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Safety and reactogenicity of a low dose diphtheria tetanus acellular pertussis vaccine (Boostrix) in pre-school

A Bose1, A P Dubey, D Gandhi

  • 1Department of Community Health, Christian Medical College, Vellore, India.

Indian Pediatrics
|July 11, 2007
PubMed

Insights

The reduced-antigen Diphtheria Tetanus Acellular Pertussis (dTpa) vaccine is safe and well-tolerated in Indian preschool children, showing minimal adverse events during a two-week safety assessment.

Area of Science:

  • Immunology
  • Pediatric Vaccinology

Background:

  • The Diphtheria Tetanus Acellular Pertussis (dTpa) vaccine is crucial for pediatric immunization.
  • Evaluating reduced-antigen formulations is important for vaccine development and public health.

Purpose of the Study:

  • To assess the safety and reactogenicity of a reduced-antigen-content combined Diphtheria Tetanus Acellular Pertussis (dTpa) vaccine.
  • To evaluate this vaccine specifically in Indian preschool children.

Main Methods:

  • A single booster dose of the GlaxoSmithKline Biologicals dTpa vaccine was given to 347 Indian children aged 4-6 years.
  • Safety and reactogenicity were monitored for two weeks post-vaccination across seven study centers.

Main Results:

  • The study included 345 children, with two lost to follow-up. One unrelated serious adverse event (head injury) was reported.
  • Most adverse events were mild and transient, including injection site pain (31.1%), swelling (18.2%), and redness (8.9%).
  • Severe pain at the injection site occurred in 1.4% of subjects, resolving within 48 hours, with no severe local reactions.

Conclusions:

  • The reduced-antigen content combined dTpa vaccine demonstrates a favorable safety profile.
  • The vaccine is well-tolerated in the Indian preschool population, supporting its use.
Abstract

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