactic reaction occur.
  • Attempt to use the same brand of vaccine for the entire series; however, when this is not possible, use any DTaP vaccine to continue or complete series.
  • Interruption of recommended schedule with a delay between doses does not interfere with development of final immunity. There is no need to start the series over again.
  • Use vaccine as supplied; no dilution or reconstitution is necessary. Do not mix with any other vaccine in the same vial or syringe.
  • Shake vial or syringe vigorously immediately prior to use to obtain a uniform suspension. Suspension should be homogeneous and white. Do not use if particulate matter or discoloration are noted or if vaccine cannot be resuspended.
  • Rotate vial or syringe in palm to bring contents to room temperature before administering; administer immediately.
  • Discard any vaccine remaining in vial after withdrawing dose.
  • Administer IM in anterolateral thigh in infants (younger than 1 yr of age) or deltoid muscle of upper arm (for older children and adults). Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel.
  • May administer vaccine in conjunction with injectable polio, Haemophilus influenza type b, hepatitis B, varicella, and measles, mumps, pneumococcal conjugate, and rubella virus vaccines using separate syringes and different sites for administration.
  • Tripedia may be used to reconstitute Haemophilus B conjugate vaccine for administration of fourth dose to children 15 to 18 mo of age.
  • Always record manufacturer's name and vaccine lot number in patient's permanent medical record file, along with date of administration, and name and title of person administering vaccine.
  • Adacel : 5 yr should have elapsed since the person's last dose of tetanus toxoid, diphtheria, and/or pertussis–containing vaccine.

Storage/Stability

Store vials and syringes in refrigerator (35° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Drug Interactions

Anticoagulants

Give DTaP/Tdap with caution to patients on anticoagulant therapy.

Immunosuppressants

May reduce vaccine's efficacy.

Influenza vaccine

To attribute causality of adverse reactions, do not give influenza vaccine within 3 days of pertussis vaccination.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Boostrix

Myocarditis (postmarketing).

Daptacel

Cyanosis (postmarketing).

Infanrix

Cyanosis (postmarketing).

CNS

Adacel

Headache (44%); tiredness (30%); hyposthesia, paresthesia, vasovagal syncope (postmarketing).

Boostrix

Headache (43%); fatigue (37%); convulsion, encephalitis, facial palsy, paresthesia (postmarketing).

Daptacel

Fussines (76%); fretfulness (40%); drowsiness (33%); anorexia (11%); convulsions, febrile convulsion, grand mal convulsion, hypotonia, hypotonic-hyporesponsive episode, partial seizures, somnolence, screaming (postmarketing).

Infanrix

Drowsiness (38%); anorexia (12%); fussiness (9%); convulsions, crying, encephalopathy, hypotonia, hypotonic-hyporesponsive episode, irritability, somnolence (postmarketing).

Tripedia

Drowsiness (29%); irritability (25%); anorexia (10%); fussiness (6%); autism, convulsion, encephalopathy, grand mal convulsion, hypotonia, neuropathy, somnolence (postmarketing).

Dermatologic

Adacel

Rash (3%); pruritus, urticaria (postmarketing).

Boostrix

Exanthem, Henoch-Schonlein purpura, rash (postmarketing).

Infanrix

Erythema, pruritus, rash, urticaria (postmarketing).

GI

Adacel

Nausea (13%); diarrhea (10%); vomiting (5%).

Boostrix

GI symptoms including abdominal pain, diarrhea, nausea, vomiting (26%).

Daptacel

Vomiting (7%); diarrhea, nausea (postmarketing).

Infanrix

Vomiting (7%); diarrhea, intussusception (postmarketing).

Tripedia

Vomiting (5%).

Hematologic-Lymphatic

Adacel

Lymph node swelling (7%).

Boostrix

Lymphadenitis, lymphadenopathy (postmarketing).

Infanrix

Idiopathic thrombocytopenic purpura, lymphadenopathy, thrombocytopenia (postmarketing).

Tripedia

Idiopathic thrombocytopenic purpura (postmarketing).

Hypersensitivity

Boostrix

Anaphylactic reaction, arthus-type hypersensitivity.

Daptacel

Allergic reaction, anaphylactic reaction (edema, face edema, face swelling, generalized rash and other types of rash, pruritus), hypersensitivity (postmarketing).

Infanrix

Anaphylactic reaction, hypersensitivity (postmarketing).

Tripedia

Anaphylactic reaction (postmarketing).

Local

Adacel

Pain (78%); erythema (25%); swelling (21%); injection-site bruising, sterile abscess (postmarketing).

Boostrix

Pain (75%); redness (48%); swelling (39%); increase in arm circumference (28%); induration, inflammation, local reaction, mass, nodule, warmth (postmarketing).

