INFANRIX DTAP
  • INFANRIX DTAP

  • QTY 0.5 • 25-58-10 • VIAL • Near 77381

DIPHTHERIA and TETANUS TOXOIDS; PERTUSSIS VACCINE (dif THEER ee uh and TET n us TOK soids; per TUS iss VAK seen) is used to prevent diphtheria, tetanus, and pertussis infections.

INFANRIX DTAP Pediatric Monographs
  • General Administration Information
    For storage information, see the specific product information within the How Supplied section.
    -Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. These actions are required by the National Childhood Vaccine Injury Act of 1986.
    -Record the manufacturer and lot number of the vaccine; date of administration; and the name, address, and title of the person who administered the vaccine in the recipient's permanent medical record. These actions are required by the National Childhood Vaccine Injury Act of 1986.

    Route-Specific Administration

    Injectable Administration
    -Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
    Intramuscular Administration
    -Use vaccine as supplied; reconstitution is not necessary.
    -Shake vial vigorously just prior to withdrawing the dose to ensure a uniform, white, cloudy suspension. If the vaccine cannot be resuspended, discard it.
    -Do not mix with any other vaccine.
    -When Daptacel and Menactra are to be given together for children 4 through 6 years, the two vaccines should be administered concomitantly or Menactra should be administered prior to Daptacel. Clinical trials found a reduced meningococcal antibody response when Menactra was administered one month after Daptacel.
    -When concomitant administration of other vaccines or immunoglobulin is required, they should be given with different syringes and at different injection sites.
    -Storage of unopened vials:-Manufacturer recommendations: Store refrigerated at 2 to 8 degrees C (36 to 46 degrees F); do not freeze.
    -Off-label storage information (Infanrix only): According to a 2007 published article, storage of Infanrix (GlaxoSmithKline) at room temperature for up to 72 hours is acceptable. NOTE: Because changes in vaccine formulation may affect stability and effectiveness, confirmation of acceptable duration of storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended.


    Intramuscular (IM) Injection
    -Choose an appropriate length needle for intramuscular administration.-For the majority of infants < 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.
    -For children 1 to 2 years, a needle at least 1 inch long is preferred for administration into the thigh; a 5/8 inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90 degree angle.
    -For children >= 3 years, the needle size required for deltoid injection ranges from 5/8- to 1-inch.

    -Inject into the anterolateral aspect of the thigh (for infants < 1 year of age) or the deltoid muscle of the upper arm (usually suitable for older children). Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk. Of note, deltoid administration has been associated with a higher risk of local reactions to the DTaP vaccine that required medical attention in children 1 to 2 years of age.

    Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as to the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

    During 2 clinical trials with diphtheria/tetanus toxoids, pertussis vaccine, DTP, sudden infant death syndrome (SIDS) was reported in 0.4-0.8/1000 vaccinated infants. SIDS has been reported during post-marketing use of DTaP. The Institute of Medicine and other experts reviewed available data and found no evidence of a causal relationship between DTaP vaccination and SIDS.

    Immune-mediated adverse reactions have been observed with the use of diphtheria/tetanus toxoids; pertussis vaccine, DTP. Anaphylactoid reactions, anaphylactic shock, angioedema, urticaria; erythematous, macular, or maculopapular rash; generalized edema, pruritus, exanthem, Henoch-Schonlein purpura, and hypotension have been observed during post-marketing surveillance. Rash occurred in 2.7% of adolescents who received Tdap during clinical safety studies. Dyspnea has been noted. Instruct patients to report any signs and symptoms of a systemic reaction. Also, have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis.

    After intramuscular vaccination with the diphtheria/tetanus toxoids; pertussis vaccine, DTP, apnea has been observed in some infants born prematurely. For infants born prematurely, consider the infant's medical status and the potential benefits and possible risks of vaccination when deciding when to administer an intramuscular vaccine such as DTP. Cyanosis and cough have been reported during post-marketing observation with DTaP. Asthma and bronchospasm with hypoxia occurred within 30 days of dose receipt in 0.1% and 0.2% of children, respectively, who received DTaP and other vaccines during clinical studies.

