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    Vaccine Combinations with a Tetanus Component

    DEA CLASS

    Rx

    DESCRIPTION

    Pentavalent vaccine for protection against pertussis, tetanus, diphtheria, Haemophilus influenzae type b, and polio in infants at least 6 weeks of age and children less than 5 years of age; consult current recommended immunization schedule from the Centers for Disease Control.

    COMMON BRAND NAMES

    Pentacel

    HOW SUPPLIED

    Pentacel Intramuscular Inj Pwd F/Susp
    Pentacel Intramuscular Inj Susp

    DOSAGE & INDICATIONS

    For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, Haemophilus influenzae type b prophylaxis, and poliovirus prophylaxis.
    Intramuscular dosage
    Infants at least 6 weeks of age and Children less than 5 years of age

    0.5 mL IM at 2, 4, 6, and 15 to 18 months of age (total of 4 doses). Four doses constitute a primary immunization course against pertussis, and three doses constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis; the fourth dose constitutes a booster vaccination against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis. NOTE: The recommended immunization schedule from the Centers for Disease Control calls for 4 doses of an inactivated poliovirus vaccine (IPV) at 2 months of age, 4 months of age, between 6 and 18 months of age, and 4 to 6 years of age; the recommended minimum interval between dose 1 and 2 and between dose 2 and 3 is at least 4 weeks and a minimum interval between dose 3 and 4 is 6 months. The final dose of a poliovirus vaccine series must be administered at age 4 to 6 years regardless of the number of previous doses. For example, a child who received 4 doses of Pentacel at 2, 4, 5, and 18 months of age needs an additional IPV dose at age 4 to 6 years. The minimum interval between dose 4 and 5 is 6 months.

    MAXIMUM DOSAGE

    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

    >=5 years: Safety and efficacy have not been established.
    < 5 years: 0.5 mL/dose IM.

    Infants

    >= 6 weeks: 0.5 mL/dose IM.
    < 6 weeks: Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

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

    Renal Impairment

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

    ADMINISTRATION

     
    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 Pentacel 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.
    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.
    The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.

    Injectable Administration

    Pentacel 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.
    Fractional doses (doses less than 0.5 mL) should not be given.

    Intramuscular Administration

    Preparation
    The package contains a vial of the DTaP-IPV component and a vial of lyophilized ActHIB vaccine component.
    After removing the "flip-off" caps, cleanse the DTaP-IPV and ActHIB vial stoppers with a suitable germicide.
    Gently shake the vial of the DTaP-IPV component, and withdraw the entire liquid content and inject into the vial of the lyophilized ActHIB vaccine component. Gently swirl the vial now containing Pentacel vaccine thoroughly until a cloudy, uniform, white to off-white (yellow tinge) suspension results. Do not administer if it appears otherwise. Also, do not administer the vaccine if it has been frozen. Immediately administer the vaccine after reconstitution; no preservative is present.
    Do not mix Pentacel with any other vaccine.
     
    Intramuscular Injection
    A separate syringe and needle should be used for each person receiving Pentacel.
    Before administration, clean skin over the injection site with a suitable cleansing agent.
    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.

    STORAGE

    Pentacel :
    - Do not use if product has been frozen
    - Protect from freezing
    - Store between 35 to 46 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    After administration of the ActHIB vaccine, antigenuria may be detected. Urine antigen detection may not have definite diagnostic value in suspected H influenzae type b disease within one week of Pentacel immunization.

    Children, geriatric, infants, neonates, premature neonates

    Pentacel is only indicated for use in infants and children 6 weeks through 4 years of age and thus, is not recommended for use in neonates, children at least 5 years of age, adolescents, adults, or geriatric patients. 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 Pentacel to infants born prematurely.

    Intraarterial administration, intravenous administration, subcutaneous administration

    Do not give Pentacel via intravenous administration or subcutaneous administration. The vaccine is for intramuscular (IM) use only. Take care to avoid injecting into a blood vessel (avoid intraarterial administration). Prior to administration, health care personnel should inform the patient, parent, guardian, or responsible adult of the vaccine's benefits and risks. This should include the provision of the vaccine information statement from the manufacturer. The responsible adult should report any adverse reaction following vaccine administration to the health care provider. The US Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 800—822—7967.

