PEDIARIX

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

-Inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the parent or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
-Record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine in the patient's permanent 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
-Use vaccine as supplied; reconstitution is not necessary.
-Shake pre-filled syringe vigorously just prior to administration to ensure a uniform, cloudy suspension. If the vaccine cannot be resuspended or if a gel-like substance is present, discard it.
-Do not mix with any other vaccine.
-Storage of unopened vials:-Manufacturer recommendations: Store refrigerated at 2-8 degrees C (36 to 46 degrees F); do not freeze.
-Off-label storage information: According to a 2007 published article, storage of Pediarix (GlaxoSmithKline) at room temperature for up to 24 hours is acceptable. NOTE: Because changes in vaccine formulation may affect stability and effectiveness, confirmation of acceptable duration of storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended.


Intramuscular (IM) Injection
-Choose an appropriate length needle for intramuscular administration.-For the majority of infants < 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.
-For children 1-2 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, the needle size required for deltoid injection ranges from 5/8- to 1-inch.

-Inject into the anterolateral aspect of the thigh (for infants < 1 year of age) or the deltoid muscle of the upper arm (usually suitable for older children). Do not administer in the gluteal muscle; gluteal administration has resulted in lower hepatitis B seroconversion rates. Of note, deltoid administration has been associated with a higher risk of local reactions to the DTaP vaccine that required medical attention in children 1-2 years of age.
-When concomitant administration of other vaccines or immunoglobulin is required, they should be given 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.

During 14 clinical trials with diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix), 2 cases of sudden infant death syndrome (SIDS) were reported. The Institute of Medicine and other experts reviewed available data and found no evidence of a causal relationship between DTaP vaccination and SIDS.

The most common adverse reactions to the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix) include injection site reaction (usually erythema, swelling, and tenderness). Among recipients of Pediarix administered concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine, 24.9-40.1% had redness, 31.2-36.1% had pain, and 17.3-28.7% had swelling at the injection site. Injection site reactions (including cellulitis, induration, itching, nodule/lump, pain, redness, swelling, and warmth at the site of injection), as well as limb pain or swelling, have been reported during the post-marketing surveillance program. Local reactions are usually self-limiting and do not require therapy. As with other vaccines that use aluminum as an adjuvant, a small nodule may be palpable at the vaccination site for several weeks. Persistent nodules have been reported after the use of adsorbed products. These nodules are likely due to poor IM administration technique. The nodule is usually not associated with pain, is self limited, and does not require therapy.

After intramuscular vaccination with the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix), apnea has been observed in some infants born prematurely. 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. In a US safety study, 4 cases of bronchiolitis were reported among 673 subjects who received Pediarix with concomitant Hib and pneumococcal conjugate vaccines compared to 3 cases in those that received individual vaccine components (Infanrix, Engerix-B, and IPV) (n = 335) with the concomitant vaccines. Dyspnea, cough, and apnea have been reported during post-marketing experience.

Among recipients of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix) administered concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine during a cohort safety study, 27.9-38.8% experienced fever of at least 100.4 degrees F. In clinical trials, administration of Pediarix was associated with significantly higher rates of fever, relative to separately administered vaccines (19.8-30.2%, p < 0.05). The prevalence of fever appears to be highest on the day of vaccination and the following day. The majority of episodes of fever (> 96%) resolved within the 4-day period after vaccination. During a post-marketing safety surveillance study that included 22,500 doses, 0.27% of patients experienced medically-attended fever, defined as fever > 100.4 degrees F that resulted in hospitalization, emergency department visit, or outpatient visit. Fever of 40.5 degrees C (105 degrees F) or higher not attributable to other causes and occurring within 48 hours of immunization is thought to be related to the pertussis component of the vaccine. Convulsions associated with high fever have been reported.

Seizures have been reported after immunization, which, like high fever, may be related to the pertussis component of the vaccine. Of 4666 patients who received Pediarix during a German safety study, 6 developed seizures (including febrile and afebrile types), corresponding to a rate of 0.22 per 1000 doses; 2 subjects experienced seizures within 1 week of immunization. No subjects who received concomitant Infanrix, Hib vaccine, and OPV (n = 768) reported seizures. During a US study, 4 of 673 subjects who received Pediarix administered concomitantly with Hib and 7-valent pneumococcal conjugate vaccines reported seizures, while 2 of 335 subjects who received Infanrix, Engerix-B, IPV, and Hib and 7-valent pneumococcal conjugate vaccines experienced seizures. No seizures occurred within 7 days of administration. Seizures are more likely to occur in children with a history of seizures or a family history of seizures. Among recipients of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix) administered concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine during a cohort safety study, 60.5-64.9% experienced irritability. Worldwide voluntary reports of serious adverse events with suspected causal connection received for Pediarix since market introduction include convulsions, depressed level of consciousness, febrile convulsion, hypotonia, hypotonic-hyporesponsive episode, insomnia, nervousness, restlessness, and screaming. Hypotonic-hyporesponsive episodes within 48 hours of administration or persistent, inconsolable crying for >= 3 hours (or high-pitched unusual screaming) occurring within 48 hours may be related to the pertussis component of the vaccine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Instruct patients to report any signs and symptoms of a fever or a systemic reaction. Children experiencing any serious reaction after Pediarix administration should be evaluated for the appropriateness of continuing Pediarix immunization versus completing immunization with DT toxoids and separately administered hepatitis B vaccine and poliovirus vaccine.

