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    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.

    Adult† recipients of a hematopoietic stem cell transplant

    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.[53026] [56777]

    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.[53026] [56777]

    Children 5 years and older† and Adolescents† with sickle cell disease, asplenia, or HIV infection

    0.5 mL IM once if previously unvaccinated or partially vaccinated.

    Children 15 months and older† and Adolescents† undergoing elective splenectomy

    0.5 mL IM once if previously unvaccinated or partially vaccinated (preferably at least 14 days before procedure).[53026]

    Children 12 to 59 months† with sickle cell disease, asplenia, immunoglobulin deficiency, early component complement deficiency, HIV infection, or requiring chemotherapy and/or radiation therapy (unvaccinated or only 1 dose before 12 months)

    0.5 mL IM for 2 doses 8 weeks apart. Repeat doses given within 14 days of starting or during chemotherapy/radiation at least 3 months after chemotherapy/radiation completion.[53026]

    Children 12 to 59 months† with sickle cell disease, asplenia, immunoglobulin deficiency, early component complement deficiency, HIV infection, or requiring chemotherapy and/or radiation therapy (received 2 or more doses before 12 months)

    0.5 mL IM at least 8 weeks after previous dose. Repeat doses given within 14 days of starting or during chemotherapy/radiation at least 3 months after chemotherapy/radiation completion.[53026]

    Infant†, Children†, and Adolescent† recipients of a hematopoietic stem cell transplant

    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.

    Children 15 to 18 months of age at first dose

    0.5 mL IM once.

    Children 12 to 14 months of age at first dose


    0.5 mL IM for 2 doses administered 8 weeks apart.[31601] [53026]

    Infants 7 to 11 months of age at first dose


    0.5 mL IM for a total of 3 doses. ACIP recommends giving the second dose at least 4 weeks after the first dose and then administering the final dose (booster dose) at 12 to 15 months of age or 8 weeks after the second dose, whichever is later. The FDA-approved product label recommends an 8-week interval between the first and second dose and then administration of the booster dose between 15 to 18 months.[31601] [53026] [56777]

    Infants 2 to 6 months of age at first dose

    0.5 mL IM for a total of 4 doses. Give the first 3 doses at intervals of at least 4 weeks, ideally at 2, 4, and 6 months of age; however, the first dose can be given to infants as young as 6 weeks. ACIP recommends administering the 4th dose (booster dose) at 12 to 15 months of age; the FDA-approved product label recommends administration between 15 to 18 months.[31601] [53026] [56777]

    Infants 6 weeks to younger than 2 months†

    0.5 mL IM. Although not FDA-approved for infants younger than 2 months of age, the minimum age for the first dose of the 3-dose primary series recommended by the ACIP is 6 weeks.[53026]

    Intramuscular dosage (Liquid PedvaxHIB)

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

    Adult† recipients of a hematopoietic stem cell transplant

    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.[53026] [56777]

    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.[53026] [56777]

    Children 5 years and older† and Adolescents† with sickle cell disease, asplenia, or HIV infection

    0.5 mL IM once if previously unvaccinated or partially vaccinated.

    Children 15 months and older† and Adolescents† undergoing elective splenectomy

    0.5 mL IM once if previously unvaccinated or partially vaccinated (preferably at least 14 days before procedure).[53026]

    Children 12 to 59 months† with sickle cell disease, asplenia, immunoglobulin deficiency, early component complement deficiency, HIV infection, or requiring chemotherapy and/or radiation therapy (unvaccinated or only 1 dose before 12 months)

    0.5 mL IM for 2 doses 8 weeks apart. Repeat doses given within 14 days of starting or during chemotherapy/radiation at least 3 months after chemotherapy/radiation completion.[53026]

    Children 12 to 59 months† with sickle cell disease, asplenia, immunoglobulin deficiency, early component complement deficiency, HIV infection, or requiring chemotherapy and/or radiation therapy (received 2 or more doses before 12 months)


    0.5 mL IM at least 8 weeks after previous dose. Repeat doses that are given within 14 days of starting or during chemotherapy/radiation at least 3 months after chemotherapy/radiation completion.[53026]

    Infant†, Children†, and Adolescent† recipients of a hematopoietic stem cell transplant


    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.[53026] [56777]

    Children 15 months to 5 years


    0.5 mL IM once (if previously unvaccinated).[53026]

    Children 12 to 14 months of age at first dose


    0.5 mL IM for 2 doses 8 weeks apart. [42864] [53026] [56777]

    Infants 2 to 11 months of age at first dose

    0.5 mL 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).[42864] [53026]

    Infants 6 weeks to younger than 2 months†

    0.5 mL IM. Although not FDA-approved for infants younger than 2 months of age, the minimum age for the first dose of the 2-dose primary series recommended by the ACIP is 6 weeks.[53026]

    Intramuscular dosage (Hiberix)
    Adult† recipients of a hematopoietic stem cell transplant

    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.[53026] [56777]

    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.[53026] [56777]

    Children 5 years and older† and Adolescents† with sickle cell disease, asplenia, or HIV infection

    0.5 mL IM once if previously unvaccinated or partially vaccinated.