    Guillain-Barre syndrome

    Consideration of the risks and benefits of Pentacel vaccine receipt is needed if a patient had Guillain-Barre syndrome within 6 weeks of receipt of a vaccine that contained tetanus toxoid. A causal relationship between tetanus toxoid and brachial neuritis, Guillain-Barre syndrome, and anaphylaxis exists. If Guillain-Barre syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, base the decision to give Pentacel on careful consideration of the potential benefits and possible risks.

    Albumin hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity, polysorbate 80 hypersensitivity

    Patients with albumin hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity, or polysorbate 80 hypersensitivity may not be appropriate candidates for Pentacel vaccine receipt. Each 0.5 ml dose contains approximately 10 ppm by calculation of polysorbate 80, 50 ng or less of residual bovine serum albumin, less than 4 pg of neomycin, and less than 4 pg of polymyxin B sulfate. Immunization with Pentacel is contraindicated if a severe allergic reaction occurred after a previous dose of Pentacel vaccine, any ingredient of this vaccine, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, or H. influenzae type b vaccine. If a severe reaction occurred after Pentacel, none of the ingredients should be administered because of uncertainty as to which ingredient of the vaccine may be responsible. If immunizations are to be considered in a patient with a history of a severe allergic reaction to the vaccine or to a component of the vaccine, referral of the potential vaccine recipient to an allergist may be appropriate. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis.

    Encephalopathy, fever, neurological disease, seizure disorder, seizures

     Encephalopathy (coma, decreased level of consciousness, prolonged seizures) occurring within 7 days of a previous dose of a pertussis-containing vaccine and not attributable to another identifiable cause is a contraindication for receipt of a pertussis-containing vaccine including Pentacel. Furthermore, neurological disease such as progressive neurologic disorders, infantile spasms, uncontrolled epilepsy (seizures), or progressive encephalopathy are contraindications for the vaccine. However, once a treatment regimen has been established and the condition has stabilized, Pentacel receipt may occur if deemed appropriate by the physician after consideration of all relevant factors, risks, and benefits. Stable neurologic conditions such as cerebral palsy, well-controlled seizure disorder, or developmental delay are not contraindications for receipt of a pertussis-containing vaccine. A family history of seizures is also not a contraindication. If appropriate, acetaminophen or other appropriate antipyretic can be administered to infants and children with a history of previous seizures at the time of DTaP vaccination and every 4 hours for 24 hours thereafter to reduce the possibility of fever after vaccination.

    Shock

    Certain events were previously regarded as contraindications to continuation of DTP immunization but are now considered precautions to subsequent DTP doses. If any of the following events occur in temporal relation to DTP or Pentacel, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered: a collapse or shock-like state such as a hypotonic-hyporesponsive episode within 48 hours, fever of >= 40.5 degrees C (105 degrees F) for 48 hours or less after vaccination and not attributable to other causes, seizures with or without fever within 3 days, or persistent and inconsolable crying for >= 3 hours occurring within 48 hours of vaccination. If a decision is made to withhold the pertussis vaccine (i.e., Pentacel), vaccination with the other antigen components of Pentacel may be indicated.

    Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency

    Pentacel is administered by intramuscular (IM) injection and, thus, should be cautiously given to patients with thrombocytopenia, coagulopathy, or other bleeding disorders. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia) or receiving anticoagulant therapy should be monitored closely when given Pentacel because bleeding can occur at the IM injection site. All steps to avoid hematoma formation are recommended.

    Immunosuppression

    Immunosuppressed patients may have a reduced immune response to Pentacel. Practitioners should refer to the most recent CDC guidelines regarding vaccination of immunosuppressed patients. If possible, vaccination should precede chemotherapy or immunosuppression initiation by at least 2 weeks. Patients vaccinated with an inactivated vaccine such as Pentacel within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Since corticosteroids used in greater than physiologic doses also can reduce the immune response to vaccines, providers should wait at least 1 month after discontinuation of high-dose, systemically absorbed corticosteroid therapy administered for more than 2 weeks before administering vaccines.

    Pregnancy

    No adequate and well-controlled studies have been conducted in pregnant women and the ability of the Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine, Hib; Inactivated Poliovirus Vaccine, IPV vaccine to cause fetal harm or to affect reproduction capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial vaccines to pregnant women have 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.