    Among recipients of diphtheria/tetanus toxoids; pertussis vaccine, DTP during clinical studies, fever of at least 101 degrees F occurred in 0.4% to 5.6% of infants and children who specifically received DTaP. Fever typically occurred during the first 3 days post-immunization. Fever higher than 100.4 degrees F occurred in 3.8% to 25% of infants and children who received DTaP. Fever of 105 degrees F or higher is rare, reported in 0.08% of infants who received DTaP during an open-label non-controlled trial that evaluated the DTaP primary 3-dose immunization series. Fever of 40.5 degrees C (105 degrees F) or higher not attributable to other causes and occurring within 48 hours of administration is thought to be related to the pertussis component of the vaccine. Of adolescents who received Tdap during clinical studies, 2.3% to 13.5% had fever of at least 99.5 degrees F, and 5% had fever of 100.4 degrees F or higher, which was significantly greater than those in a comparative group that received Td (1.4%). Febrile convulsions have been reported during postmarketing surveillance. Instruct patients to report any signs and symptoms of a fever to their health care provider.


    Seizures have rarely been reported after DTP immunization, which, like high fever, may be related to the pertussis component of the vaccine. Of 4,696 infants who received DTaP during a clinical efficacy trial, 1 experienced a seizure within 48 hours following vaccination. In a German safety study, afebrile seizures occurring within 7 days following DTaP administration were reported at a rate of 0.13/1,000 doses (66,867 doses administered as a 3 dose primary series). During a US study in which children (n = 1,454) received 4 doses of DTaP, 0.3% of children experienced a seizure within 60 days following any dose of the vaccine. One infant experienced an afebrile seizure with apnea on the day of the first vaccination. Seizures are more likely to occur in children with a history of seizures or a family history of seizures. Among infants and children who received diphtheria/tetanus toxoids; pertussis vaccine, DTP during clinical studies, 0% to 35.3% experienced irritability, 5.9% to 19.3% experienced fussiness, 0.2% to 2.5% experienced inconsolable crying (defined as 1 hour or more), and 1% to 2.4% experienced high pitched or unusual crying. Worldwide voluntary reports of serious adverse events with suspected causal connection received for DTP since market introduction include convulsions, depressed level of consciousness, febrile convulsion, hypotonia, hypotonic-hyporesponsive episode, and screaming. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Hypotonic-hyporesponsive episodes are rare, observed in 0.04% of children during 48 hours post-vaccination in an open-label study. Hypotonic-hyporesponsive episodes within 48 hours of administration or persistent, inconsolable crying for 3 hours or more (or high-pitched unusual screaming) occurring within 48 hours may be related to the pertussis component of the vaccine. Instruct patients to report any signs and symptoms of a fever or a systemic reaction. Pediatric patients experiencing any serious reaction after DTaP or Tdap administration should be evaluated for the appropriateness of continuing immunization versus completing immunization with DT or Td toxoids.


    During clinical safety studies with diphtheria/tetanus toxoids; pertussis vaccine, DTP, body aches and muscle weakness occurred in 30.4% of adolescents within 1 week after Tdap administration. Chills occurred in 15.1% of adolescents given Tdap. Arthralgia, or sore/swollen joints, was reported in 11.3% to 17.9% of adolescents; joint swelling had a mean duration of 2 days. Malaise (33% to 38%) and myalgia (58% to 61%) were also commonly reported in adult patients after a second dose of Tdap. Myositis, muscle spasms, back pain, and myalgia have also been noted during postmarketing surveillance.

    Idiopathic thrombocytopenic purpura (ITP) was reported within 30 days of DTaP receipt in 0.1% of children following a fifth consecutive dose of DTaP vaccine. ITP and thrombocytopenia have also been observed during postmarketing experience with diphtheria/tetanus toxoids; pertussis vaccine, DTP.

    Arthus reaction is occasionally reported following administration of diphtheria/tetanus toxoids; pertussis vaccine, DTP. Arthus-type hypersensitivity reactions may be associated with high levels of circulating antitoxin in persons who have had overly frequent injections of tetanus toxoid. Do not administer the DTP vaccine more frequently than recommended. The local, type III, immune complex mediated hypersensitivity reaction is usually self-limiting, and patients may experience redness at the injection site, which usually appears within 2 to 8 hours of vaccine administration. Persons who experienced Arthus-type hypersensitivity reactions or a temperature higher than 103 degrees F (higher than 39.4 degrees C) after a prior dose of tetanus toxoid usually have high serum tetanus antitoxin concentrations and should not be given routine or emergency doses of DTP vaccine more frequently than every 10 years, even if they have a wound that is neither clean nor minor.

