Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Inactivated Poliovirus Vaccine, IPV is a combination of 4 vaccines. It is administered intramuscularly and may be used for the fifth dose in the DTaP and the fourth dose in the IPV immunization series in children 4 to 6 years of age. Whole cell DTP (DTwP) was previously used in vaccines, but due to the potential association with acute encephalopathy in children, acellular DTP vaccines (DTaP) replaced DTwP in vaccines in the United States. The administration of combination vaccines such as Kinrix and Quadracel are believed to reduce cost and improve compliance to the recommended vaccination schedule by reducing the number of injections received per physician visit.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-Inform the patient or parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the parent or guardian before each immunization. This action is required by the National Childhood Vaccine Injury Act of 1986.
-Record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine in the patient's permanent record. These actions are required by the National Childhood Vaccine Injury Act of 1986.
-Epinephrine 1 mg/mL 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.
Route-Specific Administration
Injectable Administration
-Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is administered intramuscularly; do not give intravenously or subcutaneously.
-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.
-Prior to use, shake the vial or prefilled syringe vigorously to obtain a uniform white suspension.
-Do not mix with any other vaccine.
-A separate syringe and needle should be used for each person receiving a vaccine.
-Vials and prefilled syringes are for single use only and contain no preservatives; discard any unused portion.
Intramuscular Injection
-Quadracel vial: Use a sterile syringe and needle to withdraw suspension from vial.
-Kinrix/Quadracel prefilled syringe: Attach a sterile needle to the prefilled syringe.
-Inject into the deltoid muscle of the upper arm.
Among DTaP; IPV (Kinrix) recipients, 19.1% had drowsiness during clinical trials. Additionally, myalgia (53.8%), malaise (35%), and headache (15.6%) were reported in clinical trials of Quadracel. Anaphylactoid reactions, anaphylactic shock, angioedema, urticaria, pruritus, rash, dyspnea, somnolence, cyanosis, pallor, and lymphadenopathy have been observed through postmarketing surveillance. Other adverse events noted with DTP that may occur with DTaP; IPV include arthralgia, chills, lethargy, bronchospasm, maculopapular rash, somnolence, hypotension, myocarditis, and myositis. Instruct patients to report any signs and symptoms of a systemic reaction. Epinephrine 1 mg/mL 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.
Apnea has been noted postmarketing with the DTaP; IPV vaccine.
Fever of at least 99.5 degrees F was noted among 6% to 16% of DTaP; IPV recipients. Collapse or shock-like state (hypotonia with hyporesponsiveness), seizures with or without fever, listlessness, hypotonic hyporesponsive episode (HHE), and screaming have been noted postmarketing. Irritability has been noted with DTP and may occur with the DTaP; IPV vaccine. If any of the following events occur in temporal relation to receipt of a pertussis-containing vaccine, base the decision to give any pertussis-containing vaccine on careful consideration of the potential benefits and possible risks: collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours; seizures with or without fever within 3 days; persistent, inconsolable crying for 3 hours or more within 48 hours; or fever at least 40.5 degrees C (105 degrees F) not attributable to other causes and occurring within 48 hours of immunization. When a decision is made to withhold pertussis vaccination, administer other available vaccines, as indicated. Instruct patients to report any signs and symptoms of a fever or a systemic reaction. Seizures are more likely to occur in children with a history of seizures or a family history of seizures.
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 containing tetanus toxoid, base the decision to give any tetanus toxoid-containing vaccine including DTaP; IPV 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. Although not noted with the DTaP; IPV vaccine, the following adverse events have been noted with DTP or DT and may occur with DTaP; IPV: muscle weakness, paresthesias, hypoesthesia, facial palsy, peripheral neuropathy, muscle paralysis, and myelitis. Demyelinating diseases of the central nervous system, cranial mononeuropathies, and EEG disturbances with encephalopathy (with or without permanent intellectual and/or motor function impairment) have also been reported, but data are insufficient to accept or reject causality. Tetanus toxoid could be a possible etiology for these events.
An injection site reaction consisting of erythema, pain, and swelling is a common adverse reaction of DTaP; IPV vaccine. Among vaccine recipients, 57% to 77.4% had pain, 37% to 59.1% had erythema, and 26% to 40.2% had swelling at the injection site. Change in limb circumference has been reported in 36% to 68.1% of patients. During postmarketing surveillance, injection site vesicles, injection site reactions (including inflammation, mass, abscess, cellulitis, and edema), and large injection site reactions (more than 50 mm), including limb swelling which may extend from the injection site beyond one or both joints, have been observed.
