Adacel

Vaccine Combinations with a Tetanus Component

 
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. The action is 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.
If a prior DTP dose has been given, question the parent, guardian, or patient about any symptoms or signs of an adverse reaction after the previous dose. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated.
The health care professional should have immediate availability of epinephrine 1 mg/mL injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.

DTaP and Tdap are administered intramuscularly; do not give intravenously or subcutaneously.
Do not administer fractional doses (i.e., doses < 0.5 mL).
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Preparation:
Shake vial vigorously just before withdrawing dose (use aseptic technique) to ensure a uniform, cloudy suspension. If the vaccine cannot be resuspended, discard it.
Do not mix Daptacel, Tri-Immunol, Boostrix, Adacel, or Infanrix with any other vaccine.[30295] [31250] [31290] [44533]
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 before Daptacel. Clinical trials found a reduced meningococcal antibody response when Menactra was administered one month after Daptacel.[30295]
Storage of unopened vials:
Manufacturer recommendations: Store refrigerated at 2 to 8 degrees C (36 to 46 degrees F); do not freeze.[30295] [31250] [31290] [44533]
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.[58514] 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 injection:
Use a separate syringe and needle for each person receiving DTaP or Tdap.
Clean skin over the injection site with a suitable cleansing agent before administration.
The preferred injection sites are the anterolateral aspect of the thigh (particularly for infants) and 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.

angioedema / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
seizures / Delayed / Incidence not known
Guillain-Barre syndrome / Delayed / Incidence not known
myelitis / Delayed / Incidence not known
apnea / Delayed / Incidence not known
bronchospasm / Rapid / Incidence not known
cyanosis / Early / Incidence not known
myocarditis / Delayed / Incidence not known

erythema / Early / 6.0-50.0
myasthenia / Delayed / 22.0-30.0
lymphadenopathy / Delayed / 7.0-7.0
hypotension / Rapid / Incidence not known
dyspnea / Early / Incidence not known
edema / Delayed / Incidence not known
hypotonia / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
encephalopathy / Delayed / Incidence not known
neuritis / Delayed / Incidence not known
hypoxia / Early / Incidence not known
thrombocytopenia / Delayed / Incidence not known
Arthus reaction / Early / Incidence not known
meningitis / Delayed / Incidence not known

injection site reaction / Rapid / 4.0-88.0
irritability / Delayed / 23.0-76.0
myalgia / Early / 58.0-61.0
drowsiness / Early / 18.0-54.0
headache / Early / 12.0-53.0
lethargy / Early / 13.0-51.0
malaise / Early / 33.0-38.0
fatigue / Early / 12.0-37.0
fever / Early / 1.0-30.0
anorexia / Delayed / 8.0-28.0
arthralgia / Delayed / 9.0-18.0
chills / Rapid / 8.0-15.0
inconsolable crying / Delayed / 2.0-14.0
nausea / Early / 9.0-13.0
diarrhea / Early / 10.0-10.0
vomiting / Early / 3.0-7.0
rash / Early / 2.0-3.0
infection / Delayed / 0-2.0
maculopapular rash / Early / Incidence not known
purpura / Delayed / Incidence not known
urticaria / Rapid / Incidence not known
pruritus / Rapid / Incidence not known
hypoesthesia / Delayed / Incidence not known
paresthesias / Delayed / Incidence not known
cough / Delayed / Incidence not known
abdominal pain / Early / Incidence not known
syncope / Early / Incidence not known
back pain / Delayed / Incidence not known
weakness / Early / Incidence not known
otalgia / Early / Incidence not known

Adacel, Boostrix, Daptacel, Infanrix

Rx

Vaccine that contains various pertussis antigens, diphtheria toxoid, and tetanus toxoid
Used to help protect individuals from pertussis, diphtheria, and tetanus
Encephalopathy, coma, decreased level of consciousness, or prolonged seizures within 7 days of a dose that is not attributable to another cause is a contraindication to administration

0.5 mL IM.[31250] [31290] 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. If a tetanus toxoid-containing vaccine is indicated for a pregnant woman, use Tdap. [64478] 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.[31250] [31290] [53042]

0.5 mL IM.[31250] 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.[31250] [53042]

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.

0.5 mL IM. If 3 doses or more of a tetanus toxoid-containing vaccine have been given, give vaccine for all wounds except clean, minor wounds if 5 years or more have elapsed since the last tetanus toxoid-containing vaccine.

