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  • CLASSES

    HIB Vaccines

    DEA CLASS

    Rx

    DESCRIPTION

    Intramuscular vaccine in the primary childhood immunization series
    Used for protection against Haemophilus influenzae type b
    Primary vaccine series against Hib consists of 2 or 3 doses (depending on product used) given between 2 and 6 months of age plus a booster dose ideally given between 12 to 15 months of age

    COMMON BRAND NAMES

    ActHIB, Hiberix, PedvaxHIB

    HOW SUPPLIED

    ActHIB/Hiberix Intramuscular Inj Pwd F/Sol: 0.5mL, 10mcg
    PedvaxHIB Intramuscular Inj Sol: 0.5mL, 7.5mcg

    DOSAGE & INDICATIONS

    For Haemophilus influenzae type b prophylaxis.
    Intramuscular dosage (ActHIB)

    NOTE: For dosing information for TriHIBit (ActHIB reconstituted with Tripedia) see the Diphtheria/Tetanus Toxoids; Pertussis Vaccine; Haemophilus influenzae type b Conjugate Vaccine monograph.

    Recipients of a hematopoietic stem cell transplant, all ages†

    0.5 mL IM for 3 doses given at least 4 weeks apart; begin the series 6 to 12 months after a successful transplant regardless of prior vaccination history.

    Adults with sickle cell disease, asplenia, or undergoing elective splenectomy (administered at least 14 days prior to splenectomy)†

    0.5 mL IM once (if previously unvaccinated).

    Children 5 years and older† and Adolescents† with sickle cell disease, leukemia, malignant neoplasms, asplenia, HIV infection, or other immunocompromising conditions

    0.5 mL IM once (if previously unvaccinated or partially vaccinated).

    Infants 2 to 6 months of age at first dose

    0.5 mL IM per dose for 4 total doses. Give the first 3 doses at intervals of at least 4 weeks, ideally at 2, 4, and 6 months of age; the first dose can be given to infants as young as 6 weeks. Give the 4th dose (booster dose) at 12 to 15 months of age per ACIP recommendations or at 15 to 18 months per the FDA-approved product label.

    Infants 6 weeks to less than 2 months†

    Although not FDA-approved for infants less than 2 months of age, the minimum age recommended by Advisory Committee on Immunization Practices (ACIP) for vaccination is 6 weeks.

    Intramuscular dosage (Liquid PedvaxHIB)

    NOTE: PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the primary and booster doses.

    Hematopoietic stem cell transplant recipients (all ages)†

    0.5 mL IM for 3 doses is recommended by the Advisory Committee on Immunization Practices (ACIP). Vaccination should be given regardless of vaccination history, initiated 6 to 12 months after a successful transplant, and each dose should be separated by at least 4 weeks.

    Adults with sickle cell disease, asplenia, or undergoing elective splenectomy†

    0.5 mL IM once (if previously unvaccinated). For those undergoing elective splenectomy, administer at least 14 days prior to splenectomy.

    Children 6 years and older and Adolescents with HIV, sickle cell disease, asplenia, or undergoing elective splenectomy†

    0.5 mL/dose IM once (if previously unvaccinated or partially vaccinated). For those undergoing elective splenectomy, administer at least 14 days prior to splenectomy.

    Children 15 months to 5 years

    0.5 mL IM once (if previously unvaccinated).

    Infants and Children 12 to 14 months of age at first dose

    0.5 mL/dose IM for 2 doses 8 weeks apart.

    Infants 2 to 11 months of age at first dose

    0.5 mL/dose IM for a total of 3 doses. Give the first 2 doses 8 weeks apart, ideally at 2 and 4 months of age. The third dose (booster) is recommended to be given at 12 to 15 months of age (at least 8 weeks after the second dose).

    Infants 6 weeks to younger than 2 months†

    Although not FDA-approved for infants less than 2 months of age, the minimum age recommended by Advisory Committee on Immunization Practices (ACIP) for vaccination is 6 weeks.

    Intramuscular dosage (Hiberix)
    Children 15 to 59 months (previously unvaccinated)

    0.5 mL IM once (if previously unvaccinated).

    Children 12 to 14 months of age at first dose

    0.5 mL IM for 2 doses administered 8 weeks apart.

