Unchanged efficacy of a pertussis toxoid vaccine throughout the two years after the third vaccination of infants

Pediatr Infect Dis J. 1997 Feb;16(2):180-4. doi: 10.1097/00006454-199702000-00003.

Abstract

Background: In a previously reported double blind efficacy trial of a pertussis toxoid vaccine, 3450 infants were randomized to receive diphtheria-tetanus toxoids with or without pertussis toxoid at 3, 5 and 12 months of age. Efficacy against pertussis as defined by the World Health Organization was 71% from 30 days after the third vaccination with an average follow-up of 17.5 months. We now report efficacy for an additional 6 months of open follow-up.

Methods: Parents were contacted monthly by a nurse. If a participant or a family member coughed for > or = 7 days, a nasopharyngeal sample and paired sera were obtained.

Results: Efficacy during this open follow-up period was 77% (95% confidence intervals, 66 to 85%) based on 29 and 110 cases fulfilling the WHO definition of pertussis in vaccinated and control children, respectively. Efficacy against household exposure was 76% (95% confidence intervals, 51 to 91%). Pertussis in vaccinated children had a significantly shorter duration than pertussis in control children. Determination of pertussis toxin antibodies in paired sera with enzyme-linked immunosorbent assay had a lower diagnostic sensitivity in vaccinated (45%) than in control (92%) children, while determination of antibodies against filamentous hemagglutinin (not included in the vaccine) was highly sensitive for diagnosing pertussis in both groups (100 and 90%, respectively).

Conclusions: A monocomponent pertussis toxoid vaccine induces significant protection against pertussis for at least 2 years after the third injection. To obtain an unbiased estimate of vaccine efficacy it is important to determine antibodies against an antigen that is not included in the vaccine.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Antibodies, Bacterial / biosynthesis*
  • Bordetella pertussis / immunology*
  • Bordetella pertussis / isolation & purification
  • Child, Preschool
  • Cohort Studies
  • Diphtheria Toxoid / administration & dosage
  • Diphtheria Toxoid / immunology
  • Diphtheria-Tetanus Vaccine
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
  • Diphtheria-Tetanus-Pertussis Vaccine / immunology*
  • Follow-Up Studies
  • Humans
  • Immunization Schedule
  • Infant
  • Nasopharynx / microbiology
  • Polymerase Chain Reaction
  • Randomized Controlled Trials as Topic
  • Tetanus Toxoid / administration & dosage
  • Tetanus Toxoid / immunology
  • Toxoids / immunology*
  • Vaccination
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / immunology

Substances

  • Antibodies, Bacterial
  • Diphtheria Toxoid
  • Diphtheria-Tetanus Vaccine
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Tetanus Toxoid
  • Toxoids
  • Vaccines, Combined
  • pertussis toxoid