    Breast-feeding

    According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids (e.g., Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine, Hib; Inactivated Poliovirus Vaccine, IPV vaccine, or Pentacel), 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. This particular vaccine is not indicated for use in women of childbearing age; however, the individual vaccine components are approved and are the potential alternatives to consider. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.

    Infection

    Deferral of Pentacel administration may be appropriate for a patient with a moderate or severe acute illness such as infection with or without fever. Pentacel may be administered to a patient with a mild acute illness with or without fever. Among the most common conditions often inappropriately considered contraindications are diarrhea, minor upper respiratory tract illnesses such as otitis media with or without fever, current antimicrobial therapy, and the convalescent phase of an acute illness. The decision to administer or delay vaccination because of a current or recent acute illness depends on symptom severity and disease etiology. Antigenuria has been detected in some instances after receipt of ActHIB, which is a component of the Pentacel vaccine. Urine antigen detection may not have definite diagnostic value in suspected Haemophilus influenzae type b disease within one week of receipt of a Pentacel dose.

    ADVERSE REACTIONS

    Severe

    anaphylactic shock / Rapid / Incidence not known
    cyanosis / Early / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known
    bronchospasm / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known
    seizures / Delayed / Incidence not known
    muscle paralysis / Delayed / Incidence not known
    Guillain-Barre syndrome / Delayed / Incidence not known
    aluminum toxicity / Delayed / Incidence not known
    myelitis / Delayed / Incidence not known
    apnea / Delayed / Incidence not known
    increased intracranial pressure / Early / Incidence not known
    thrombotic thrombocytopenic purpura (TTP) / Delayed / Incidence not known
    hemolytic anemia / Delayed / Incidence not known

    Moderate

    erythema / Early / 7.1-17.3
    dyspnea / Early / Incidence not known
    hypotension / Rapid / Incidence not known
    lymphadenopathy / Delayed / Incidence not known
    hypotonia / Delayed / Incidence not known
    encephalopathy / Delayed / Incidence not known
    neuritis / Delayed / Incidence not known
    peripheral neuropathy / Delayed / Incidence not known

    Mild

    irritability / Delayed / 53.5-76.9
    inconsolable crying / Delayed / 35.9-59.3
    injection site reaction / Rapid / 5.0-56.1
    lethargy / Early / 24.1-45.8
    fever / Early / 5.8-16.3
    chills / Rapid / Incidence not known
    headache / Early / Incidence not known
    drowsiness / Early / Incidence not known
    arthralgia / Delayed / Incidence not known
    maculopapular rash / Early / Incidence not known
    rash / Early / Incidence not known
    pruritus / Rapid / Incidence not known
    urticaria / Rapid / Incidence not known
    weakness / Early / Incidence not known
    hypoesthesia / Delayed / Incidence not known
    paresthesias / Delayed / Incidence not known
    diarrhea / Early / Incidence not known
    anorexia / Delayed / Incidence not known
    vomiting / Early / Incidence not known
    nausea / Early / Incidence not known
    syncope / Early / Incidence not known
    purpura / Delayed / Incidence not known

    DRUG INTERACTIONS

    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 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment.

    PREGNANCY AND LACTATION

    Pregnancy

    No adequate and well-controlled studies have been conducted in pregnant women and the ability of the Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine, Hib; Inactivated Poliovirus Vaccine, IPV vaccine to cause fetal harm or to affect reproduction capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial vaccines to pregnant women have 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.

    According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids (e.g., Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine, Hib; Inactivated Poliovirus Vaccine, IPV vaccine, or Pentacel), 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. This particular vaccine is not indicated for use in women of childbearing age; however, the individual vaccine components are approved and are the potential alternatives to consider. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.

    MECHANISM OF ACTION

    Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine; Inactivated Poliovirus Vaccine, IPV (Pentacel®) helps to confer immunity against bacteria that cause diphtheria, tetanus, pertussis (whooping cough), and haemophilus influenzae type b, as well as the virus that causes polio.
     
    •Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP: The pathologic sequelae of Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, which is an extracellular protein metabolite of toxigenic strains of C. diphtheriae. Diphtheria toxoid induces the production of antibodies against the exotoxin. Antibodies inactivate the toxin presumably by standard antibody-antigen interactions. Infection with C. diphtheriae does not necessarily confer immunity, and previously infected individuals should still receive the 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, and antibodies inactivate the toxin. Natural immunity to C. tetani does not occur in the United States, and 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 contain different pertussis antigens (e.g., agglutinogen, filamentous hemagglutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components. Clinical studies suggest the vaccine 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.
     
