ActHIB

HIB Vaccines

 
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.

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.

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.

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

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

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

ActHIB, Hiberix, PedvaxHIB

Rx

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

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

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]

0.5 mL IM once if previously unvaccinated. For those undergoing elective splenectomy, administer at least 14 days prior to splenectomy.[53026] [56777]

0.5 mL IM once if previously unvaccinated or partially vaccinated.

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

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]

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]

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.

0.5 mL IM once.

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

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]

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]

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]

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

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]

0.5 mL IM once if previously unvaccinated. For those undergoing elective splenectomy, administer at least 14 days prior to splenectomy.[53026] [56777]

0.5 mL IM once if previously unvaccinated or partially vaccinated.

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

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]

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]

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]

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

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

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]

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]

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]

0.5 mL IM once if previously unvaccinated. For those undergoing elective splenectomy, administer at least 14 days prior to splenectomy.[53026] [56777]

0.5 mL IM once if previously unvaccinated or partially vaccinated.

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

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]

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]

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]

0.5 mL IM once (if previously unvaccinated).

0.5 mL IM for 2 doses administered 8 weeks apart.

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]

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]

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

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

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.
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.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 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.
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.

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

0.5 mL/dose IM.

0.5 mL/dose IM.

0.5 mL/dose IM.

0.5 mL/dose IM.

< 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.

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.

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]