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Haemophilus b Conjugate Vaccine

Pronunciation

(he MOF fi lus bee KON joo gate vak SEEN)

Index Terms

  • Haemophilus influenzae Type b
  • Hib
  • PRP-OMP (PedvaxHIB)
  • PRP-T (ActHIB)
  • PRP-T (Hiberix)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, powder for reconstitution [preservative free]:

ActHIB Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus toxoid 24 mcg] per 0.5 mL [contains sucrose; may be reconstituted with provided diluent (forms solution; contains natural rubber/natural latex in packaging)]

Hiberix: Haemophilus b capsular polysaccharide 10 mcg [bound to tetanus toxoid 25 mcg] per 0.5 mL (0.5 mL) [contains lactose 12.6 mg]

Injection, suspension:

PedvaxHIB: Haemophilus b capsular polysaccharide 7.5 mcg [bound to Neisseria meningitidis OMPC 125 mcg] per 0.5 mL (0.5 mL) [contains aluminum; natural rubber/natural latex in packaging]

Brand Names: U.S.

  • ActHIB
  • Hiberix
  • PedvaxHIB

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

Stimulates production of anticapsular antibodies and provides active immunity to Haemophilus influenzae type b. Vaccination provides protective antibodies in >95% of infants who are vaccinated with a 2- or 3-dose series (CDC 2012). An anti-PRP concentration of ≥1.0 mcg/mL predicts long-term protection.

Onset of Action

Immunity develops progressively with each dose. Immunity can be inferred ~ 2 weeks after the initial series is complete.

Efficacy: The initial unconjugated polysaccharide Hib vaccines produced 45% to 88% reduction in disease incidence among children at least 18 to 24 months of age. The initial protein-conjugated Hib vaccines produced >90% protection in infants after a multidose series. After the initial Hib conjugate vaccines were licensed, subsequent formulations were licensed based on noninferior antibody responses.

Duration of Action

Antibody concentrations exceeding 0.15 mcg/mL correlate with clinical protection from disease. Antibody concentrations exceeding 1 mcg/mL correlate with prolonged protection from disease, generally implying several years of protection.

Use: Labeled Indications

Active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b (Hib):

ActHIB: Immunization of infants and children 2 months to 5 years of age.

Hiberix: Immunization of infants and children 6 weeks to 4 years of age (prior to fifth birthday).

PedvaxHIB: Routine vaccination of infants and children 2 to 71 months of age.

The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for the following (CDC/ACIP [Kim 2015]; CDC/ACIP [Strikas 2015]); CDC/ACIP [Briere 2014]):

- Routine immunization of all infants and children through age 59 months

- Unimmunized (defined as those who have not received a primary series and booster dose or at least 1 dose of a Hib vaccine after 14 months of age) children 12 to 59 months including chemotherapy recipients, anatomic or functional asplenia (including sickle cell disease), HIV infection, immunoglobulin deficiency or early component complement deficiency

Efficacy data are not available for use in older children and adults with chronic conditions associated with an increased risk of Hib disease. However, use may be considered for:

- Unimmunized (defined as those who have not received a primary series and booster dose or at least 1 dose of a Hib vaccine after 14 months of age) children ≥5 years, adolescents and adults with functional or anatomic asplenia, (including sickle cell disease)

- Unimmunized (defined as those who have not received a primary series and booster dose or at least 1 dose of a Hib vaccine after 14 months of age) children ≥5 years and adolescents with HIV infection

- Children <5 years undergoing chemotherapy or radiation treatment

- Successful hematopoietic stem cell transplant recipients

- Children ≥15 months and adolescents undergoing elective splenectomy

Contraindications

Hypersensitivity to Haemophilus b polysaccharide, tetanus toxoid-containing vaccine (Hiberix and ActHIB only), or any component of the formulation

Dosing: Adult

Immunization: IM:

Adults who have not received the childhood Hib series and are at increased risk for invasive Hib disease due to to sickle cell disease, anatomic/functional asplenia or splenectomy. ACIP recommendations: One dose (0.5 mL); may use any of the Hib conjugate vaccines (CDC/ACIP [Briere 2014])

Adults who are recipients of a successful hematopoietic stem cell transplant: Revaccinate with a 3-dose regimen beginning 6-12 months after the transplant, regardless of vaccination history. Doses should be administered ≥4 weeks apart (CDC/ACIP [Briere 2014]).

Dosing: Pediatric

Primary immunization (CDC/ACIP [Briere 2014]): Note: The number of doses for completion of Hib series is dependent upon products including some combination formulations (3 doses: ActHIB, Hiberix; 2 doses: PedvaxHIB) (see combination product monographs for specific dosing information)

Infants 6 weeks to 6 months: Minimum age for first dose is 6 weeks.

