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PEDIARIX: clinical trials

Sylvia H Yeh1

  • 1UCLA Center for Vaccine Research, Los Angeles Biomedical Research Institute at Harbor-UCLA, 1124 W. Carson St, Liu Research Building, Torrance, CA 90502, USA. syeh@uclacvr.labiomed.org

Expert Review of Vaccines
|May 14, 2005
PubMed

Insights

PEDIARIX is the first pentavalent vaccine in the USA, offering protection against five diseases. This review examines its immunogenicity and safety data in infants.

Area of Science:

  • Pediatric infectious diseases
  • Vaccinology
  • Immunology

Background:

  • PEDIARIX is the first licensed pentavalent combination vaccine for infants in the USA.
  • It provides protection against diphtheria, tetanus, pertussis, hepatitis B, and poliovirus.

Purpose of the Study:

  • To review available data on the immunogenicity of PEDIARIX.
  • To review available data on the safety of PEDIARIX.

Main Methods:

  • Literature review of published and unpublished studies.
  • Analysis of clinical trial data.
  • Safety surveillance data review.

Main Results:

  • PEDIARIX demonstrated robust immunogenicity against all five antigens.
  • The safety profile of PEDIARIX was found to be acceptable.
  • Common adverse events were generally mild and transient.

Conclusions:

  • PEDIARIX is an effective and safe vaccine for infant immunization.
  • The pentavalent combination vaccine simplifies the infant immunization schedule.
  • Continued surveillance is important to monitor long-term safety and effectiveness.

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