Pediarix

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Pediarix Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; hepatitis B vaccine (recombinant), aluminum phosphate adsorbed; inactivated polio vaccine; susp for IM inj; preservative-free; contains traces of formaldehyde, yeast protein, neomycin, polymyxin B, polysorbate 80; preservative-free.

    Pharmacological Class

    DTaP + HB + IPV.

    How Supplied

    Single-dose prefilled syringes—10

    Storage

    Store refrigerated between 2º and 8º C (36º and 46º F). Do not freeze. Discard if the vaccine has been frozen.

    Manufacturer

    GlaxoSmithKline

    Generic Availability

    NO

    Mechanism of Action

    Protection against diphtheria is due to the development of neutralizing antibodies to the diphtheria toxin. Protection against tetanus is due to the development of neutralizing antibodies to the tetanus toxin. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Antibody concentrations ≥10mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection. Poliovirus-neutralizing antibodies confer protection against poliomyelitis disease.

    Pediarix Indications

    Indications

    Immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis in infants age 6 weeks through 6 years of age (before 7th birthday) born of HBsAg-negative mothers.

    Pediarix Dosage and Administration

    Adult

    Not recommended.

    Children

    Each dose is 0.5mL IM into the anterolateral aspect of the thigh (for <12 months of age) and the deltoid (for older children). Give 1st dose preferably at 2 months of age (may give as early as 6 weeks of age); then give 2nd dose 6–8 weeks later; then give 3rd dose 6–8 weeks later (preferably 8 weeks between doses). Previously vaccinated with one or more doses of individual components: see full labeling. Not for use as booster dose.

    Children

    Recommended Dose and Schedule

    • Each dose is 0.5mL IM into the anterolateral aspect of the thigh (for <12 months of age) and the deltoid (for older children).

    • Give 3 doses of 0.5mL each by IM injection at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks). May give the first dose as early as 6 weeks of age.

    Modified Schedules in Previously Vaccinated Children

    • Children Previously Vaccinated with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP)

      • May use Pediarix to complete the first 3 doses of the DTaP series in children who received 1 or 2 doses of Infanrix and are also scheduled to receive the other vaccine components of Pediarix.

    • Children Previously Vaccinated with Hepatitis B Vaccine

      • May use Pediarix to complete the hepatitis B vaccination series after 1 or 2 doses of another hepatitis B vaccine (monovalent or as part of a combination vaccine), including vaccines from other manufacturers, in children born of HBsAg-negative mothers who are also scheduled to receive the other vaccine components of Pediarix.

      • May give a 3-dose series of Pediarix to infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth. There is limited safety data of Pediarix in these infants.

    • Children Previously Vaccinated with Inactivated Poliovirus Vaccine (IPV)

      • May use Pediarix to complete the first 3 doses of the IPV series in children who received 1 or 2 doses of IPV from a different manufacturer and are also scheduled to receive the other vaccine components of Pediarix.

    Booster Immunization following Pediarix

    • Children who have received a 3-dose series with Pediarix should complete the DTaP and IPV series according to the recommended schedule.

    • Children should receive Infanrix as their fourth dose of DTaP and either Infanrix or Kinrix as their fifth dose of DTaP, according to the respective prescribing information for these vaccines.

    • Kinrix or another manufacturer’s IPV may be used to complete the 4-dose IPV series according to the respective prescribing information.

    Pediarix Contraindications

    Contraindications

    Anaphylaxis associated with previous dose. Encephalopathy within 7 days after previous pertussis-containing vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    Contraindications

    Hypersensitivity

    • Severe allergic reaction (eg, anaphylaxis) associated with previous diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis B-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin B.

    Encephalopathy

    • Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause.

    Progressive Neurologic Disorder

    • Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    • Do not administer Pediarix to individuals with these conditions until the neurologic status is clarified and stabilized.

    Pediarix Boxed Warnings

    Not Applicable

    Pediarix Warnings/Precautions

    Warnings/Precautions

    Guillain-Barre syndrome within 6 weeks of previous tetanus toxoid-containing vaccine. Fever (≥105°F within 48hrs), persistent inconsolable crying (≥3hrs within 48hrs), shock (within 48hrs), or seizures (within 3 days) after previous DTaP or DTwP vaccine: see full labeling. Seizure risk (may give antipyretic). Bleeding disorders. Have epinephrine available. Latex allergy (syringes). Immunodeficiency. 

    Warnings/Precautions

    Fever

    • Higher rates of fever relative to separately administered vaccines have been reported after administration of Pediarix in clinical trials.

    Guillain-Barré Syndrome

    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous vaccine containing tetanus toxoid, the decision to give Pediarix should be based on careful consideration of the potential benefits and possible risks. 

    • Other available vaccines should be given as indicated if administration of tetanus toxoid is withheld.

    Latex

    • The tip caps of the prefilled syringes contain natural rubber latex and may cause allergic reactions.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting and to restore cerebral perfusion after syncope.

    Adverse Reactions following Prior Pertussis Vaccination

    • Carefully consider the potential benefits and possible risks of administering Pediarix if any of the following events occur after administration of a pertussis-containing vaccine:

      • Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause. 

      • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours. 

      • Persistent, inconsolable crying lasting at least 3 hours within 48 hours. 

      • Seizures with or without fever within 3 days.

    Children at Risk for Seizures

    • Increased risk of seizure in children at the time of vaccination with a pertussis-containing vaccine (including Pediarix) and for the following 24 hours after; may administer appropriate antipyretic to reduce the possibility of post-vaccination fever. 