ActHib, Hiberix (PRP-T): IM: 0.5 mL per dose for a total of 3 doses administered as follows: 2, 4, and 6 months of age

PedvaxHIB (PRP-OMP): IM: 0.5 mL per dose for a total of 2 doses administered as follows: 2 and 4 months of age

Booster immunization:

Manufacturer’s labeling:

ActHIB, Hiberix: Children 15 to 18 months: IM: 0.5 mL as a single dose

PedvaxHIB: Children 12 to 15 months: IM: 0.5 mL as a single dose

ACIP recommendation: Children 12 to 15 months: IM: 0.5 mL as a single dose (CDC/ACIP [Briere 2014 ])

Primary immunization of older patients at risk: Children ≥5 years and Adolescents who have not received the childhood Hib series and are at increased risk for invasive Hib disease due to HIV infection, anatomic/functional asplenia or splenectomy, immunoglobulin deficiency, early component complement deficiency, or chemotherapy or radiation therapy. ACIP recommendations: One dose (0.5 mL); may use any of the Hib conjugate vaccines (CDC/ACIP [Briere 2014])

Repeat immunization for high-risk conditions (CDC/ACIP [Briere 2014):

Invasive Hib disease: Infants and Children <24 months: Revaccinate with a second primary series beginning 4 weeks after onset of disease

Undergoing chemotherapy or radiation therapy: Infants and Children <60 months: If dose administered within 14 days of starting or given during therapy: Repeat the vaccine doses at least 3 months after therapy completion

Hematopoietic stem cell transplant recipient: Children and Adolescents: Revaccinate with a 3-dose regimen beginning 6 to 12 months after successful transplant, regardless of vaccination history. Doses should be administered ≥4 weeks apart.

Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Reconstitution

ActHIB: Dilute with 0.6 mL of provided saline diluent (sodium chloride 0.4%); agitate to form a clear, colorless solution. Withdraw 0.5 mL of reconstituted vaccine for administration. Shake well prior to use

Hiberix: Dilute with provided saline diluent only. Transfer entire contents of prefilled syringe containing diluent into the vial; with needle still inserted, shake vigorously until it becomes a clear, colorless solution. Withdraw entire contents of vial (~0.5 mL) for administration. Shake well prior to use.

PedvaxHIB: Used as supplied; no reconstitution is necessary. Shake well; thorough agitation is necessary to maintain suspension of the vaccine.

Administration

For IM administration; do not inject IV, intradermally, or subcutaneously. Shake well prior to use. Administer into the anterolateral thigh or deltoid. Do not administer into buttocks due to potential risk of injury to sciatic nerve. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

ActHIB, PedvaxHIB: If the primary series is delayed or interrupted, there is no need to start the series over, regardless of the interval between doses.

Hiberix: If Hiberix is inadvertently administered during the primary vaccination series, the dose can be counted as a valid PRP-T dose that does not need to be repeated if administered according to schedule. In this case, a total of 3 doses completes the primary series (CDC 58[36] 2009).

For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (NCIRD/ACIP 2011).

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

ActHIB: Store lyophilized powder and diluent under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. If not used immediately after reconstitution, may store under refrigeration for up to 24 hours.

Hiberix: Prior to reconstitution, store powder under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light. Diluent may be stored under refrigeration or at room temperature; do not freeze, discard diluent if frozen. If not used immediately after reconstitution, may store under refrigeration for up to 24 hours.

PedvaxHIB: Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze.

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Test Interactions

May interfere with interpretation of urine antigen detection tests; antigenuria may occur up to 2 weeks following immunization

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

Frequency not defined:

Central nervous system: Crying (unusual, high pitched, prolonged), drowsiness, fussiness, irritability, lethargy, pain, restlessness, seizure

Dermatologic: Skin rash, urticaria

Gastrointestinal: Anorexia, diarrhea, vomiting

Hematologic & oncologic: Thrombocytopenia

Local: Injection site: Erythema, induration, pain, soreness, swelling

Neuromuscular & skeletal: Weakness

Otic: Otitis media

Respiratory: Tracheitis, upper respiratory tract infection

Miscellaneous: Fever

Postmarketing and/or case reports (Limited to important or life-threatening): Abscess at injection site (sterile), anaphylaxis, anaphylactoid reaction, angioedema, apnea, febrile seizures, Guillain-Barré syndrome, hypersensitivity reaction, hypotonic/hyporesponsive episode, lymphadenopathy, mass, peripheral edema, pneumonia, swelling of the injected limb (extensive), syncope, vasodepressor syncope

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP 2011).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP 2011).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (NCIRD/ACIP 2011).

• Guillain-Barré syndrome (GBS): ActHIB, Hiberix: Use with caution in patients with history of GBS; carefully consider risks and benefits to vaccination in patients known to have experienced GBS within 6 weeks following previous tetanus-containing vaccination.

• Tetanus immunization: Immunization with ActHIB or Hiberix does not substitute for routine tetanus immunization.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of Hib containing combination vaccines in a series come from the same manufacturer when possible; monovalent Hib vaccines are interchangeable (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination (NCIRD/ACIP 2011). In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011). inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Pediatric: Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (NCIRD/ACIP 2011).

Dosage form specific issues:

• Lactose: Some products may contain lactose.

• Latex: Packaging may contain natural latex rubber.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Adult Immunization Schedule (CDC/ACIP [Kim 2015]). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions are available from the IDSA (Rubin 2014).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011). Infection may occur within the week of vaccination, prior to the onset of the vaccine.

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Inactivated vaccines have not been shown to cause increased risks to the fetus (NCIRD/ACIP 2011).

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain or irritation, irritability, fatigue, lack of appetite, akathisia, or diarrhea. Have patient report immediately to prescriber paresthesia, facial paralysis, difficulty with motor activity, severe dizziness, syncope, asthenia, or vision changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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