ACTHIB

General Administration Information
For storage information, see the specific product information within the How Supplied section.

-Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. These actions are required by the National Childhood Vaccine Injury Act of 1986.
-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.

Route-Specific Administration

Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
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). 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.

Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as to the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

Of 365 infants who received Haemophilus influenzae type b (Hib) conjugate vaccine concomitantly with whole-cell DTP vaccine at separate sites at 2, 4, and 6 months of age, diarrhea, vomiting, and anorexia occurred. Anorexia frequency decreased with increasing age, with 4.9-15.3% and 2.2-5.5% of infants 2 months and 6 months of age experiencing decreased appetite, respectively. Diarrhea occurred in 3.6-6.6% of infants, and vomiting occurred in 1.9-4.1% of infants. When Hib vaccine was administered with DTaP in a US safety study of children 15-20 months of age, anorexia and vomiting were observed up to 48 hours post-dose, with anorexia occurring in up to 12.7% of children and vomiting in up to 0.9%. Diarrhea and vomiting have also been observed in multicenter clinical studies involving 678 infants who received Hib vaccine during a primary immunization series. Of 371 children with a mean age of 16 months who were vaccinated with 1 booster dose of Hib vaccine (Hiberix) concomitantly with DTaP-HBV-IPV vaccine, 22.9% had anorexia, 14.6% had diarrhea, and 4.9% had vomiting within 4 days of vaccination. Counsel patients to report signs or symptoms of a systemic reaction to their health care provider.

Post-marketing adverse drug reactions (ADRs) with the Haemophilus influenzae type b conjugate vaccine include but are not limited to anaphylactic shock, anaphylactoid reactions, angioedema, urticaria, erythema multiforme, rash (unspecified), Guillain-Barre syndrome, lymphadenopathy, hypotonia, and seizures. As with most post-marketing adverse reactions, causality and incidence are uncertain.

During clinical trials, drowsiness was frequently reported in 2.5-57.5% of infants when Haemophilus influenzae type b (Hib) conjugate vaccine was administered concurrently with various whole-cell DTP or DTaP vaccines. Sleepiness was reported by 19.9% of children following 1 booster dose of Hib vaccine (Hiberix). Seizures have rarely been reported in patients who receive Hib vaccines. In a randomized, double-blind trial of 5000 infants, 2 definite and 3 possible seizures were observed after Hib vaccine was administered concomitantly with whole-cell DTP vaccine; this rate of seizures is not greater than that previously reported in infants who received DTP vaccine alone. Febrile seizures have been observed during post-marketing surveillance of Hib vaccines, along with hypotonia (hypotonic-hyporesponsive episodes), Guillain-Barre syndrome, and syncope or vasovagal responses to injection. Syncope may be accompanied by visual disturbances, paresthesias, and tonic-clonic limb movements; have procedures in place to avoid falling injuries.

Fever was frequently reported when Haemophilus influenzae type b (Hib) conjugate vaccine was administered concurrently with whole-cell DTP or DTaP vaccines to infants and children during clinical trials. Fever > 100.8 degrees F occurred in 0.6-20.1% of infants who received Hib vaccine and whole-cell DTP, and fever > 102.2 degrees F was observed in up to 1.9% of 15-20 month old children during observations for 48 hours after vaccination with Hib and DTaP vaccines. Of 222 infants vaccinated with Hib vaccine at 2-6 months of age, 0.5-18.1% experienced fever >= 101 degrees F; whole-cell DTP and OPV vaccines were given concomitantly to most infants. Fever >= 100.4 degrees F was observed in 34.8% of children following 1 booster dose of Hib vaccine (Hiberix) given with DTaP-HBV-IPV vaccine. Of 475 infants and children ages 2-20 months who were immunized with Hib vaccine concurrently with DTP or DTaP vaccines, irritability was observed in 10.1-72.6%. Restlessness (21.8%) and fussiness (25.9%) were noted among 371 children (mean age of 16 months) given 1 booster dose of Hib vaccine (Hiberix) with DTaP-HBV-IPV vaccine. Grade 3 fussiness (defined as persistent crying that could not be comforted) occurred in 0.8% of children. Other trials during which Hib vaccine was given with whole-cell DTP vaccine reported inconsolable crying among 0.3-1.6% of infants. During post-marketing experience, high pitched crying has been observed. Instruct patients to report any signs of symptoms of a systemic reaction.

Haemophilus influenzae type b (Hib) conjugate vaccine is generally well tolerated. The most common adverse reactions are local reactions (i.e., injection site reaction) consisting of erythema and induration with or without tenderness. Among infant Hib vaccine recipients aged 2-6 months in various clinical trials, 0.3-14.3% had erythema, 0.8-22.5% had induration, 0-3.6% had swelling, and 1.1-46.3% had tenderness at the injection site within 2 days following immunization. Among children aged 15-20 months who received 1 booster dose of a Hib vaccine (n = 481), 0-24.5% had erythema, 0.9-5.5% had induration, 0-14.8% had swelling, and 0.9-20% had tenderness at the injection site within 2-4 days following immunization. In a clinical trial of 371 children with a mean age of 16 months, 20.5% reported pain at the injection site within 4 days of immunization. Extensive swelling of the vaccinated limb and sterile injection site abscess have been reported during post-marketing observation. Local reactions are usually self-limiting and do not require therapy; most resolve within 48 hours after immunization.