Daptacel

Tenderness (50%); increased arm circumference (30%); redness (17%); swelling (12%); cellulitis, injection-site abscess, injection-site mass, injection-site nodule, injection-site pain, injection-site rash.

Infanrix

Redness (59%); swelling (50%); pain (27%); injection-site reactions (postmarketing).

Tripedia

Redness (33%); swelling (28%); pain (21%).

Musculoskeletal

Adacel

Body ache or muscle weakness (30%); sore and swollen joints (11%); muscle spasms, myelitis, myositis (postmarketing).

Boostrix

Arthralgia, back pain, myalgia (postmarketing).

Infanrix

Limb swelling (postmarketing).

Miscellaneous

Adacel

Chills (15%); fever (5%).

Boostrix

Fever (14%); insulin-dependent diabetes mellitus (postmarketing).

Daptacel

Crying (59%); decreased activity (51%); fever (24%).

Infanrix

Fever (7%); cellulitis, ear pain, respiratory tract infection, sudden infant death syndrome (postmarketing).

Tripedia

Fever (25%); apnea, sudden infant death syndrome (postmarketing).

Precautions

Monitor

When child returns for next dose in series, question parent or guardian about serious adverse reactions with previous dose. Note any adverse reactions that would contraindicate additional pertussis vaccine; if reactions are observed, complete immunization series with DT. If any event listed in the US Department of Health and Human Services' Vaccine Injury Table or other serious adverse reactions occur, report them through the Vaccine Adverse Event Reporting System (VAERS) per organizational policy.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Adacel

Safety and efficacy not established in children younger than 11 yr of age.

Boostrix

Not indicated for use in patients younger than 10 yr of age or older than 18 yr of age.

Daptacel , Infanrix , Tripedia

Safety and efficacy in infants younger than 6 wk of age not established; contraindicated for persons 7 yr of age and older.

Elderly

Adacel

Safety and efficacy not established in individuals 65 yr of age and older.

Special Risk Patients

If any of the following occurs in temporal relation with receipt of either whole-cell pertussis DTP or DTaP, carefully consider decision to administer subsequent doses of vaccine containing pertussis component: temperature of at least 105°F within 48 h not caused by another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 h; persistent inconsolable crying lasting at least 3 h occurring within 48 h; or convulsions, with or without fever, occurring within 3 days. If the decision is made to withhold pertussis component, continue immunization with DT (Td if 7 yr of age and older). If Guillain-Barré syndrome occurs within 6 wk of receipt of prior vaccine containing tetanus toxoids, base decision to give subsequent doses of DTaP or any vaccine containing tetanus toxoids on potential benefits versus risks. Patients who experience serious Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoids usually have high serum tetanus antitoxin levels and should not be given Td or DTaP vaccines or even emergency doses of Td more frequently than every 10 yr, even if wound is neither clean nor minor.

Bleeding disorders

Use with caution in patients with bleeding disorders (eg, thrombocytopenia, hemophilia) or receiving anticoagulant therapy.

Convulsions/CNS disorders

Family history of seizures or other CNS disorders is not a contraindication to pertussis vaccine.

Febrile illness or acute infection

Defer immunization during course of illness. Minor respiratory illness, such as mild upper respiratory tract infection, is usually not a reason to defer immunization.

Immunodeficiency

May have diminished antibody response; defer immunization, if possible, until immunocompetency is restored.

Latex sensitivity

Stoppers for Daptacel and Tripedia vials, and tip cap and rubber plunger of Infanrix and Boostrix needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals.

Overdosage

Symptoms

None noted.

Patient Information

  • Explain name, action, and potential adverse reactions of vaccine. Review benefits and risks of the vaccine and importance of completing the immunization series.
  • Provide and review the Vaccine Information Statements prior to immunization.
  • Review immunization schedule.
  • Provide parent or guardian with immunization history record and record this immunization in patient's immunization record.
  • Advise patient, or parent or guardian of child with history of seizures or family member with seizure disorder that controlling fever after vaccination is very important. Advise parent or guardian to give the child an aspirin-free pain reliever (eg, acetaminophen, ibuprofen) when the shot is given and for the next 24 h, following package instructions.
  • Advise parent or guardian that the following problems occur frequently within 1 to 3 days after vaccination but are generally mild: fussiness, poor appetite, tiredness, vomiting.
  • Advise patient, parent, or guardian to use non-aspirin-containing OTC analgesics (eg, acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site.
  • Immediately notify health care provider if: vaccine recipient develops fever of 105°F or more; faints or persistently cries for more than 3 h within 48 h of receiving vaccine; has a seizure, with or without fever, within 7 days of receiving vaccine.
  • Instruct parent or guardian to immediately notify health care provider if change in mental alertness or unresponsiveness occurs within 7 days of receiving vaccination.
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