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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Efficacy of INFANRIX Against Pertussis in a Clinical Trial "scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"[2]

  • Study design
  • Double-blind, randomized, active diphtheria and tetanus toxoids (DT)-controlled trial conducted in Italy
  • Assessed absolute protective efficacy of INFANRIX when administered at 2, 4, and 6 months of age
  • Mean length of follow-up 17 months (beginning 30 days after third vaccine dose)
  • Population used in primary analysis of efficacy
  • INFANRIX: N=4,481 infants
  • DT: N=1,470 infants

CI=confidence interval.
 

a 21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing.
b Any cough >7 days with infection confirmed by culture and/or serologic testing.
c Any cough ≥14 days with infection confirmed by culture and/or serologic testing.
  • After 3 doses, 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).
  • Efficacy of INFANRIX with an expanded definition of pertussis (clinically milder disease, with infection confirmed by culture and/or serologic testing) was 71% (95% CI: 60, 78) against >7 days of any cough and 73% (95% CI: 63, 80) against ≥14 days of any cough.

Protective Efficacy of INFANRIX in a Household Contact Study "scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"[2]

  • Study design
  • Prospective efficacy trial conducted in Germany employing a household contact study design
  • In preparation for this study, 3 doses of INFANRIX were administered at 3, 4, and 5 months of age to more than 22,000 children living in 6 areas of Germany in a safety and immunogenicity study
  • Infants who did not participate in the safety and immunogenicity study could have received a DTwP vaccine or DT vaccine
  • Index cases were identified by spontaneous presentation to a physician. Households with at least one other member (ie, besides index case) aged 6 through 47 months were enrolled
  • Household contacts of index cases were monitored for incidence of pertussis by a physician who was blinded to the vaccination status of the household
  • Vaccine efficacy was calculated based on attack rates of pertussis in household contacts classified by vaccination status

a 21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing.
b Infection confirmed by culture and/or serologic testing.
  • Of the 173 household contacts who had not received a pertussis vaccine, 96 developed WHO-defined pertussis, as compared with 7 of 112 contacts vaccinated with INFANRIX (protective efficacy of INFANRIX: 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 protective efficacy of INFANRIX against ≥7 days of any cough was 67% (95% CI: 52, 78), against ≥7 days of paroxysmal cough was 81% (95% CI: 68, 89), against ≥14 days of any cough was 73% (95% CI: 59, 82), and against ≥14 days of paroxysmal cough was 84% (95% CI: 71, 91).

1009622R0 September 2018