Among DTaP; IPV vaccine (Kinrix) recipients, 15.5% had a loss of appetite (anorexia). Nausea, vomiting, and/or diarrhea may also occur, as they have been noted among DTP recipients. Instruct patients to report any signs and symptoms of a systemic reaction.
Syncope has been reported postmarketing with the DTaP; IPV vaccine. 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.
Thrombocytopenia has been noted postmarketing with the DTaP; IPV vaccine.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is only indicated for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration. Incorrect administration may result in inadequate immunity.
If Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, base the decision to give subsequent doses of any vaccine containing tetanus toxoid, including diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV on careful consideration of the potential benefits and possible risks.
Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is contraindicated in patients who have had serious hypersensitivity reactions or anaphylaxis associated with a previous dose of this vaccine or any of its components. This includes patients with neomycin hypersensitivity, polysorbate 80 hypersensitivity, and polymyxin hypersensitivity as the vaccine contains these components. As with any biologic product, take appropriate precautions to prevent allergic reactions. Epinephrine 1 mg/mL 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.
The tip caps of the Kinrix prefilled syringes contain natural rubber latex, therefore, administer this vaccine with caution to patients with a history of latex hypersensitivity or a condition with the potential for latex hypersensitivity (e.g., spina bifida). The plungers and Quadracel vial stoppers do NOT contain latex. Epinephrine 1 mg/mL 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.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is contraindicated in patients who have experienced encephalopathy (i.e., 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 vaccine is also contraindicated in patients with a progressive neurological disease, including infantile spasms, an uncontrolled seizure disorder, or progressive encephalopathy, until a treatment regimen has been established and the condition has stabilized. The ACIP recognizes that vaccination of infants or children with stable neurological disease, including well-controlled seizures, may not contraindicate immunization with a vaccine containing DTaP. Consideration of deferral of vaccination is recommended in unstable, deteriorating, or progressive neurologic disorders, and ACIP and AAP guidelines should be reviewed. If the decision to administer the vaccine is made, inform the parent or guardian of the potential risks.
If any of the following occur in temporal relation to administration of a vaccine containing pertussis (whole cell or acellular), the potential benefits and possible risks should be carefully considered when deciding to administer subsequent doses of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV or other pertussis-containing vaccine: fever of at least 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 at least 3 hours, occurring within 48 hours; and convulsions with or without fever occurring within 3 days.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is indicated for intramuscular administration. Therefore, give the vaccine cautiously to persons receiving anticoagulant therapy. Also, monitor patients with thrombocytopenia, coagulopathy (e.g., hemophilia), other bleeding disorders, or vitamin K deficiency 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 the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV. 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 (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.
Deferral of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV administration may be appropriate for a patient with a moderate or severe acute illness such as infection with or without fever. 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 administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Vaccinate persons with moderate or severe febrile illness as soon as they have recovered from the acute phase of the illness.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is not approved for use in individuals of childbearing age. Therefore, no data are available to assess vaccine-associated pregnancy risks. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial vaccines to pregnant women has not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm.
The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV is not approved for use in individuals of childbearing age. Therefore, no data are available on its use during breast-feeding to assess the impact of the vaccine on milk production, its presence in breast milk, or its effects on the breastfed infant. According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as Kinrix and Quadracel, pose no risk for nursing mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. While Kinrix and Quadracel are not approved for use during childbearing age, the individual vaccine components are and may be potential alternatives to consider during breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
General dosing information:
-A single dose of Kinrix may be used as the fifth dose in the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP vaccine series and the fourth dose in the inactivated poliovirus vaccine, IPV series in children 4 to 6 years of age whose previous DTaP vaccine doses have been with Infanrix and/or Pediarix for the first 3 doses and Infanrix for the fourth dose.
-A single dose of Quadracel may be used as a fifth dose in the DTaP vaccine series and as a fourth or fifth dose in the IPV vaccine series in children 4 to 6 years of age whose previous DTaP vaccine doses have been with Pentacel, Daptacel, and/or Vaxelis.