    •Inactivated poliovirus vaccine, IPV: Poliovirus vaccine, inactivated, IPV stimulates the immune system to produce antibodies against poliovirus wild-types 1, 2, and 3. After intramuscular or subcutaneous administration, the antigens (inactivated viruses) get presented to the antigen-presenting cells (e.g., B cells, macrophages). The antigen-presenting cells process and present the antigens and allow B-cells to proliferate, differentiate, and produce anti-poliovirus serum antibodies. The serum anti-poliovirus antibodies are capable of opsonization, neutralization, and complement activation. In natural infection, the polio viruses invade and replicate in mucosal tissues. The virus may invade the blood stream and produce disease at distant systemic sites. Parenteral immunization with non-replicating agents such as the IPV may fail to induce specific mucosal responses. Vaccination with either IPV or the live attenuated oral poliovirus vaccine (OPV) usually induces secretory antibody (IgA) production in the pharynx and gut, but mucosal immunity induced by IPV is less than mucosal immunity induced by OPV. The development of serum anti-poliovirus antibodies caused by either OPV or IPV are effective in the prevention of systemic disease despite their different routes of administration. The IPV helps reduce pharyngeal acquisition of poliovirus and to a lesser extent, intestinal acquisition. Herd immunity is possible with IPV, including populations vaccinated only with IPV.
     
    •Haemophilus influenzae type b conjugate vaccine B Vaccine: The high virulence of Haemophilus influenza type b (Hib) is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. The Haemophilus influenzae type b conjugate vaccine contains the capsule polysaccharides from Hib conjugated to a variety of oligosaccharides. Haemophilus influenzae type b conjugate vaccine exposure stimulates the immune system to produce Hib capsule-specific antibodies that presumably destroy the capsule, making the organism vulnerable to antibody and cell-mediated immunity. Unconjugated capsule polysaccharide vaccines cause B-cell stimulation only; conjugation of the capsule polysaccharide also results in T-cell stimulation, which makes antibodies more persistent and more likely to be stimulated with subsequent exposure to Hib antigens.

    PHARMACOKINETICS

    Pentacel is administered intramuscularly.
     
    One month after the fourth dose, most Pentacel recipients had a diphtheria and tetanus antitoxin concentration of at least 0.1 IU/ml, which is a concentration that is generally regarded as protective. Specifically, 92.9% of Pentacel recipients met the threshold concentration for tetanus, and 96.5% met the threshold concentration for diphtheria. In contrast, 99.4% of Daptacel recipients met the threshold concentration for tetanus, and 95.7% met the threshold concentration for diphtheria. Further, similar protection against polio was afforded by either Pentacel or IPOL. One month after the third dose of either Pentacel or IPOL, at least 99.4% of patients had a neutralizing antibody level of at least 1:8 for poliovirus types 1, 2, and 3.
     
    In regard to Haemophilus influenzae protection, anti-PRP antibody has been shown to correlate with protection against invasive disease due to Haemophilus influenzae type b. Similar percentages of patients who got either Pentacel or ActHIB achieved an anti-PRP of at least 1 mcg/ml at least 3 weeks after vaccination, which is a concentration that predicts protection through a subsequent one-year period. In 2 studies, 72.1—75.1% of Pentacel recipients and 70.8—74.8% of ActHIB recipients met the threshold anti-PRP concentration one month after 3 doses of the vaccines given at 2, 4, and 6 months of age.
     
    Both Pentacel and Daptacel contain five acellular pertussis antigens: pertussis toxin (PT) detoxified, filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM). The amount of PRN and FIM per dose in Pentacel and Daptacel is identical, but Pentacel has twice the amount of PT and four times the amount of FHA as compared with Daptacel. In regard to pertussis protection, similar percentages of patients had at least a 4-fold rise in the anti-PT, anti-PRN, anti-FHA, and anti-FIM concentrations one month after the fourth dose of either Pentacel or Daptacel. However, the geometric mean concentration (GMC) for anti-PRN was lower (93.59 EU/ml) after Pentacel as compared with the GMC after Daptacel (186.07 EU/ml).