Infanrix

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  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Infanrix Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diphtheria and tetanus toxoids, acellular pertussis vaccine; aluminum hydroxide adsorbed; susp for IM inj; preservative-free; contains traces of formaldehyde, polysorbate 80.

    Pharmacological Class

    DTaP.

    How Supplied

    Single-dose vials—10; Single-dose prefilled Tip-Lok syringe—5 (without needles)

    Storage

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

     

    Manufacturer

    GlaxoSmithKline

    Mechanism of Action

    Protection against disease is due to the development of neutralizing antibodies to the diphtheria toxin. Protection against disease 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.

    Infanrix Indications

    Indications

    Diphtheria, tetanus, and pertussis immunization in infants and children 6 weeks through 6 years of age (before 7th birthday).

    Infanrix 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 of the upper arm (for ≥12 months to 6yrs of age). Primary series: Give 1st dose preferably at 2 months of age (may give as early as 6 wks of age); then give 2nd dose 4–8 wks later, then give 3rd dose 4–8 wks later, then give 4th dose at 15–20 months of age (6–12 months after 3rd dose); may give 5th dose at 4–6 yrs of age, unless 4th dose was given after 4th birthday. Or, may be used to complete a DTaP vaccination series initiated with Pediarix.

    Infanrix Contraindications

    Contraindications

    Anaphylaxis associated with any previous diphtheria, tetanus, pertussis vaccine. Encephalopathy within 7 days of a previous pertussis vaccine. Progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    Infanrix Boxed Warnings

    Not Applicable

    Infanrix Warnings/Precautions

    Warnings/Precautions

    Guillain-Barre syndrome within 6 weeks of previous tetanus vaccination. Fever (≥105°F within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), or seizures (within 3 days) after previous pertussis vaccine: see literature. Seizure risk: may give antipyretics. Latex allergy (prefilled syringes). Have epinephrine available. Pregnancy (Cat.C): not applicable.

    Warnings/Precautions

    Guillain-Barré Syndrome

    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including Infanrix, 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 Infanrix 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 Infanrix) 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.

    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 efficacy of Infanrix in infants <6 weeks of age and children aged 7 to 16 years have not been established.

    • Infanrix is not approved for use in these age groups.

    Infanrix Pharmacokinetics

    See Literature

    Infanrix Interactions

    Interactions

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

    Infanrix Adverse Reactions

    Adverse Reactions

    Local reactions, fever, irritability/fussiness, crying, drowsiness, loss of appetite, vomiting, diarrhea.

    Infanrix Clinical Trials

    Clinical Trials

    Diphtheria and Tetanus

    • The efficacy of diphtheria and tetanus toxoid used in Infanrix was based on immunogenicity studies.

    • A VERO cell toxin-neutralizing test confirmed the ability of infant sera (N =45), obtained 1 month after a 3-dose primary series, to neutralize diphtheria toxin. Levels of diphtheria antitoxin ≥0.01 IU/mL were achieved in 100% of the sera tested.

    • An in vivo mouse neutralization assay confirmed the ability of infant sera (N =45), obtained 1 month after a 3-dose primary series, to neutralize tetanus toxin. Levels of tetanus antitoxin ≥0.01 IU/mL were achieved in 100% of the sera tested.

    Pertussis

    • 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.

    Pertussis Immune Response to Infanrix Administered as a 3-Dose Primary Series

    • 3 clinical studies (1 Italian efficacy study; 1 US study; and 1 German study) evaluated the immune responses to each of the 3 pertussis antigens contained in Infanrix in sera obtained 1 month after the third dose of vaccine. 

    • One month after the third dose, the response rates to each pertussis antigen were similar in all 3 studies.

    Immune Response to Concomitantly Administered Vaccines

    • A US study evaluated the concomitant use of Infanrix with Hib conjugate vaccine at 2, 4, and 6 months of age. 

      • 90% of 72 infants had anti-PRP ≥1.0 mcg/mL one month after the third dose of Hib conjugate vaccine.

    • A US study evaluated the concomitant use of Infanrix with Engerix-B, IPV, PCV7, and Hib conjugate vaccines at 2, 4, and 6 months of age.

      • 99.2% of 121 patients who did not receive a birth dose of hepatitis B vaccine achieved anti-HBsAg ≥10 mIU/mL following the third dose of Engerix-B.

      • 100% of 153 patients achieved anti-poliovirus 1, 2, and 3, ≥1:8 following the third dose of IPV.

      • 91.8% to 99.4% of patients achieved anti-pneumococcal polysaccharide ≥0.3 mcg/mL for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 73.0% had a level ≥0.3 mcg/mL for serotype 6B after the third dose of PCV7 vaccine.

    Infanrix Note

    Notes

    Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.

    Infanrix Patient Counseling

    Patient Counseling

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

    • Inform about the potential for adverse reactions that have been temporally associated with administration of Infanrix 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).

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