    Diphtheria/tetanus toxoids; pertussis vaccine, DTP is generally well tolerated. The most common adverse reactions are local reactions (i.e., injection site reaction) consisting of pain, erythema, swelling, or tenderness. Among DTaP recipients in clinical studies, 2.3% to 53.5% experienced pain. Moderate to severe pain (defined as spontaneously painful injection areas, crying when injected limb moved, protesting to touch, or prevention of normal activities) occurred in 0.6% to 20.5% of infants and children given DTaP. DTaP was associated with local erythema (0.3% to 59.8%), tenderness (6.7% to 61.5%), and swelling (0.9% to 61.4%) during clinical safety studies. Increases in limb circumference (mid thigh or arm) were reported in up to 38.3% of patients. A retrospective study that examined the occurrence of medically attended local reactions (e.g., limb swelling, cellulitis, limb pain) in a cohort of children 1 to 6 years who received 91,510 DTaP vaccines found reactions on the thigh and arm occurred at rates of 25.3 and 66.8 per 10,000 vaccinations, respectively. Children ages 12 to 35 months had a significantly higher risk of medically attended local reactions when given DTaP in the arm vs. the thigh (RR 1.88, 95% CI 1.34 to 2.65, p less than 0.001); older children also had increased risk with arm administration compared to thigh (RR 1.41, 95% CI 0.84 to 2.34) but the difference was not statistically significant. These results support current guidelines to administer IM DTaP vaccinations in the thigh for children 12 to 35 months of age. Local reactions to Tdap in children and adolescents are similar to those observed with DTaP, with pain (47.8% to 80%), erythema (17.9% to 47.4%), and swelling (12% to 38.9%) reported during clinical studies. Moderate to severe pain (defined as pain that was spontaneously painful, interfered with activities, necessitated medical care or absenteeism, or was incapacitating) occurred in 1.5% to 18% of children and adolescents given Tdap. Increases in arm circumference were reported in up to 28.3% of adolescents. Local reactions reported during post-marketing use include injection site induration or mass, cellulitis, abscess or sterile abscess, rash, pruritis, warmth, bruising, and nodules. A nodule may be palpable at the injection site for several weeks, as these have been reported following the use of adsorbed products. Large injection site reactions (more than 50 mm) and extensive limb swelling (including joints) have been observed. Many injection site reactions occurred within 3 days of immunization during clinical studies and resolved within 5 days without sequelae. Local reactions are usually self-limiting and do not require therapy; however, persistent reactions that require medical care have occurred.

    Anorexia was noted in 0% to 22.2% of infants and children who received DTaP during clinical studies. Across all clinical studies of diphtheria/tetanus toxoids; pertussis vaccine, DTP (DTaP and Tdap) that included infants, children, and adolescents, 0% to 7.4% had vomiting and 0.8% to 10.3% had diarrhea. A total of 26% of patients who received Tdap reported some type of GI adverse reaction within 2 weeks of vaccine receipt, which included nausea, vomiting, diarrhea, or abdominal pain. Nausea was specifically reported in 13.3% of adolescents who received Tdap. Instruct patients to report any signs and symptoms of a systemic reaction. One case of insulin dependent diabetes mellitus was diagnosed during clinical studies in an adolescent 20 days following administration of Tdap.

