The Haemophilus influenzae type b conjugate vaccine is an intramuscular vaccine indicated for prevention of infection from Haemophilus influenzae type b (Hib). Hib disease occurs primarily among children under 5 years of age, and the risk of invasive Hib disease is increased in daycare attendees; lower socioeconomic groups; household contacts of cases; or individuals with asplenia, sickle cell disease, or other antibody deficiency syndromes. The primary vaccine series against Haemophilus influenzae type b (Hib) consists of 2 or 3 doses (depending on the product used) given between the ages of 2 and 6 months plus a booster dose ideally given between 12 to 15 months of age. Different formulations of the Hib vaccine are commercially available; each formulation utilizes purified capsular polysaccharide of Hib conjugated via covalent bonding to another antigen to increase immunogenicity. Liquid PedvaxHIB contains Hib capsular polysaccharide (i.e., polyribosylribitol phosphate, PRP) covalently linked to a meningococcal outer membrane protein (OMP) carrier whereas ActHIB and Hiberix are PRP-tetanus toxoids (PRP-TT) conjugate Hib vaccines. Although these antigens are derived from other microorganisms, the Hib vaccine does not confer immunity against these other organisms. The Hib vaccines are used in primary series and booster immunization in infants as young as 6 weeks. ActHIB was FDA approved in September 1996, and Liquid PedvaxHIB was FDA approved in February 1990. Hiberix, a formulation initially indicated only as a booster dose after receipt of a primary series with a vaccine licensed for primary immunization (ActHIB or Liquid PedvaxHIB), was FDA approved in August 2009. In January 2016, the Hiberix indication was expanded to include patients 6 weeks through 18 months.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-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.
Route-Specific Administration
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.
Intramuscular Administration
Reconstitution
ActHIB
-Reconstitute with the provided saline diluent (0.4% NaCl Injection).
-To reconstitute, attach an appropriate sterile needle and withdraw 0.6 mL of saline diluent. Inject the diluent into the vial of lyophilized ActHIB vaccine and thoroughly agitate. Withdraw a 0.5 mL dose of reconstituted vaccine into the syringe.
-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. Discard unused portion.
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 younger 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 younger 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.
Of 1118 children who received the haemophilus influenzae type b conjugate vaccine (HibTITER), 2% had anorexia. Diarrhea occurred in 2.5% and vomiting in 1.4% of children age 15-23 months who got a dose of HibTITER. A greater percentage of patients who received the haemophilus influenzae type b conjugate vaccine (Hiberix) concomitantly with DTaP; HBV; IPV, had anorexia (22.9%), diarrhea (14.6%), and vomiting (4.9%). Nausea may also occur. Local and systemic adverse reactions usually resolve spontaneously in 24-72 hours. Instruct patients or caregivers to report any signs and symptoms of a systemic reaction.
Of 1118 children who received the haemophilus influenzae type b conjugate vaccine (HibTITER), 8% had drowsiness. Drowsiness was noted in 19.9% of 371 patients who received the haemophilus influenzae type b conjugate vaccine concomitantly with DTaP; HBV; IPV. Rash (unspecified) occurred in 0.5% of children 15-23 months of age who got a dose of HibTITER. Postmarketing adverse drug reactions with the haemophilus influenzae type b conjugate vaccine include but are not limited to anaphylactic shock, anaphylactoid reactions, angioedema, urticaria, rash (unspecified), erythema multiforme, lymphadenopathy, lethargy, and somnolence. As with most post-marketing adverse reactions, causality and incidence are uncertain. Instruct patients to report any signs and symptoms of a systemic reaction. Also, have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis.
An injection site reaction often occurs after haemophilus influenzae type b conjugate vaccine administration. Among ActHIB recipients, 19.2-46.3% had tenderness, 8.8-14.3% had erythema, and 9.6-22.5% had induration. After Hiberix receipt, 24.5% had erythema, 20.5% had local pain, and 14.8% had swelling. Local reactions are usually mild and resolve within 24-48 hours of administration.
Guillain-Barre syndrome has been reported post-marketing with Haemophilus influenzae type b conjugate vaccine. As with most post-marketing adverse reactions, causality and incidence are uncertain.