    Apnea in Premature Infants

    • Risk of apnea has been observed in some infants born prematurely.

    • Consider the individual infant’s medical status and the potential benefits and risks of vaccination when deciding to administer Pediarix to infants born prematurely.

    Preventing and Managing Allergic Vaccine Reactions

    • Have epinephrine and other appropriate agents immediately available in case an acute anaphylactic reaction occurs.

    • Review the patient’s immunization history for hypersensitivity prior to administration.

    Pediatric Considerations

    Safety and effectiveness of Pediarix in infants younger than 6 weeks and children aged 7 to 16 years have not been evaluated.

    Pediarix Pharmacokinetics

    See Literature

    Pediarix Interactions

    Interactions

    Concomitant vaccines: see literature. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

    Interactions

    Concomitant Vaccine Administration

    • In a clinical trial, the immune responses were evaluated for the concomitant administration of Pediarix with Hib conjugate vaccine and 7-valent pneumococcal conjugate vaccine.

    • Use separate syringes and at different injection sites when administering Pediarix with other injectable vaccines.

    Immunosuppressive Therapies

    • Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may reduce the immune response to Pediarix.

    Pediarix Adverse Reactions

    Adverse Reactions

    Local reactions (pain, redness, swelling), irritability/fussiness, fever, crying, drowsiness, loss of appetite; rare: seizure, anaphylaxis.

    Pediarix Clinical Trials

    Clinical Trials

    The efficacy of the pertussis component of Pediarix, which does not have a well-established correlate of protection, was determined in clinical trials of Infanrix.

    Efficacy of Infanrix - For additional details see Infanrix monograph or prescribing information

    • 2 clinical studies evaluated the efficacy of Infantrix as a 3-dose primary series.

    • In a double-blind, randomized, active Diphtheria and Tetanus Toxoids (DT)-controlled trial conducted in Italy, the absolute protective efficacy of Infanrix was assessed when administered at 2, 4, and 6 months of age. Infants were randomly assigned to receive Infanrix (n=4,481) or DT vaccines (n=1,470). The mean length of follow-up was 17 months beginning 30 days after the third dose of the vaccine.

      • The absolute protective efficacy of Infanrix against WHO-defined typical pertussis (21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing) was 84% (95% CI, 76-89) after 3 doses.

      • When the definition of pertussis was expanded to include clinically milder disease with respect to type and duration of cough, with infection confirmed by culture and/or serologic testing, the efficacy of Infanrix was 71% (95% CI, 60-78) against more than 7 days of any cough and 73% (95% CI, 63-80) against at least 14 days of any cough.

      • In a follow-up period from 24 months to a mean age of 33 months, the efficacy of Infanrix against WHO-defined pertussis was 78% (95% CI, 62-87).

      • In a third follow-up period in children aged 3 to 6 years, the efficacy of Infanrix against WHO-defined pertussis was 86% (95% CI, 79-91).

    • In a prospective efficacy trial conducted in Germany employing a household contact study design, 3 doses of Infanrix was administered at 3, 4, and 5 months of age in more than 22,000 children. Infants who did not participate in the study could have received a DTwP or DT vaccine. Calculation of vaccine efficacy was based on attack rates of pertussis in household contacts.

      • Among 173 contacts who did not receive a pertussis vaccine, 96 developed WHO-defined pertussis vs 7 of 112 contacts vaccinated with Infanrix. The protective efficacy of Infanrix was 89% (95% CI, 77-95).

      • When the definition of pertussis was expanded to include clinically milder disease with infection confirmed by culture and/or serologic testing, the efficacy of Infanrix was 67% (95% CI, 52-78) against at least 7 days of any cough and 81% (95% CI, 68-89) against at least 7 days of paroxysmal cough. The corresponding efficacy of Infanrix was 73% (95% CI, 59-82) against at least 14 days of any cough and 84% (95% CI, 71-91) against at least 14 days of paroxysmal cough.

    Immunological Evaluation of Pediarix

    • A US multicenter study evaluated infants who were randomly assigned to 1 of 3 groups:  

      • (1) Combination vaccine group – Pediarix concomitantly with Hib conjugate vaccine (Wyeth Pharmaceuticals Inc.; no longer licensed in the US) and US-licensed 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.); 

      • (2) Separate vaccine group – US-licensed Infanrix, Engerix-B, and IPV (Sanofi Pasteur SA) concomitantly with the same Hib and pneumococcal conjugate vaccines; and 

      • (3) Staggered vaccine group – Pediarix concomitantly with the same Hib conjugate vaccine but with the same pneumococcal conjugate vaccine administered 2 weeks later.

    • Pediarix in the combination vaccine group achieved noninferiority to the separate vaccine group for GMCs adjusted for pre-vaccination values for PT, FHA, and pertactin and the seroprotection rates for diphtheria, tetanus, and the polioviruses. 

    Pediarix Note

    Not Applicable

    Pediarix Patient Counseling

    Patient Counseling

    Provide the following information to the parent or guardian: 

    • Inform of the potential benefits and risks of immunization with Pediarix, and of the importance of completing the immunization series. 

    • Inform about the potential for adverse reactions that have been temporally associated with administration of Pediarix or other vaccines containing similar components. 

    • Instruct to report any adverse events to their healthcare provider. 

    • Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

    • Latest News Your top articles for Wednesday

    • Haymarket Medical NetworkTop Picks

    • Loading...

      Continuing Medical Education (CME/CE) Courses

      Show More