    A causal relationship between tetanus toxoid receipt and both brachial neuritis and Guillain-Barre syndrome appears to exist. If Guillain-Barre syndrome occurs within 6 weeks of receipt of a prior vaccine that contained tetanus toxoid, base the decision to give any vaccine containing tetanus toxoid such as diphtheria/tetanus toxoids; pertussis vaccine, DTP on careful consideration of the potential benefits and possible risks, as the risk for Guillain-Barre syndrome may be increased. When a decision is made to withhold tetanus toxoid, administer other available vaccines, as indicated. Encephalopathy such as coma, decreased level of consciousness, or prolonged seizures within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine. Whole cell DTP was associated with acute encephalopathy in children. There are insufficient data at this time to determine if there is a causal association of encephalopathy with vaccines such as DTaP or Tdap that contain acellular DTP vaccines, or if the incidence is different from that of whole cell DTP. The results of the National Childhood Encephalopathy Study (NCES) in England concluded that children 2 to 35 months of age who had histories of acute neurologic disorders were more likely to have received whole cell DTP immunization within 7 days of the onset of the neurologic illness than controls. The incidence of these events is estimated at 1 per every 140,000 children vaccinated with whole cell DTP. A follow-up study of the NCES 10 years later concluded that these affected cases were also more likely to have experienced chronic neurologic sequelae. The Advisory Committee on Immunization Practices (ACIP) evaluated the follow-up study and concluded that the data are insufficient to determine whether whole cell DTP administration before the acute neurologic event influenced the potential for chronic neurologic dysfunction 10 years later. Subsequent studies have not been able to prove a causal relationship. Postmarketing, encephalitis, encephalopathy, Guillain-Barre syndrome, brachial neuritis, paresthesias, hypoesthesia, facial palsy, myelitis, autism, demyelinating diseases of the CNS, peripheral neuropathy, and cranial mononeuropathy have all been observed following immunization with DTP vaccines. One case of severe migraine with unilateral facial paralysis and 1 diagnosis of nerve compression in the neck and arm have been reported in adults following Tdap administration. Other neurological reactions to DTP vaccines reported during clinical studies include headache, which was observed in 17% to 44% of adolescents who received Tdap.

    Syncope has been reported during postmarketing experience with diphtheria/tetanus toxoids; pertussis vaccines. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Have procedures in place to avoid falling injury and to restore cerebral perfusion after syncope.

    Infection has been observed during clinical studies with diphtheria/tetanus toxoids; pertussis vaccine, DTP, including bronchiolitis, which was reported in 1.9% of children. Pneumonia and cellulitis that occurred within 30 days of vaccination were reported in 0.1% of children who received a 5th dose in the DTaP series. Bronchitis, respiratory tract infections, myocarditis, meningitis, sepsis, pertussis (post-dose 1), and otalgia have been reported. Lymphadenopathy was reported in 6.6% of adolescents who received Tdap during clinical studies, and it has also been observed with the use of DTaP vaccines. Three deaths related to invasive bacterial infections were reported with DTaP use during clinical studies; however, further investigation revealed no evidence for a causal relationship between DTaP vaccination and altered bacterial resistance.

    Fatigue was among the most common adverse reactions to the diphtheria/tetanus toxoids; pertussis vaccine, DTP. In adolescents who received Tdap during clinical studies, fatigue or tiredness was reported in 20.4% to 37%. Among recipients of DTaP, 5.6% to 41.5% had drowsiness. Decreased activity and lethargy occurred within 3 days after DTaP receipt in 12.6% to 51.1% of infants and children. Instruct patients to report any signs or symptoms of a systemic reaction.

    Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of diphtheria/tetanus toxoids; pertussis vaccine, DTP has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

    In some premature neonates, apnea after intramuscular vaccination has been observed. Consider the infant's medical status and the vaccine's potential benefits and possible risks when deciding when to administer an intramuscular vaccine such as diphtheria/tetanus toxoids; pertussis vaccine, DTP to infants born prematurely.

    Diphtheria/tetanus toxoids; pertussis vaccine, DTP is only indicated for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration.

    Careful consideration of the potential risks and benefits of diphtheria/tetanus toxoids; pertussis vaccine, DTP is needed if a patient had Guillain-Barre syndrome within 6 weeks of receipt of a prior vaccine that contained tetanus toxoid. The Institute of Medicine (IOM) has found evidence suggesting a causal relationship between tetanus toxoid receipt and brachial neuritis and Guillain-Barre syndrome.