Adverse reactions were reported with haemophilus influenzae type b conjugate vaccine (HibTITER) administration when it was given alone (in 1118 children), with DTaP and IPV (1,390 to 1,406 patients), and with DTaP; hepatitis B; IPV (371 patients). Prolonged or inconsolable crying was reported in 3.8% (for more than 4 hours) who got HibTITER alone, in 36.2% to 58.5% (with 1.4% to 3.4% lasting more than 3 hours) with DTaP and IPV, and in 0.8% with DTaP; hepatitis B; IPV. Irritability was seen with HibTITER alone (13.3%) and was accompanied with fussiness when given with DTaP and IPV (53.8% to 75.8%, with 4.3% to 5.6% lasting for more than 3 hours). HibTITER given with DTaP; hepatitis B; IPV had reports of fussiness (25.9%). Restlessness was reported during administration with DTaP; hepatitis B; IPV (21.8%). Decreased activity and lethargy were reported during administration with DTaP and IPV (24.1% to 51.1%). There were also reports of fever > 38.3 degrees C within the first 24 hours of vaccination (1.4% in children age 15 to 23 months for HibTITER alone; 8.7% to 16.1% for HibTITER with DTaP and IPV; 34.8% for HibTITER with DTaP; hepatitis B; IPV). Postmarketing, seizures with and without fever and hypotonia in relation to hypotonic-hyporesponsive episodes have been reported. Instruct caregivers and patients to report any signs and symptoms of a fever or a systemic reaction. Seizures are more likely to occur in children with a personal or family history of seizures. Such seizures, occurring in otherwise normal children, do not induce permanent brain damage.
Renal failure (unspecified) has been reported after the administration of the haemophilus influenzae type b conjugate vaccine; a cause and effect relationship to the vaccine has not been established.
Postmarketing, syncope has been noted with the haemophilus influenzae type b conjugate vaccine. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Have procedures in place to avoid falling injury and to restore cerebral perfusion after syncope.
Apnea has been reported following administration of the Haemophilus influenzae type b conjugate vaccine to premature infants. For infants born prematurely, consider the medical status, the potential benefits, and the possible risks of vaccination when deciding the timeframe of intramuscular vaccine administration, such as this.
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.
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.
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.
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.
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. 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.
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.
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.
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.
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.
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 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. 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. 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.
General dosing information:
-PedvaxHIB, ActHIB, and Hiberix may be used for primary and booster immunization against Haemophilus influenzae type b.
-All brands of Hib conjugate vaccines are interchangeable for primary and booster doses.
-Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with Haemophilus influenzae type b conjugate vaccine. There is no need to start the primary series over again, regardless of the time between doses.
-Immunization with ActHIB or Hiberix, which are tetanus toxoid conjugate vaccines, is not a substitute for routine tetanus immunization.
-Premature infants should be immunized according to their chronological age, regardless of birth weight.
-For American Indians and Alaska natives, Haemophilus influenzae type b meningitis peaks at a younger age (4 to 6 months) as compared to other US infant populations (6 to 7 months). To ensure early protection in these populations, vaccination with PedvaxHIB is preferred as it produces a protective antibody response after the first vaccine.
-Pediatric patients younger than 24 months who develop invasive disease should be considered unvaccinated (regardless of previous vaccinations). These children should receive the age-appropriate primary vaccination series or be re-vaccinated with a second primary series beginning 4 weeks after onset of the disease.
-Patients receiving the vaccine within 14 days of initiating chemotherapy or while on chemotherapy and/or radiation therapy should be considered unimmunized; repeat doses starting at least 3 months from completion of therapy.
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.
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 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).
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.
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.
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.
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.
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.
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.
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.
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 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).
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.
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.
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 months to 5 years: 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 8 weeks apart.
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).
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.
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.
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 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).
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.
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.
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 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.
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.
Maximum Dosage Limits:
-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.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Albuterol; Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Betamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Bimekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticosteroids (systemic): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticotropin, ACTH: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Cortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deflazacort: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Dexamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hydrocortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methylprednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Prednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Prednisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Triamcinolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Vamorolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
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.
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.
-Special Populations
Pediatrics
Infants and Children 6 weeks to 24 months
The immunogenicity of Haemophilus influenzae type b conjugate vaccine (ActHIB) was evaluated in 2 clinical trials during which infants received doses at 2, 4, and 6 months of age. Post third dose, geometric mean titers of anti-PRP antibodies ranged from 3.64 to 6.37, with 83% to 97% of infants developing a concentration at least 1 mcg/mL (a concentration considered indicative of long-term protection). In a trial of Native American children, after 3 doses of ActHIB at 6 weeks, 4 months, and 6 months of age, 75% developed anti-PRP antibody titers at least 1 mcg/mL. In previously unvaccinated children 12 to 24 months of age who received 1 dose of ActHIB, 90% of those 12 to 15 months and 82% of those 17 to 24 months developed anti-PRP antibody titers at least 1 mcg/mL. In immunogenic children with sickle cell anemia and a mean age of 11 months, 2 doses of ActHIB induced anti-PRP titers at least 1 mcg/mL in 89%. In a randomized clinical study involving 903 infants 2 to 6 months of age who received PedvaxHIB, 80% of infants developed anti-PRP titers at least 1 mcg/mL after a primary 2 dose regimen. After booster immunization at 12 to 15 months, 95% developed titers greater than 1 mcg/mL. The immune response to Hiberix was evaluated in children 16 to 23 months of age who received the booster vaccine following a primary immunization series with Hib. Post-immunization, 97.6% to 100% of children developed anti-PRP titers at least 1 mcg/mL.