Key Features of PEDIARIX


PEDIARIX may help ensure timely vaccination with fewer injections

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Pertussis: a vaccine-preventable disease on the rise[1,2]



Children who do not receive DTaP vaccine on time may be at risk [2]

Data from 1990 —1996:
Of 10,650 children 3 months to 4 years of age with pertussis
[2]

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Delays in protection are masked by national immunization coverage rates*[3,4]

A recent CDC study revealed significant vaccination delays in the first 2 years of life[4]

  • In this study, delays were counted beginning 1 full month following the maximum ACIP/AAP/AAFP§ recommended age for each immunization[4]
    —Included a delay in the receipt of 1 or more of the recommended doses of DTaP, IPV, MMR, Hib, Hep B, or varicella

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Constraints of multiple injections[5]

Likelihood of delays increased with the number of injections scheduled
*[5]

As more immunizations are added to the schedule, combination vaccines may help reduce the injection burden at vaccination visits.
[6]

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ACIP/AAP/AAFP preference for combination vaccines[6]:
   "The use of combination vaccines is preferred over separate injections
    of their equivalent component vaccines."
"To minimize the number of injections children receive, parenteral combination vaccines should be used, if licensed and indicated for patient's age, instead of their equivalent component vaccines."

Rationale: The use of licensed combination vaccines:
• is a practical way to overcome the constraints of multiple injections
• might improve timely vaccination coverage

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PEDIARIX may help ensure timely vaccination with fewer injections
5 serious childhood diseases—1 combination vaccine[7] –ACIP/AAP/AAFP recommendations state that administering 4 doses of Hep B,
as a part of a combination vaccine to complete a series is permissible
and not found to be harmful
[6,8]



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Proven immunogenicity

Antibody response similar to separately administered vaccines[7]

Data based on US Immunogenicity and Safety Study.[7,9]
*Percentage of infants who achieved a protective antibody level or vaccine response 1 month after administration of a third dose.
† Arrows represent a range of response rates to different antigens for pertussis and to neutralizing antibodies for 3 identified types of poliovirus.
‡ One month after the third dose of PEDIARIX, vaccine response rates for each of the pertussis antigens (with the exception of filamentous hemagglutinin [FHA]; geometric mean antibody concentrations for each of the pertussis antigens; and seroprotection rates for diphtheria, tetanus, hepatitis B, and the polioviruses were shown to be noninferior to those achieved following separately administered vaccines. The vaccine response to FHA marginally exceeded the 10% limit for noninferiority.
§ Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).

Administered concomitantlyll with a Hib conjugate vaccine (PRP-T)[7]


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Administer PEDIARIX with confidence

Proven safe in 12 clinical trials worldwide[7]
  • 20,739 doses administered to 7,028 infants

  • ** In a Harris Interactive survey of 1,053 moms.
    [12]
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    PEDIARIX is available in convenient Tip-Lok® prefilled syringes

    Each dose delivers DTaP, HepB, and IPV in 1 prefilled, prelabeled syringe

    • May help reduce the risk of medication errors
    • A liquid formulation—no mixing or reconstitution required
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    How is PEDIARIX Supplied?
      The following doses of PEDIARIX are supplied for pediatric patients:
    • 0.5 mL in Single-Dose Disposable Tip-Lok® Prefilled Syringes without needles
    • 0.5 mL in Single-Dose Vials
      See how Tip-Lok® streamlines the vaccination process

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    Important Safety Information

    In clinical studies, adverse events included injection-site reactions (pain, redness, or swelling), fever and fussiness for PEDIARIX and INFANRIX, and drowsiness for INFANRIX. As with other vaccines, rare adverse events may occur. Administration with PEDIARIX was associated with higher rates of fever relative to separately administered vaccines (see Adverse Reactions section of the package insert). PEDIARIX and INFANRIX are contraindicated in people with known hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B in PEDIARIX. As with any vaccine, vaccination may not protect 100% of susceptible individuals.


    Related Information:
    Key Features
    Frequently Asked Questions
    Important Safety Information
    Prescribing Information
    Material Safety Data Sheet

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        Key Features
        Frequently Asked Questions
        Important Safety Information
        Prescribing Information
        Material Safety Data Sheet

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