0.5 mL IM for 3 doses at intervals of 6 to 8 weeks, ideally given at 2, 4, and 6 months of age. 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.

0.5 mL IM for 3 doses at intervals of 4 to 8 weeks (preferably 8 weeks), ideally given at 2, 4, and 6 months of age. 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.

0.5 mL IM.[31250] Use Td or Tdap for subsequent booster immunizations. A dose of Tdap is recommended instead of Td to replace 1 of the 10-year Td boosters if Tdap has not been previously received or if vaccine status is unknown. Tdap may be administered as an additional dose 9 years or more after the initial Tdap dose. Administration of Tdap as soon as feasible is advised for all postpartum women not vaccinated during pregnancy, close contacts of infants younger than 12 months of age, and health care personnel with direct patient contact. Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.[31250] [53026]

0.5 mL IM, 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.[31250] [53026]

0.5 mL IM.[31250] Give 1 dose of Tdap to patients at 11 to 12 years of age; Td or Tdap booster needed every 10 years thereafter.[31250] [64951] For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series.[53026] [64951]

0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Patients who receive Tdap at 10 years should not receive the routine dose at 11 to 12 years.[53026]

0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Patients 7 to 9 years who receive Tdap should also receive the routine dose at 11 to 12 years.[53026]

0.5 mL IM.[31290] Use Td or Tdap for subsequent booster immunizations.[64951] A dose of Tdap is recommended instead of Td to replace 1 of the 10-year Td boosters if Tdap has not been previously received or if vaccine status is unknown. Administration of Tdap as soon as feasible is advised for all pregnant women (preferably during the early part of gestational weeks 27 through 36), for all postpartum women not vaccinated during pregnancy, close contacts of infants 12 months and younger, and health care personnel with direct patient contact. Tdap can be administered regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.[46272] [53026] [64951]

0.5 mL IM, 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. [53026]

0.5 mL IM.[31290] Give 1 dose of Tdap to patients at 11 to 12 years of age; Td or Tdap booster needed every 10 years thereafter.[31290] [64951] For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Give 1 dose of Tdap to pregnant adolescents during each pregnancy (preferably during the early part of gestational weeks 27 through 36); administer regardless of the interval since the most recent tetanus or diphtheria-containing vaccine.[53026] [64951]

0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Patients who receive Tdap at 10 years should not receive the routine dose at 11 to 12 years.[53026]

0.5 mL IM. For patients never immunized against diphtheria, tetanus, or pertussis, with unknown immunization status, or not fully immunized, catch-up immunization is recommended. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. Patients 7 to 9 years who receive Tdap should also receive the routine dose at 11 to 12 years.[53026]

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.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

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.
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.
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.
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.
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.

Adacel/Boostrix/Daptacel/Infanrix Intramuscular Inj Susp

0.5 mL/dose IM for Tdap (Boostrix or Adacel). Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.

0.5 mL/dose IM for Boostrix; safety and efficacy have not been established for Adacel. Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.

0.5 mL/dose IM for Tdap (Boostrix or Adacel). Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.

10 to 12 years: 0.5 mL/dose IM for Tdap (Boostrix or Adacel). Do not use DTaP (Daptacel or Infanrix); safety and efficacy have not been established in this age group.
7 to 9 years: 0.5 mL/dose IM for Tdap (Boostrix or Adacel) may be used; however, Tdap and DTaP vaccines are not FDA-approved in this age group.
1 to 6 years: 0.5 mL/dose IM for DTaP (Infanrix or Daptacel). Do not use Tdap (Boostrix or Adacel); safety and efficacy have not been established in this age group.

6 weeks and older: 0.5 mL/dose IM for DTaP (Daptacel or Infanrix). Do not use Tdap (Boostrix or Adacel); safety and efficacy have not been established in this age group.
younger than 6 weeks: Use not recommended.

Use not recommended.

The pathologic sequelae of Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, an extracellular protein metabolite of toxogenic strains of C. diphtheriae. Diphtheria toxoid induces the production of antibodies against the exotoxin, which inactivate it, presumably by standard antibody-antigen interactions. Infection with C. diphtheriae does not necessarily confer immunity, and previously infected individuals should still receive toxoid.
 
Tetanus, the neuromuscular dysfunction associated with C. tetani infections, is caused by exotoxin elaboration. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin, thereby inactivating it. Natural immunity to C. tetani does not occur in the U.S., and even patients previously infected with C. tetani should receive the tetanus toxoid.
 