    Diphtheria/tetanus toxoids; pertussis vaccine, DTP is contraindicated in patients who have had an immediate anaphylactic reaction, temporally associated with a previous dose of this vaccine or any of its components. DTP vaccines should also be used with caution in patients with latex hypersensitivity; some products contain latex. Dry natural latex rubber is contained in the tip cap of the prefilled syringes of Infanrix, Adacel, and Boostrix. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. Epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis should be immediately available in the event of a serious allergic reaction to the vaccine. If immunizations are to be considered in a patient with a history of a severe allergic reaction to the vaccine or a component of the vaccine, referral of the potential vaccine recipient to an allergist may be appropriate. Patients who have experienced an Arthus-type hypersensitivity reaction after a tetanus toxoid dose should not be given Tdap as an emergency or routine booster vaccination until 10 years after the last dose of a tetanus toxoid containing vaccine.

    Diphtheria/tetanus toxoids; pertussis vaccine, DTP is contraindicated in patients who have experienced encephalopathy (coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another cause. The DTaP vaccine is also contraindicated in patients with a progressive neurological disease including infantile spasms, an uncontrolled seizure disorder, or progressive encephalopathy; do not administer the pertussis vaccine to patients with these conditions until a treatment regimen has been established and the condition has stabilized. Tdap vaccines should be used with caution in patients progressive or unstable neurologic conditions, which may also include uncontrolled seizure disorders and acute encephalopathic conditions, as well as cerebrovascular events (i.e., stroke); vaccination may be deferred until the condition stabilizes. The Advisory Committee on Immunization Practices (ACIP) recognizes that immunization with a vaccine containing DTaP in infants or children with stable neurological disease, including well-controlled seizures, may not be contraindicated. For children at higher risk of seizures than the general population, the ACIP recommends that acetaminophen or ibuprofen be administered at the time of vaccination and for 24 hours after to reduce the possibility of postvaccination pyrexia.

    If any of the following occur in temporal relation to administration of a vaccine containing pertussis (specifically DTaP vaccines for use in infants and children < 7 years), the potential benefits and possible risks should be carefully considered when deciding to administer subsequent doses of diphtheria/tetanus toxoids; pertussis vaccine, DTP or other pertussis-containing vaccines: fever of >= 40.5 degrees C (105 degrees F) 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; and convulsions with or without fever occurring within 3 days. If a decision is made to withhold the pertussis component, immunization with DT should continue according to recommended immunization schedules. The decision to administer or to delay vaccination because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during the course of a moderate or severe acute febrile illness and administered after the acute phase of illness has resolved. All vaccines can be given to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness.

    The diphtheria/tetanus toxoids; pertussis vaccine, DTP is indicated for intramuscular administration. Therefore, the vaccine should be given cautiously to persons receiving anticoagulant therapy. Also, patients with thrombocytopenia, coagulopathy (e.g., hemophilia), other bleeding disorders, or vitamin K deficiency should be monitored closely for bleeding at IM injection sites. Steps to avoid hematoma are recommended.

    Patients with significant immunosuppression may not have an adequate antibody response to diphtheria/tetanus toxoids; pertussis vaccine, DTP. Immunosuppressed persons may include patients with human immunodeficiency virus (HIV) infection; severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.

    Syncope has been reported after vaccination with diphtheria/tetanus toxoids; pertussis vaccines. These events may be accompanied by transient visual disturbance, paresthesia, and tonic-clonic limb movements. Prior to administration of the vaccine, ensure procedures are in place to prevent falls and restore cerebral perfusion.

    Safety and efficacy of the diphtheria/tetanus toxoids; pertussis vaccine (DTP) have not been established in neonates and infants < 6 weeks of age.

    Description: Vaccination against diphtheria, tetanus, and pertussis is accomplished by using combination products that contain various pertussis antigens (isolated from Bordetella pertussis) in combination with diphtheria toxoid (isolated from Corynebacterium diphtheriae) and tetanus toxoid (isolated from Clostridium tetani). The first combination DTP vaccines contained whole cell pertussis; however, in 1997, adverse reactions ranging from local adverse reactions to severe systemic events associated with the use of whole-cell DTP vaccines led to recommendations by the Advisory Committee on Immunization Practices (ACIP) that acellular pertussis vaccines (DTaP), which contain purified antigenic components, be used for routine childhood vaccination in the United States. Vaccination with DTaP is indicated for infants and children from 6 weeks through 6 years of age, and vaccination with tetanus toxoid and reduced diphtheria toxoid and acellular pertussis (Tdap) is recommended for older children and adolescents. The vaccines contain varying amounts of inactivated diphtheria and tetanus toxins and different combinations of pertussis antigens, which may include detoxified pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin, and fimbriae types 2 and 3. DTaP vaccines (Daptacel and Infanrix) are FDA approved for use in infants as young as 6 weeks; ideally, immunization should occur at 2, 4, 6, 15-18 months, and 4-6 years. Two Tdap vaccines (Adacel and Boostrix) are FDA approved for use in children as young as 10 years of age.