Drowsiness was among the most common adverse reactions to the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix). Among recipients of Pediarix administered concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine, 40.9-57.2% had drowsiness. Fatigue, lethargy, and depressed level of consciousness have been reported during post-marketing observation. Although a suspect causal relationship exists, definite causality and the frequency of occurrence is not established. Asthenia, malaise, arthralgia, arthritis, and myalgia have occurred during post-marketing surveillance with hepatitis B vaccine; therefore, these reactions may occur with Pediarix use.

A causal relationship between tetanus toxoid receipt and both brachial neuritis and Guillain-Barre syndrome appears to exist. If Guillain-Barre syndrome occurs within 6 weeks of receipt of a prior vaccine that contained tetanus toxoid, base the decision to give any vaccine containing tetanus toxoid such as diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix) on careful consideration of the potential benefits and possible risks, as the risk for Guillain-Barre syndrome may be increased. When a decision is made to withhold tetanus toxoid, administer other available vaccines, as indicated. Encephalopathy, meningitis, headache, neuritis, peripheral neuropathy, muscle paralysis, and muscular weakness have been reported with DTaP or the hepatitis B vaccine. Encephalopathy such as coma, decreased level of consciousness, or prolonged seizures within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine. Whole cell DTP (DTwP) was associated with acute encephalopathy in children. There are insufficient data at this time to determine if there is a causal association of encephalopathy with vaccines such as Pediarix that contain acellular DTP vaccines, or if the incidence is different from that of DTwP. The results of the National Childhood Encephalopathy Study (NCES) in England concluded that children 2 to 35 months of age who had histories of acute neurologic disorders were more likely to have received DTwP immunization within 7 days of the onset of the neurologic illness than controls. The incidence of these events is estimated at 1 per every 140,000 children vaccinated with DTwP. A follow-up study of the NCES 10 years later concluded that these affected cases were also more likely to have experienced chronic neurologic sequelae. The Advisory Committee on Immunization Practices (ACIP) evaluated the follow-up study and concluded that the data are insufficient to determine whether DTwP administration before the acute neurologic event influenced the potential for chronic neurologic dysfunction 10 years later. Subsequent studies have not been able to prove a causal relationship. Post-marketing, encephalitis and bulging fontanelle have been reported with Pediarix.

Anaphylactoid reactions, hypersensitivity, angioedema, erythema, rash (unspecified), and urticaria have been reported with post-marketing use of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine; recombinant; inactivated poliovirus vaccine, IPV (Pediarix). Other adverse reactions noted with DTaP or hepatitis B vaccines and, thus, could occur with Pediarix include anaphylactic shock, serum sickness-like disease, erythema multiforme, Stevens-Johnson syndrome, pruritus, lichen planus, and alopecia. As is the case with all voluntary reporting systems, such reports of adverse events do not necessarily indicate causality of the event. 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.

Anorexia may be noted after the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix). Among children who received Pediarix concomitantly with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine, 26.2-30.6% had anorexia. Post-marketing, diarrhea, vomiting, and elevated hepatic enzymes were reported. Other adverse reactions noted with DTaP or hepatitis B vaccines and, thus, could occur with Pediarix include abdominal pain, nausea, intussusception, and jaundice. As is the case with all voluntary reporting systems, such reports of adverse events do not necessarily indicate causality of the event.

Syncope has been reported post-marketing with the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix). 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. Cyanosis has also been observed during post-marketing surveillance.

Petechiae and pallor have been noted during post-marketing experience with the diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix). Adverse reactions noted with DTaP or hepatitis B vaccines and, thus, could occur with Pediarix include vasculitis, hemolytic anemia, thrombotic thrombocytopenic purpura (TTP), idiopathic thrombocytopenic purpura, thrombocytopenia, and lymphadenopathy. As is the case with all voluntary reporting systems, such reports of adverse events do not necessarily indicate causality of the event.

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 diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV 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.

Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV 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. This includes patients with yeast hypersensitivity, neomycin hypersensitivity, and polymyxin hypersensitivity. The tip caps of the prefilled syringes may contain dry natural latex rubber; thus, health care professionals should administer this vaccine with caution to patients with a history of latex hypersensitivity. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. Epinephrine (1:1000) 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 Guillain-Barre syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give subsequent doses of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

If any of the following occur in temporal relation to administration of a vaccine containing pertussis, the potential benefits and possible risks should be carefully considered when deciding to administer subsequent doses of diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV or other pertussis-containing vaccine: fever of >= 40.5 degrees C (105 degrees F) within 48 hours not due to another identifiable cause; collapse or shock like state (hypotonic-hyporesponsive episode) within 48 hours; persistent, inconsolable crying lasting >= 3 hours, occurring within 48 hours; and convulsions with or without fever occurring within 3 days. The decision to administer or to delay vaccination 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 given to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness.

Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV is contraindicated in patients who have experienced encephalopathy (coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another cause. The vaccine is also contraindicated in patients with a progressive neurological disease including infantile spasms, an uncontrolled seizure disorder, or progressive encephalopathy; do not administer the pertussis vaccine to patients with these conditions until a treatment regimen has been established and the condition has stabilized. The Advisory Committee on Immunization Practices (ACIP) recognizes that immunization with a vaccine containing DTaP in infants or children with stable neurological disease, including well-controlled seizures, may not be contraindicated. For children at higher risk of seizures than the general population, the ACIP recommends that acetaminophen or ibuprofen be administered at the time of vaccination and for 24 hours after to reduce the possibility of postvaccination fever.

Patients with significant immunosuppression may not have an adequate antibody response to diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV. 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.

The diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV is indicated for intramuscular administration. Therefore, the vaccine 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 for bleeding at IM injection sites. Steps to avoid hematoma are recommended.

Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV is only indicated for intramuscular administration; do not give via intravenous administration, subcutaneous administration, or intradermal administration. Incorrect administration may result in inadequate immunity.

In some premature neonates, apnea after intramuscular vaccination has been observed. Consider the infant's medical status and the vaccine's potential benefits and possible risks when deciding when to administer an intramuscular vaccine such as diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine (DTaP); hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV to infants born prematurely.

Safety and efficacy of the diphtheria/tetanus toxoid, acellular pertussis vaccine (DTaP); hepatitis B vaccine, recombinant; inactivated poliovirus vaccine (IPV) have not been established in neonates and infants < 6 weeks of age.

Description: Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix) is a combination of 5 vaccines that are recommended for all children before the first birthday. The vaccine is indicated for use as a 3-dose series for immunization against diphtheria, tetanus, pertussis, all known subtypes of hepatitis B, and poliomyelitis in infants born of hepatitis B surface antigen negative mothers. The administration of combination vaccines such as Pediarix is believed to reduce cost and improve compliance to the recommended vaccination schedule by reducing the number of injections received per physician visit. The pertussis antigens in Pediarix are the same as those found in Infanrix and Kinrix; therefore, Infanrix should be used for the fourth dose of DTaP and either Infanrix or Kinrix should be used for the fifth DTaP dose in children who receive the 3-dose series with Pediarix. Kinrix or another manufacturer's IPV may be used to complete the 4-dose IPV series. In 1997, adverse reactions associated with the use of whole-cell pertussis vaccines (DTP) led to recommendations by the Advisory Committee on Immunization Practices (ACIP) that acellular pertussis vaccines (DTaP) be used for routine childhood vaccination in the United States. In 2000, the ACIP recommended that IPV be used for routine childhood polio vaccination in the United States instead of oral poliovirus vaccine (OPV), prompted in part by the rare but serious side-effect of OPV-associated paralytic poliomyelitis. Pediarix is FDA-approved for use in infants as young as 6 weeks; ideally, administration should occur at 2, 4, and 6 months of age.

General dosing information:
-Pediarix may be used to complete the hepatitis B vaccination series in infants and children who previously received 1-2 doses of hepatitis B vaccine (monovalent or as part of a combination), regardless of the manufacturer of the previous vaccine. A 3-dose series of Pediarix may be given to infants born to hepatitis B surface antigen (HBsAg) negative mothers who received a dose of hepatitis B vaccine shortly after birth; the use of 3 doses of Pediarix in those who have received > 1 hepatitis B vaccine has not been evaluated.
-Infants born to mothers with HBsAg positive or unknown status should receive Hepatitis B vaccine within 12 hours of birth and complete the Hepatitis B vaccine series according to the schedule recommended by the Advisory Committee on Immunization Practices and the manufacturer.
-Pediarix is not recommended for completion of the first 3 doses of the DTaP vaccination series if the series was initiated with a DTaP vaccine from a different manufacturer.
-Pediarix may be used to complete the first 3 doses of the IPV series in infants who have received 1-2 doses of IPV, even if the initial IPV was from a different manufacturer.
-Pediarix is not indicated for use beyond 3 doses in the DTaP and IPV vaccination series; use of DTaP and IPV vaccines from the same manufacturer are recommended for full series completion. Do not use Pediarix as a booster vaccination.