Bordetella pertussis has a variety of cellular components that contribute to the pathogenesis of whooping cough by mechanisms that are poorly understood. The various acellular vaccines contains different pertussis antigens (e.g., agglutinogen, filamentous hemaggutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components. Clinical studies suggest it has an efficacy of 79—93% in protecting against clinical pertussis after household exposure. In addition, pertussis occurring in vaccinees is typically less severe than pertussis in unimmunized patients.

DTP vaccines are administered intramuscularly. After 3 doses of DTP, 70% to 90% of recipients develop protective antibodies against B. pertussis. In patients receiving 4 doses of DTP, immunity has been shown to persist for 10 years or more. In those receiving 4 doses of DTP, immunity starts to decline 4 to 6 years after immunization, and fewer than 50% of recipients have protective antibodies against B. pertussis 10 years after immunization. Lifelong immunity occurs, however, most likely from subsequent B. pertussis infections.
 
The immunogenicity of Boostrix was compared with Adacel when administered as a single-dose booster to 2,284 adults, ages 19 to 64 years, who had not received a tetanus-diphtheria booster within 5 years. One month after a single dose, the anti-tetanus seroprotective rate (0.1 International Units/mL or more) of Boostrix was non-inferior to the seroprotective rate of Adacel (99.6% vs.100% respectively). Similarly, the anti-diphtheria seroprotective rate of Boostrix was also non-inferior to that of Adacel (98.2% vs. 98.6%). In addition, the pertussis antigen response was evaluated for Boostrix. The anti-pertussis exotoxin, anti-filamentous hemagglutinin antigen, and anti-pertactin antibody concentrations in adults 1 month after a single dose of Boostrix were non-inferior to those of infants after a primary vaccination series with Infanrix.[31250]

Safety data of Tdap from a randomized, controlled clinical trial of a non-U.S. formulation of Boostrix during the third trimester (341 pregnant patients received a non-U.S. formulation of Boostrix, 346 pregnant patients received placebo) did not reveal any vaccine-related adverse effects on pregnancy or on the fetus and/or newborn child. Safety data during the first and second trimester of pregnancy are not available. An assessment of U.S. pregnancy registry data from 2005 to 2022 included reports of Boostrix (n = 1,523) and Adacel administration (n = 1,236) prior to conception or during pregnancy. Of these, there were 256 reports (Boostrix) and 286 reports (Adacel) with known pregnancy outcomes. During the first trimester, 19 patients were exposed to Boostrix with no major birth defects reported. Additionally, no apparent birth defects were reported with 3 spontaneous abortions. Patients were exposed during the second trimester (n = 28) and third trimester (n = 199) with no major birth defects reported. Ten patients were exposed with unknown timing in pregnancy and no birth defects were reported. During the first trimester, 118 patients were exposed to Adacel with 1 congenital anomaly and 14 spontaneous abortions; 54 patients were exposed in the second trimester with 1 congenital anomaly; 114 patients were exposed in the third trimester with 2 congenital anomalies; and 76 patients were exposed at an unknown trimester with 1 congenital anomaly. An assessment of U.S. spontaneous reports and postmarketing data including 810 prospective reports of Boostrix exposure during pregnancy included 138 reports with known pregnancy outcomes. Seventeen patients were exposed to Boostrix during the first trimester with no major birth defects reported and 2 spontaneous abortions occurred with no apparent birth defects. Patients were exposed during the second trimester (n = 26) and third trimester (n = 92) with no major birth defects reported. Three patients were exposed with unknown timing in pregnancy and no birth defects were reported. Health care providers are encouraged to register pregnant patients by calling 1-888-452-9622 or visiting http://pregnancyregistry.gsk.com/boostrix.html for Boostrix and calling 1-800-822-2463 or visiting https://www.sanofipasteurpregnancyregistry.com for Adacel.[31250] [31290] Available data suggest infants of mothers who receive a Tdap vaccination may receive early protection against pertussis from Tdap-induced transplacental maternal antibodies. The half-life of transferred maternal pertussis antibodies is approximately 6 weeks.

There is no information on the excretion of DTP antigens or antibodies in breast milk or the effects on the breastfed infant or milk production.[31290] According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as DTaP and Tdap, 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.[43236] 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.[31290]