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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  • US multicenter study (Study 048)
    • 4,209 children 4 through 6 years of age who previously had received 4 doses of INFANRIX, 3 doses of inactivated poliovirus vaccine (IPV; Sanofi Pasteur SA), and 1 dose of measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.)
    • Randomized 3:1 to KINRIX or INFANRIX and IPV administered concomitantly at separate sites
    • All children were administered MMR
  • Immunological evaluation
    • Antibodies to the diphtheria, tetanus, pertussis (PT, FHA, and pertactin), and poliovirus antigens measured in sera obtained immediately prior to vaccination and 1 month (range 31 to 48 days) after vaccination
    • The co-primary immunogenicity endpoints were anti-diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses, and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs) 1 month after vaccination

The efficacy of the pertussis component of KINRIX was determined in clinical trials of INFANRIX administered as a 3-dose series in infants.

  • KINRIX was shown to be non-inferior to INFANRIX and IPV administered separately, in terms of booster responses to DTaP antigens
  • KINRIX was also shown to be non-inferior to INFANRIX and IPV administered separately, in terms of post-vaccination GMTs for anti-poliovirus antibodies

Anti-diphtheria toxoid and anti-tetanus toxoid booster responses are shown in the following table.



IPV=inactivated poliovirus vaccine (Sanofi Pasteur SA).
MMR=measles, mumps, and rubella vaccine (Merck & Co., Inc.).
ATP=according to protocol.
CI=confidence interval.
 
a One-month blood sampling; range 31 to 48 days.
b Coadministered with MMR vaccine (Study 048).
c Seroprotection defined as anti-diphtheria toxoid and anti-tetanus toxoid antibody concentrations ≥0.1 IU/mL by ELISA.
d Booster response: In subjects with pre-vaccination <0.1 IU/mL, post-vaccination concentration ≥0.4 IU/mL. In subjects with pre-vaccination concentration ≥0.1 IU/mL, an increase of at least 4 times the pre-vaccination concentration.
e KINRIX was non-inferior to INFANRIX + IPV based on booster response rates (upper limit of two-sided 95% CI on the difference of INFANRIX + IPV minus KINRIX ≤10%).

Anti-PT, anti-FHA, and anti-pertactin booster responses are shown in the following table.



IPV=inactivated poliovirus vaccine (Sanofi Pasteur SA).
MMR=measles, mumps, and rubella vaccine (Merck & Co., Inc.).
ATP=according to protocol.
CI=confidence interval.
 
a One-month blood sampling; range 31 to 48 days.
b Coadministered with MMR vaccine (Study 048).
c Booster response: In subjects with pre-vaccination <5 EL.U./mL, post-vaccination concentration ≥20 EL.U./mL. In subjects with pre-vaccination ≥5 EL.U./mL and <20 EL.U./mL, an increase of at least 4 times the pre-vaccination concentration. In subjects with pre-vaccination ≥20 EL.U./mL, an increase of at least 2 times the pre-vaccination concentration.
d KINRIX was non-inferior to INFANRIX + IPV based on booster response rates (upper limit of two-sided 95% CI on the difference of INFANRIX + IPV minus KINRIX ≤10%).

Post-vaccination GMTs for anti-poliovirus antibodies are shown in the following table.

Vaccination with KINRIX may not result in protection in all vaccine recipients.

References

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814573R0 January 2017