    General dosing information

    Recommended childhood immunization schedule:
    -Diphtheria, tetanus, and acellular pertussis vaccine (DTP): 5-dose series at 2, 4, 6, 15 to 18 months and 4 to 6 years.
    -Tetanus, diphtheria, and acellular pertussis vaccine (Tdap): 1 dose at 11 to 12 years.
    -Consult CDC Immunization Schedules for catch-up schedules and special populations.

    Additional information:
    -It is recommended that the same brand of DTaP vaccine be given for the entire immunization series because safety and efficacy data regarding interchangeability are not available. No data are available regarding the use of Tdap for the primary series or the completion of the series.
    -Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with DTaP vaccine. There is no need to start the primary series over again regardless of the time between doses.
    -If any recommended dose of pertussis vaccine cannot be given, DT or Td should be given as needed to complete the primary series or subsequent booster immunizations according to current immunization schedules.
    -If tetanus prophylaxis in wound management is needed, Tdap (Adacel) may be substituted for Td in children and adolescents 10 years and older if at least 5 years have elapsed since previous receipt of a tetanus toxoid-containing vaccine. Boostrix may be substituted for Td in children and adolescents 10 years or older if the patient has not previously received Tdap.
    -Immunize premature infants according to their chronological age, regardless of birth weight.

    For diphtheria prophylaxis, tetanus prophylaxis, and pertussis prophylaxis:
    Intramuscular dosage (Daptacel, Infanrix, DTaP):
    Infants and Children 6 weeks to 6 years: 0.5 mL IM for 3 doses at intervals of 4 to 8 weeks (preferably 8 weeks) for Infanrix or intervals of 6 to 8 weeks for Daptacel, ideally given at 2, 4, and 6 months of age. Although the first dose is usually at 2 months of age, it may be given as early as 6 weeks; the vaccine may be used up to the seventh birthday. A fourth dose is recommended at 15 to 20 months with an interval between the third and fourth dose of at least 6 months. If a fourth dose is inadvertently administered early, but is administered at least 4 months, but less than 6 months, after the third dose, it need not be replaced. A fifth dose is recommended at 4 to 6 years of age, prior to the child entering school. A fifth dose is not necessary if the fourth dose was given at age 4 years or older.
    Intramuscular dosage (Boostrix, Tdap):
    Children 7 to 9 years*: Safety and efficacy have not been established. A single dose of Tdap is recommended for children 7 to 10 years old who do not have a contraindication for pertussis vaccine and who are not fully vaccinated against pertussis, which is defined as 5 doses of DTaP, 4 doses if the fourth dose was administered on or after the fourth birthday, or an unknown immunization history. Further, a dose of Tdap is recommended as the first of a 3-dose vaccine regimen containing tetanus and diphtheria toxoids for children 7 to 10 years who were never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status.
    Children 10 years: 0.5 mL IM. A single dose of Tdap is recommended for children 7 to 10 years old who do not have a contraindication for pertussis vaccine and who are not fully vaccinated against pertussis, which is defined as 5 doses of DTaP, 4 doses if the fourth dose was administered on or after the fourth birthday, or an unknown immunization history. Further, a dose of Tdap is recommended as the first of a 3-dose vaccine regimen containing tetanus and diphtheria toxoids for children 7 to 10 years who were never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status.
    Children and Adolescents 11 to 17 years: 0.5 mL IM. Give 1 dose of Tdap to patients at 11 to 12 years of age; Td or Tdap booster needed every 10 years thereafter. Give 1 dose of Tdap to patients 13 to 17 years of age who have not received a dose and to pregnant adolescents during each pregnancy (preferably during the early part of gestational weeks 27 through 36). Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine. Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
    Intramuscular dosage (Adacel, Tdap):