    Infants 7 to 11 months of age at first dose

    0.5 mL IM per dose for 3 total doses. ACIP recommends a 4 week interval between the first and second doses, and then giving the final (booster) dose at the later of the following two dates: 8 weeks after the second dose or 12 to 15 months of age. The FDA-approved product label recommends giving the final (booster) dose at age 15 to 18 months.

    Infants 6 weeks to 6 months of age at first dose

    0.5 mL IM per dose for 4 total doses. Give the first 3 doses at intervals of at least 4 weeks, ideally at 2, 4, and 6 months of age; the first dose can be given to infants as young as 6 weeks. Give the 4th dose (booster dose) at age 12 to 15 months per ACIP recommendations or at 15 to 18 months per FDA-approved product label.

    MAXIMUM DOSAGE

    Adults

    0.5 mL/dose IM.

    Geriatric

    0.5 mL/dose IM.

    Adolescents

    0.5 mL/dose IM.

    Children

    0.5 mL/dose IM.

    Infants

    < 6 weeks: Use not recommended.
    >= 6 weeks: 0.5 mL IM. While neither ActHIB nor Liquid PedvaxHIB are FDA-approved for infants < 8 weeks, ACIP states that the first vaccination can occur in infants as young as 6 weeks.

    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

     
    NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine.
    The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.
    If a Haemophilus influenzae type b vaccine 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 (see Contraindications).

    Injectable Administration

    Administer intramuscularly (IM) only; do not inject intravenously or intradermally.
    Visually inspect parenteral products for particulate matter and discoloration prior to administration. ActHIB reconstituted with 0.4% sodium chloride is a clear, colorless solution; Reconstituted Hiberix is a clear, colorless solution; Liquid PedvaxHIB is a slightly opaque, white suspension; and ActHIB is whitish in color if reconstituted with either AvP DTP or Tripedia.

    Intramuscular Administration

    Reconstitution:
    ActHIB
    Reconstitute with the provided saline diluent (0.4% NaCl) or with Tripedia vaccine (which contains diphtheria, tetanus, acellular pertussis, and Haemophilus influenzae type b conjugate antigens.
    When using saline diluent for reconstitution:
    The vaccine should be clear and colorless.
    For administration, attach an appropriate sterile needle and withdraw 0.6 mL of saline diluent. Inject the diluent and thoroughly agitate. Withdraw 0.5 mL of reconstituted vaccine into the syringe.
    Storage of reconstituted vaccine: Administer promptly after reconstitution or store refrigerated between 2 and 8 degrees C (35—46 degrees F) and administer within 24 hours of reconstitution; do not freeze. If not administered immediately after reconstitution, agitate the vial again before withdrawing the dose.
    When using Tripedia vaccine for reconstitution:
    Thoroughly agitate Tripedia vial, then withdraw 0.6 mL and inject into the ActHIB vial. After thorough agitation, the combined vaccines should be a whitish color.
    Withdraw 0.5 mL of the combined vaccines.
    Storage of reconstituted vaccine: Administer within 30 minutes of reconstitution.
     
    Hiberix
    Reconstitute only with the provided saline diluent. Attach an appropriate sterile needle and transfer the entire contents of the prefilled syringe into the vial. With the needle still inserted, shake the vial vigorously, and then withdraw the entire contents of the vial (approximately 0.5 mL).
    The vaccine should be clear and colorless.
    Storage of reconstituted vaccine: Administer promptly after reconstitution or store refrigerated between 2 and 8 degrees C (35 to 46 degrees F) and administer within 24 hours of reconstitution; do not freeze. If not administered immediately after reconstitution, agitate the vial again before withdrawing the dose.
     
    PedvaxHIB
    PedvaxHIB is supplied as a suspension and does not require reconstitution.
    The vaccine is a slightly opaque, white suspension.
    Shake vial well before withdrawing the dose.
     
    Intramuscular (IM) injection:
    Shake the Liquid PedvaxHIB suspension well before withdrawal from the vial. If reconstituted Hiberix was not used immediately (stored under refrigeration for up to 24 hours), vigorously shake the vaccine before withdrawing the dose for injection; withdraw the entire contents of the vial. The solution should be clear and colorless.
    Prior to administration, clean skin over the injection site with a suitable cleansing agent.
    Inject deeply into the anterolateral or midlateral muscles of the thigh or outer aspect of the upper arm. Aspirate prior to injection to avoid injection into a blood vessel. Take care to avoid injury to major peripheral nerve trunks. Do not inject into the gluteal area.