Infectious events reported during clinical trials of Haemophilus influenzae type b conjugate vaccine included otitis media, upper respiratory infection, and bilateral pneumonia; drug causality is not established. Tracheitis was reported during a trial of the lyophilized formulation of PedvaxHIB, which was possibly related to the vaccine. Additionally, lymphadenopathy has been observed during post-marketing surveillance.

One case of thrombocytopenia in an infant was reported during clinical trials with Haemophilus influenzae type b conjugate vaccine. Vaccine causality is not established.

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.

Apnea has been reported after administration of intramuscular vaccines to premature infants. For infants born prematurely, consider the infant's medical status and the potential benefits and possible risks of vaccination when deciding when to administer any intramuscular vaccine, including the Haemophilus influenzae type b conjugate vaccine.

Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of Haemophilus influenzae type b conjugate vaccine has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

The Haemophilus influenzae type b conjugate vaccine is only indicated for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration. Incorrect administration may result in inadequate immunity.

Haemophilus influenzae type b conjugate vaccine is contraindicated in patients who have had an immediate anaphylactic reaction temporally associated with a previous dose of this vaccine or any of its components; Hiberix and ActHIB vaccines are specifically contraindicated in patients with a previous severe allergic reaction to a tetanus toxoid-containing vaccine. PedvaxHIB should also be used with caution in patients with Neisseria meningitidis vaccine hypersensitivity. Caution is advised in patients with latex hypersensitivity as 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. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. Epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis should be immediately available in the event of a serious allergic reaction to the vaccine. If immunizations are to be considered in a patient with a history of a severe allergic reaction to the vaccine or a component of the vaccine, referral of the potential vaccine recipient to an allergist may be appropriate.

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. Additionally, apnea has been observed in some premature neonates administered intramuscular vaccines. For infants born prematurely, consider the infant's medical status and the potential benefits and possible risks of vaccination when deciding when to administer an intramuscular vaccine.

Patients with significant immunosuppression may not have an adequate antibody response to Haemophilus influenzae type b conjugate vaccine. Immunosuppressed persons may include patients with human immunodeficiency virus (HIV) infection; severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). 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 recommends that vaccinations be delayed during the course of a moderate or severe acute febrile illness and administered after the acute phase of illness has resolved. 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.

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.

For Native American patients and Alaska natives, Haemophilus influenzae type b meningitis peaks at a younger age (4 to 6 months) as compared to other US infant population (6 to 7 months). 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 it produces a protective antibody response after the first dose. 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 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 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.

Description: 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.

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):
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.
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 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.
Children 12 to 14 months of age at first dose: 0.5 mL IM for 2 doses administered 8 weeks apart.
Children 15 to 18 months of age at first dose: 0.5 mL IM once.
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 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.
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 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.
Intramuscular dosage (Liquid PedvaxHIB):
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.
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).
Children 12 to 14 months of age at first dose: 0.5 mL IM for 2 doses 8 weeks apart.
Children 15 months to 5 years: 0.5 mL IM once (if previously unvaccinated).
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 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.
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 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.
Intramuscular dosage (Hiberix):
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 12 to 15 months of age per ACIP recommendations or at 15 to 18 months per the FDA-approved product label.
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.
Children 12 to 14 months of age at first dose: 0.5 mL IM for 2 doses administered 8 weeks apart.
Children 15 to 59 months (previously unvaccinated): 0.5 mL IM once (if previously unvaccinated).
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 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.
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 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.

Maximum Dosage Limits:
-Neonates
Use not recommended.
-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.
-Children
0.5 mL IM
-Adolescents
0.5 mL IM.

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. However, consult current immunization schedules for recommended vaccines for use in young dialysis patients; the ACIP states that all routine vaccinations are likely effective in patients with chronic renal disease.

*non-FDA-approved indication

Monograph content under development

Mechanism of Action: Haemophilus influenzae type b conjugate vaccine confers immunity against Haemophilus influenzae type b (Hib) bacteria.

Haemophilus influenzae type b conjugate 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 vaccines contain the capsule polysaccharides from Hib bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis or to tetanus toxoid. Haemophilus b conjugate vaccine exposure stimulates the immune system to produce Hib capsule-specific antibodies (anti-PRP) that makes 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. Antibodies to the Hib bacterium polysaccharide capsule (anti-PRP) may not be detectable until 2 weeks after the last recommended dose. In some individuals, immune response to the vaccine may not be sufficient to provide protection against Haemophilus influenzae type b infection. Pharmacokinetics of the vaccine are not well defined.


-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 3.64-6.37, with 83-97% of infants developing a concentration >= 1 mcg/ml (a concentration considered indicative of long-term protection). In a trial of Native American children, following 3 doses of ActHIB at 6 weeks, 4 months, and 6 months of age, 75% developed anti-PRP antibody titers >= 1 mcg/ml. In previously unvaccinated children 12-24 months of age who received 1 dose of ActHIB, 90% of those 12-15 months and 82% of those 17-24 months developed anti-PRP antibody titers >= 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 >= 1 mcg/ml in 89%. In a randomized clinical study involving 903 infants 2-6 months of age who received PedvaxHIB, 80% of infants developed anti-PRP titers >= 1 mcg/ml after a primary 2 dose regimen. After booster immunization at 12-15 months, 95% developed titers > 1 mcg/ml. The immune response to Hiberix was evaluated in children 16-23 months of age who received the booster vaccine following a primary immunization series with Hib. Post-immunization, 97.6-100% of children developed anti-PRP titers >= 1 mcg/ml.