    Children 15 months and older† and Adolescents† undergoing elective splenectomy

    0.5 mL IM once if previously unvaccinated or partially vaccinated (preferably at least 14 days before procedure).[53026]

    Children 12 to 59 months† with sickle cell disease, asplenia, immunoglobulin deficiency, early component complement deficiency, HIV infection, or requiring chemotherapy and/or radiation therapy (unvaccinated or only 1 dose before 12 months)

    0.5 mL IM for 2 doses 8 weeks apart. Repeat doses given within 14 days of starting or during chemotherapy/radiation at least 3 months after chemotherapy/radiation completion.[53026]

    Children 12 to 59 months† with sickle cell disease, asplenia, immunoglobulin deficiency, early component complement deficiency, HIV infection, or requiring chemotherapy and/or radiation therapy (received 2 or more doses before 12 months)


    0.5 mL IM at least 8 weeks after previous dose. Repeat doses given within 14 days of starting or during chemotherapy/radiation at least 3 months after chemotherapy/radiation completion.[53026]

    Infant†, Children†, and Adolescent† recipients of a hematopoietic stem cell transplant


    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.[53026] [56777]

    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 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 2 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.[39162] [53026] [56777]

    Infants 6 weeks to 6 months of age at first dose

    0.5 mL IM 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 the FDA-approved product label.[39162] [53026] [56777]

    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

     
    Record the manufacturer and lot number of the vaccine; date of administration; and the name, address, and title of the person who administered the vaccine in the recipient's permanent medical record. These actions are required by the National Childhood Vaccine Injury Act of 1986.
    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.
    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 reactions have been identified. The reporting of reactions 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 reaction to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated.

    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% NaCl Injection 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 Injection) or with Tripedia vaccine (which contains diphtheria, tetanus, and acellular pertussis 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 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.
    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
    Attach an appropriate sterile needle (if not used during reconstitution).
    For the majority of infants less than 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.
    For children 1 to 2 years, a needle at least 1 inch long is preferred for administration into the thigh; a 5/8 inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90 degree angle.
    For children 3 years and older, the needle size required for deltoid injection ranges from 5/8- to 1-inch.
    Inject into the anterolateral aspect of the thigh (preferred for infants and children less than 2 years of age) or the deltoid muscle of the upper arm (usually suitable for older pediatric patients and adults). Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
    When concomitant administration of other vaccines or immunoglobulin is required, administer with different syringes and at different injection sites.

    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

    Haemophilus influenzae type b conjugate vaccine is not approved for use in adults. Human and animal reproduction studies to assess vaccine associated risks in pregnancy have not been conducted, and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown.[31601] [39162] [42864]

    Breast-feeding

    Haemophilus influenzae type b conjugate vaccine is not approved for use in patients older than 6 years. Human and animal data are not available to assess the impact of Haemophilus influenzae type b conjugate vaccine on milk production, its presence in breast milk, or its effects on the breast-fed infant.[31601] 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.[43236]

    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.

    Laboratory test interference

    Laboratory test interference may occur after receipt of the Haemophilus influenzae type b conjugate vaccine. Specifically, Haemophilus b capsular polysaccharide derived from Haemophilus influenzae type b conjugate vaccine has been detected in urine samples after vaccination.[31601] Sensitive tests (e.g., Latex Agglutination Kits) may detect PRP derived from the Haemophilus influenzae type b conjugate vaccine in some patients' urine for at least 30 days after vaccination. In clinical studies of lyophilized PedvaxHIB, these patients had a normal immune response to the vaccine.[42864] Urine antigen detection may not have diagnostic value in suspected disease due to Haemophilus influenzae type B within 1 to 2 weeks after receipt of a Haemophilus influenzae type b-containing vaccine.[31601]

    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 / 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

    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.
    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

    Haemophilus influenzae type b conjugate vaccine is not approved for use in adults. Human and animal reproduction studies to assess vaccine associated risks in pregnancy have not been conducted, and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown.[31601] [39162] [42864]

    Haemophilus influenzae type b conjugate vaccine is not approved for use in patients older than 6 years. Human and animal data are not available to assess the impact of Haemophilus influenzae type b conjugate vaccine on milk production, its presence in breast milk, or its effects on the breast-fed infant.[31601] 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.[43236]

    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.