For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, and poliovirus prophylaxis:
Intramuscular dosage:
Children 4 to 6 years: 0.5 mL IM as a single dose.
Maximum Dosage Limits:
-Adults
Safety and efficacy have not been established.
-Geriatric
Safety and efficacy have not been established.
-Adolescents
Safety and efficacy have not been established.
-Children
6 to 12 years: Safety and efficacy have not been established.
4 to 6 years: 0.5 mL/dose IM.
1 to 4 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
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.
*non-FDA-approved indication
Albuterol; Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Betamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Bimekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticosteroids (systemic): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticotropin, ACTH: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Cortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deflazacort: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Dexamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hydrocortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methylprednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Prednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Prednisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Triamcinolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Vamorolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; inactivated poliovirus vaccine, IPV confers immunity against the bacteria that cause diphtheria, tetanus, pertussis (whooping cough), and polio.
-Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP: 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. Exotoxin release by Clostridium 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. 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.
-Inactivated poliovirus vaccine, IPV: Immunization with inactivated poliovirus vaccine (IPV) stimulates the immune system to produce neutralizing anti-poliovirus antibodies against each of the 3 poliovirus serotypes (Types 1, 2, and 3).
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Inactivated Poliovirus Vaccine, IPV is administered intramuscularly.
-Route-Specific Pharmacokinetics
Intramuscular Route
Kinrix
One month after administration of Kinrix (n = 787 to 851) to pediatric patients 4 to 6 years of age, patient responses to Kinrix were compared to responses to the administration of Infanrix and IPV (n = 237 to 262) administered as separate injections. The primary immunogenicity endpoints were anti-diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses, and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs); Kinrix was found to be non-inferior to the 2 separate injections in terms of booster responses to DTaP antigens and post-vaccination GMTs for anti-poliovirus antibodies. The following antibody responses were demonstrated: anti-diphtheria toxoid 0.1 International Units/mL or greater (100 % vs. 100% for all), anti-tetanus toxoid 0.1 International Units/mL or greater (100% vs. 100% for all), anti-pertussis response of 5 ELISA units/mL or greater in seronegative infants or at least maintenance of pre-vaccination concentration in seropositive infants (anti-PT [92.2% Kinrix vs. 92.6% Infanrix + IPV], anti-FHA [95.4% vs. 96.2%], and anti-pertactin [97.8% vs. 96.9%]), anti-polio Type 1 neutralizing antibody titer 1:8 or greater (99.9% vs. 100%), and anti-polio Types 2 and 3 neutralizing antibody titer 1:8 or greater (100% vs. 100% all). Booster responses to diphtheria, tetanus, and pertussis antigens and GMTs for poliovirus (Type 1, 2, and 3) were measured 1 month after administration of Kinrix with either MMR vaccine (n = 237) or MMRV vaccine (n = 239) in children 4 to 6 years of age. Booster responses after Kinrix administration with MMRV vaccine were non-inferior to immune responses after concomitant administration of Kinrix with MMR vaccine.
Quadracel
The immunogenicity of Quadracel (n = 253 to 262) was evaluated in pediatric patients aged 4 to 6 years who received the vaccine as the fifth dose in the diphtheria, tetanus, and pertussis vaccination series and the fourth or fifth dose in the inactivated poliovirus vaccination series, with comparison to individual vaccine components (administered as Daptacel + IPOL; n = 248 to 253). At 28 days after the last dose, immune responses to pertussis antigens (including pertussis toxin (PT), pertactin, and filamentous hemagglutinin (FHA)), diphtheria, tetanus, and poliovirus were non-inferior to those of the individual vaccine components. The following antibody responses were demonstrated: anti-diphtheria toxoid 0.1 International Units/mL or greater (100% Quadracel vs. 99.6% Daptacel + IPOL), anti-tetanus toxoid 0.1 International Units/mL or greater (100% vs. 99.2%), anti-PT booster response (95.2% vs. 89.9%), anti-FHA booster response (94.9% vs. 87.5%), anti-pertactin booster response (96.9% vs. 93.1%), anti-FIM booster response (97.2% vs. 92.4%), anti-polio Type 1 neutralizing antibody titer 1:8 or greater (100% vs. 99.6%), and anti-polio Types 2 and 3 neutralizing antibody titer 1:8 or greater (100% vs. 100% all). Booster response rates in both groups were similar.