    STORAGE

    ActHIB:
    - Do not freeze
    - Store between 35 to 46 degrees F
    Hiberix:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Do not freeze reconstituted product
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    - Store diluent separately at room temperature (68 to 77 degrees F) or in the refrigerator (36 to 46 degrees F)
    - Store reconstituted product in refrigerator (36 to 46 degrees F)
    - Store unreconstituted product in refrigerator (36 to 46 degrees F)
    - Use within 24 hours from time of preparation
    HibTITER:
    - Avoid use of product if it has been frozen
    - Protect from freezing
    - Refrigerate (between 36 and 46 degrees F)
    PedvaxHIB:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Protect from freezing
    - Refrigerate (between 36 and 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Intravenous administration

    Do not give Haemophilus influenzae type b conjugate vaccine via intravenous 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.

    Latex hypersensitivity

    The Haemophilus influenzae type b conjugate vaccine should be used cautiously in patients with a history of Haemophilus influenza vaccine hypersensitivity, tetanus toxoid hypersensitivity, or Neisseria meningitidis vaccine hypersensitivity because antigens related to these products are used in some of the Haemophilus influenzae type b conjugate vaccines. Patients with latex hypersensitivity may not be appropriate candidates for the Liquid PedvaxHIB vaccine or the Hiberix vaccine. The vial stopper of Liquid PedvaxHIB contains dry natural latex rubber and the tip caps of the prefilled syringes of diluent for Hiberix may contain natural rubber latex; the rubber plungers of the prefilled syringes and the vial stoppers of Hiberix do not contain latex. 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 (1mg/mL) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the vaccine. Prior to the administration of the vaccine, the health care personnel should inform the parent, guardian, or responsible adult of the benefits and risks to the patient. 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. Immunization with Liquid PedvaxHIB is contraindicated in any patient with a history of hypersensitivity to any of the vaccine components or diluent. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of Liquid PedvaxHIB. Hiberix and ActHIB are contraindicated for use by patients with a severe allergic reaction such as anaphylaxis after a previous dose of any Haemophilus influenzae type b or tetanus toxoid-containing vaccine or to any component of the vaccine. The U.S. 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.

    Infants, neonates, premature neonates

    Neonates and infants younger than 6 weeks of age should not get Haemophilus influenzae type b conjugate vaccine because a dose given at this time may lead to immune tolerance and reduce the infant’s response to subsequent doses. Apnea has been observed in some premature neonates administered the Haemophilus influenzae type b conjugate vaccine. For infants born prematurely, consider their medical status, the potential benefits, and the possible risks of vaccination timeframe when giving an intramuscular vaccine such as this.

    Pregnancy

    The Haemophilus influenzae type b conjugate vaccine is an FDA pregnancy risk category C agent. Animal reproduction studies have not been conducted, and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown.

    Breast-feeding

    According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as Haemophilus influenzae type b conjugate vaccine, pose no risk for nursing mothers or their infants. Similarly, breast-feeding does not adversely affect immunization of the mother or infant; limited data suggest breast-feeding can enhance the immune response to certain vaccine antigens. 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.

    Agammaglobulinemia, corticosteroid therapy, human immunodeficiency virus (HIV) infection, hypogammaglobulinemia, immunosuppression, leukemia, lymphoma, neoplastic disease, severe combined immunodeficiency (SCID)

    Patients suffering significant immunosuppression may not have an adequate antibody response to vaccination. Immunosuppressed persons may include patients with asymptomatic or symptomatic human immunodeficiency virus (HIV) infection; severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized neoplastic disease; or an immune system compromised by corticosteroid therapy with greater than physiologic doses, alkylating drugs, antimetabolites, or radiation. Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with Haemophilus influenzae type b conjugate vaccine 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.

    Guillain-Barre syndrome

    Careful consideration of the potential risks and benefits of immunization with Hiberix or ActHIB (Haemophilus influenzae type b conjugate vaccine that contains inactivated tetanus toxoid) is needed if a patient had Guillain-Barre syndrome within 6 weeks of receipt of a prior vaccine that contained tetanus toxoid.

