Clinical trials in the United States and Japan with the Lederle-Takeda and Takeda acellular pertussis-diphtheria-tetanus (APDT) vaccines. The Multicenter APDT Vaccine Study Groups

Dev Biol Stand. 1991:73:51-8.

Abstract

The results of the following studies are reported: a longitudinal double blind trial comparing Lederle-Takeda APDT vaccine with Lederle DTP vaccine in two, four and six month old infants; two double blind similar APDT vs DTP trials in 18 month old and four to six year old children; a large longitudinal open trial with APDT in two, four and six month old infants and a household contact efficacy trial with Takeda APDT in Japan. APDT vaccine recipients had a lesser frequency and less severe reactions than whole cell vaccine recipients. Antibody responses to lymphocytosis-promoting factor and agglutinogens were higher in DTP recipients; APDT recipients had a better serologic response to filamentous hemagglutinin. Equivalent 69K protein antibody responses were seen. Vaccine efficacy in the household contact study was 98% (95% CI = 84% to 99%) against classical pertussis and 81% (95 CI = 64% to 90%) if all respiratory illnesses are considered.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antibodies, Bacterial / blood
  • Child
  • Child, Preschool
  • Diphtheria-Tetanus-Pertussis Vaccine / adverse effects
  • Diphtheria-Tetanus-Pertussis Vaccine / isolation & purification
  • Diphtheria-Tetanus-Pertussis Vaccine / pharmacology*
  • Double-Blind Method
  • Humans
  • Infant
  • Japan
  • Longitudinal Studies
  • United States
  • Whooping Cough / prevention & control

Substances

  • Antibodies, Bacterial
  • Diphtheria-Tetanus-Pertussis Vaccine