    Children 7 to 9 years*: Safety and efficacy have not been established. A single dose of Tdap is recommended for children 7 to 10 years old who do not have a contraindication for pertussis vaccine and who are not fully vaccinated against pertussis, which is defined as 5 doses of DTaP, 4 doses if the fourth dose was administered on or after the fourth birthday, or an unknown immunization history. Further, a dose of Tdap is recommended as the first of a 3-dose vaccine regimen containing tetanus and diphtheria toxoids for children 7 to 10 years who were never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status.
    Children 10 years: 0.5 mL IM. A single dose of Tdap is recommended for children 7 to 10 years old who do not have a contraindication for pertussis vaccine and who are not fully vaccinated against pertussis, which is defined as 5 doses of DTaP, 4 doses if the fourth dose was administered on or after the fourth birthday, or an unknown immunization history. Further, a dose of Tdap is recommended as the first of a 3-dose vaccine regimen containing tetanus and diphtheria toxoids for children 7 to 10 years who were never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status.
    Children and Adolescents 11 to 17 years: 0.5 mL IM. Give 1 dose of Tdap to patients 11 to 12 years of age; Td or Tdap booster doses are then needed every 10 years thereafter. Patients 13 to 17 years of age who have not received Tdap should receive a dose. Give 1 dose of Tdap to pregnant adolescents during each pregnancy (preferably during the early part of gestational weeks 27 through 36). Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine. If a serious Arthus-type hypersensitivity reaction occurred after tetanus toxoid receipt, at least 10 years should elapse before Tdap administration.
    Intramuscular dosage (whole-cell pertussis DTP, Tri-Immunol):
    Infants and Children 2 months to 6 years: NOTE: This product is not commercially available in the U.S. 0.5 mL IM at intervals of 4 to 8 weeks for 3 doses beginning at 2 months of age. A fourth dose is recommended 6 to 12 months after the third dose, and a fifth dose is recommended at 4 to 6 years of age prior to the child entering school. A fifth dose is not necessary if the fourth dose was given at age 4 years or older. The vaccine may be used up to the seventh birthday.
    -for prophylaxis against diphtheria and tetanus for patients with large, contaminated wounds who also need the pertussis component:
    Intramuscular dosage (Adacel, Boostrix, Tdap):
    Children and Adolescents 10 to 17 years: 0.5 mL IM. A single dose of Tdap is preferred to Td if patients have not previously received Tdap. If immunization history is unknown or less than 3 doses of a tetanus toxoid vaccine have previously been given, give vaccine for clean, minor wounds or other severe or contaminated wounds. If 3 doses or more of a tetanus toxoid-containing vaccine have been given, give vaccine for clean, minor wounds if 10 years or more have elapsed since the last tetanus toxoid-containing vaccine, or for other severe or contaminated wounds if 5 years or more have elapsed since the last tetanus toxoid-containing vaccine. Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.
    Children 7 to 9 years*: 0.5 mL IM. A single dose of Tdap is preferred to Td if patients have not previously received Tdap. If immunization history is unknown or less than 3 doses of a tetanus toxoid vaccine have previously been given, give vaccine for clean, minor wounds or other severe or contaminated wounds. If 3 doses or more of a tetanus toxoid-containing vaccine have been given, give vaccine for clean, minor wounds if 10 years or more have elapsed since the last tetanus toxoid-containing vaccine, or for other severe or contaminated wounds if 5 years or more have elapsed since the last tetanus toxoid-containing vaccine.

    Maximum Dosage Limits:
    -Neonates
    Use not recommended.
    -Infants
    younger than 6 weeks: Use not recommended.
    6 weeks and older: 0.5 mL/dose IM of DTaP (Daptacel or Infanrix). Do not use Tdap (Boostrix or Adacel); safety and efficacy have not been established in this age group.
    -Children
    1 to 6 years: 0.5 mL/dose IM of DTaP (Daptacel or Infanrix). Do not use Tdap (Boostrix or Adacel); safety and efficacy have not been established in this age group.
    7 to 9 years: 0.5 mL/dose IM of Tdap (Boostrix or Adacel) may be used; however, Tdap and DTaP vaccines are not FDA-approved in this age group.
    10 to 12 years: 0.5 mL/dose IM of Tdap (Boostrix or Adacel). Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.
    -Adolescents
    0.5 mL/dose IM of Tdap (Boostrix or Adacel). Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.