    Fever, infection

    The decision to administer or to delay vaccination with the Haemophilus influenzae type b conjugate vaccine because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices has recommended that vaccination should be delayed during the course of an acute febrile illness. 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. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness. Minor illnesses such as upper respiratory infection with or without low-grade fever are not contraindications for use of the ActHIB vaccine.

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

    The Haemophilus influenzae type b conjugate vaccine is given intramuscularly and, thus, should be given cautiously to persons receiving anticoagulant therapy. Also, patients with thrombocytopenia, coagulopathy (e.g., hemophilia), other bleeding disorders, or vitamin K deficiency should be monitored closely when given the vaccine because bleeding can occur at the IM injection site. All steps to avoid hematoma formation are recommended.

    Native American patients

    Liquid PedvaxHIB contains Hib capsular polysaccharide (i.e., polyribosylribitol phosphate, PRP) covalently linked to a meningococcal outer membrane protein (OMP) carrier whereas ActHIB is a PRP-tetanus toxoid (PRP-TT) conjugate Hib vaccine. Administration of a PRP-OMP vaccine such as PedvaxHIB for the primary series is recommended for vaccination of Native American patients/Alaska Native patients in Native American/Alaska Native communities. As compared with a PRP-TT vaccine such as ActHIB, the administration a PRP-OMP vaccine leads to a more rapid seroconversion to protective antibody concentrations within the first 6 months of life. Failure to use a PRP-OMP vaccine for the first dose is associated with excess cases of Hib disease in Native American/Alaska Native infants living in communities where Hib transmission is ongoing and exposure to colonized persons is likely. The PRP-TT and PRP-OMP vaccines are equally effective after completion of the primary series.

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / Incidence not known
    erythema multiforme / Delayed / Incidence not known
    angioedema / Rapid / Incidence not known
    anaphylactic shock / Rapid / Incidence not known
    Guillain-Barre syndrome / Delayed / Incidence not known
    seizures / Delayed / Incidence not known
    renal failure (unspecified) / Delayed / Incidence not known
    apnea / Delayed / Incidence not known

    Moderate

    erythema / Early / 8.8-24.5
    lymphadenopathy / Delayed / Incidence not known
    hypotonia / Delayed / Incidence not known

    Mild

    irritability / Delayed / 13.3-75.8
    inconsolable crying / Delayed / 0.8-58.5
    lethargy / Early / 24.1-51.1
    injection site reaction / Rapid / 9.6-46.3
    fever / Early / 1.4-16.1
    drowsiness / Early / 8.0-8.0
    diarrhea / Early / 2.5-2.5
    anorexia / Delayed / 2.0-2.0
    vomiting / Early / 1.4-1.4
    rash (unspecified) / Early / 0.5-0.5
    nausea / Early / Incidence not known
    urticaria / Rapid / Incidence not known
    restlessness / Early / Incidence not known
    syncope / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Haemophilus influenzae type b Conjugate Vaccine products.

    PREGNANCY AND LACTATION

    Pregnancy

    The Haemophilus influenzae type b conjugate vaccine is an FDA pregnancy risk category C agent. Animal reproduction studies have not been conducted, and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown.

    According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as Haemophilus influenzae type b conjugate vaccine, pose no risk for nursing mothers or their infants. Similarly, breast-feeding does not adversely affect immunization of the mother or infant; limited data suggest breast-feeding can enhance the immune response to certain vaccine antigens. 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.

    MECHANISM OF ACTION

    The high virulence of Haemophilus influenzae 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 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 results in T-cell stimulation as well, which makes antibodies more persistent and more likely to be stimulated with subsequent exposure to Hib antigens.

    PHARMACOKINETICS

    The Haemophilus influenzae type b conjugate vaccine is administered intramuscularly. Haemophilus influenzae type b conjugate vaccine-induced antibodies (anticapsular antibodies) are detectable approximately 1 to 2 weeks after inoculation. The duration of immunity is unknown. The distribution of anticapsular antibodies has not been fully defined. Anticapsular antibodies distribute into breast milk and may cross the placenta. The exact fate of anticapsular antibodies has not been described.