For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, hepatitis B prophylaxis, and poliovirus prophylaxis for primary immunization:
Intramuscular dosage:
Neonates and Infants < 6 weeks: Not recommended.
Infants >= 6 weeks and Children < 7 years: 0.5 mL IM at intervals of 6 to 8 weeks (preferably 8 weeks) for 3 doses, ideally given at 2, 4, and 6 months of age. Although the first dose is recommended at 2 months of age, it may be given as early as 6 weeks; the vaccine may be used up to the seventh birthday.

Maximum Dosage Limits:
-Neonates
Not recommended.
-Infants
< 6 weeks: Not recommended.
>= 6 weeks: 0.5 ml/dose IM.
-Children
1-6 years: 0.5 ml/dose IM.
>= 7 years: Safety and efficacy have not been established.
-Adolescents
Safety and efficacy have not been established.

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: Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix) confers immunity against the bacteria that cause diphtheria, tetanus, pertussis (whooping cough), as well as the viruses that cause hepatitis B and polio.

Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP: Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, an extracellular protein metabolite of toxogenic strains of C. diphtheriae. Diphtheria toxoid induces the production of neutralizing antibodies against the exotoxin. A serum diphtheria antitoxin concentration of at least 0.1 international units/ml is considered protective.
Exotoxin release by C. tetani causes the neuromuscular dysfunction associated with tetanus. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin. A serum tetanus antitoxin concentration of at least 0.1 international units/ml is considered protective.
Pertussis, or whooping cough, is a highly communicable disease of the respiratory tract caused by Bordetella pertussis infection. The acellular pertussis vaccine contains different pertussis antigens (e.g., filamentous hemagglutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components. A serological concentration indicative of protection against pertussis has not been established.

Hepatitis B Vaccine, recombinant: Immunization with hepatitis B vaccine stimulates the immune system to produce anti-hepatitis B surface antigen antibodies without exposing the patient to the risks of active infection. An antibody concentration of at least 10 milli-international units/ml is considered protective. Infection with hepatitis D can occur only with concurrent hepatitis B infection, therefore, vaccination with recombinant hepatitis B vaccine provides protection against hepatitis D as well.

Inactivated poliovirus vaccine, IPV: Immunization with inactivated poliovirus vaccine (IPV) stimulates the immune system to produce neutralizing anti-poliovirus antibodies against each of the 3 poliovirus serotypes (Types 1, 2, and 3).

Pharmacokinetics: Diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine, DTaP; hepatitis B vaccine, recombinant; inactivated poliovirus vaccine, IPV (Pediarix) is administered intramuscularly. The pharmacokinetics of this vaccine are not well defined.


-Special Populations
Pediatrics
Infants 2-6 months
The immunogenicity of Pediarix was evaluated in infants who received the vaccine at 2, 4, and 6 months of age (n = 154-168), with comparison to individual vaccine components (administered as Infanrix, Engerix-B, and IPV) (n = 141-155). Subjects in both groups also received Hib and PCV7 vaccines. At 30 days after the last dose (range 20-60 days), immune responses to pertussis antigens (including pertussis toxin (PT), pertactin, and filamentous hemagglutinin (FHA)), diphtheria, tetanus, and poliovirus were non-inferior to those of the individual vaccine components. The following antibody responses were demonstrated: anti-diphtheria toxoid >= 0.1 international units/ml (99.4 % Pediarix vs. 98.7% individual vaccines), anti-tetanus toxoid >= 0.1 international units/ml (100% vs. 98.1%), anti-pertussis response of >= 5 ELISA units/ml in seronegative infants or at least maintenance of pre-vaccination concentration in seropositive infants, with anti-PT (98.7% vs. 95.1%), anti-FHA (98.7% vs. 96.5%), anti-pertactin (91.7% vs. 95.1%), and anti-polio types 1, 2, and 3 neutralizing antibody titer >= 1:8 (100% vs. 100% for all). Anti-hepatitis B surface antigen concentrations of >= 10 milli-international units/ml occurred in 97.7% and 99.2% of those immunized with Pediarix and Engerix-B, respectively. Non-inferiority of the hepatitis B component was not defined due to slight variations in hepatitis B immunization practices prior to enrollment; however, non-inferiority of Pediarix to Engerix-B has previously been established.