    Patients with Hepatic Impairment Dosing
    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing
    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. However, consult current immunization schedules for recommended vaccines for use in young dialysis patients; the ACIP states that all routine vaccinations are likely effective in patients with chronic renal disease.

    *non-FDA-approved indication

    Monograph content under development

    Mechanism of Action: Diphtheria/tetanus toxoids; pertussis vaccine, DTP confers immunity against the bacteria that cause diphtheria, tetanus, and pertussis (whooping cough).

    Diphtheria Toxoid: Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, an extracellular protein metabolite of toxogenic strains of C. diphtheriae. Diphtheria toxoid induces the production of neutralizing antibodies against the exotoxin. A serum diphtheria antitoxin concentration of at least 0.1 International Units/ml is considered protective.

    Tetanus Toxoid: Exotoxin release by C. tetani causes the neuromuscular dysfunction associated with tetanus. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin. A serum tetanus antitoxin concentration of at least 0.1 International Units/ml is considered protective.

    Acellular Pertussis Vaccine: Pertussis, or whooping cough, is a highly communicable disease of the respiratory tract caused by Bordetella pertussis infection. The acellular pertussis vaccine contains different pertussis antigens (e.g., filamentous hemagglutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components. A serological concentration indicative of protection against pertussis has not been established.

    Pharmacokinetics: DTP vaccines are administered intramuscularly. The pharmacokinetics of these vaccines are not well defined.


    -Special Populations
    Pediatrics
    Infants and Children > 6 weeks to < 7 years
    The immunogenicity of DTaP vaccines was evaluated in infants and children who received Daptacel at 2, 4, 6, and 15-17 months of age. Diphtheria antitoxin concentrations >= 0.1 International Units/ml were detected in 98.5% of infants (n = 1099) after 3 doses and diphtheria antitoxin concentrations were >= 1 International Unit in 96.5% of children (n = 659) after 4 doses. Similarly, tetanus antitoxin concentrations >= 0.1 International Units/ml were detected in 100% of infants (n = 1037) after 3 doses and tetanus antitoxin concentrations were >= 1 International Unit in 98.8% of children (n = 681) after 4 doses. Immunogenicity studies that evaluated the ability of infant sera to neutralize diphtheria and tetanus toxins 1 month after a 3-dose primary series of Infanrix demonstrated positive results, and 100% of infants achieved diphtheria and tetanus antitoxin concentrations >= 0.01 International Units/ml. Although a serologic correlate indicative of pertussis protection is not established, antibody responses to pertussis antigens were associated with clinical efficacy.

    Children >= 10 years and Adolescents
    Increased tetanus and diphtheria antitoxin concentrations are obtained after a single booster vaccination with Boostrix or Adacel (Tdap) in patients who receive the recommended primary vaccination series in childhood. Of over 2,400 Boostrix recipients 10-18 years of age, 89.7% had at least a 4-fold increase from the pre-vaccination tetanus antitoxin concentration, and 90.6% had at least a 4-fold increase from the pre-vaccination diphtheria antitoxin concentration 1 month after booster vaccine receipt. Similar responses were obtained from 527 Adacel recipients 11-17 years old (91.7% and 95.1%, respectively). As compared with either Adacel or Boostrix, a single Td vaccination yielded similar antibody responses. Increased serum antibodies to pertussis antigens also occurred after Boostrix or Adacel receipt. At least a 2-fold increase from the pre-vaccination pertussis antibody concentration occurred for each of the 3 pertussis antigens in 84.5% of the patients who received Boostrix. Furthermore, the antibody concentrations 1 month after Boostrix receipt were non-inferior to concentrations achieved after a primary vaccination series with Infanrix in infants. Of patients who received Adacel, at least a 2-fold increase from the pre-vaccination pertussis antibody concentration occurred for each of the 4 pertussis antigens in 85.6% of 524 patients 11-17 years old. Antibody concentrations to all 4 pertussis antigens 1 month after Adacel receipt were greater than concentrations achieved after a primary vaccination series with Daptacel in infants.

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