Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX

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  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice
  • A total of 4,013 children were vaccinated with a single dose of KINRIX in 4 clinical trials. Of these, 381 children received a non-US formulation of KINRIX (containing ≤2.5 mg 2-phenoxyethanol per dose as preservative)
  • In a US randomized, controlled clinical trial, children 4 to 6 years of age were vaccinated with KINRIX or control vaccines (INFANRIX and IPOL® [inactivated poliovirus vaccine (IPV); Sanofi Pasteur SA])
    • KINRIX: N=3,156
    • INFANRIX and IPOL: N=1,053
    • Vaccination was as a fifth DTaP vaccine dose following 4 doses of INFANRIX and as a fourth dose of IPV following 3 doses of IPOL
    • All subjects also received the second dose of US-licensed measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.) concomitantly at separate sites
  • Adverse reactions collection
    • Data on adverse events were collected by parents/guardians using standardized forms for 4 consecutive days following vaccination with KINRIX or control vaccines (ie, day of vaccination and the next 3 days)
IPOL is a registered trademark of Sanofi Pasteur Limited.

 

The reported frequencies of solicited local reactions at the injection site for KINRIX or INFANRIX are shown in the following table.

  • KINRIX was non-inferior to INFANRIX with regard to swelling that involved >50% of the injected upper arm length and that was associated with a >30 mm increase in mid-upper arm circumference within 4 days following vaccination (upper limit of two-sided 95% confidence interval for difference in percentage of KINRIX [0.6%, n=20] minus INFANRIX [1.0%, n=11] ≤2%)

The reported frequencies of solicited local reactions and general adverse events are shown in the following table.

References

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814573R0 January 2017