Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine

Vaccine. 2014 May 23;32(25):3019-24. doi: 10.1016/j.vaccine.2014.03.063. Epub 2014 Mar 31.

Abstract

Background: In 2008, a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combined vaccine (DTaP-IPV) was licensed for use in children 4 through 6 years of age. While pre-licensure studies did not demonstrate significant safety concerns, the number vaccinated in these studies was not sufficient to examine the risk of uncommon but serious adverse events.

Objective: To assess the risk of serious adverse events following DTaP-IPV vaccination.

Methods: The study was conducted from January 2009 through September 2012 in the Vaccine Safety Datalink (VSD) project. In the VSD, electronic vaccination and encounter data are updated and aggregated weekly as part of ongoing surveillance activities. Based on previous reports and biologic plausibility, eight potential adverse events were monitored: meningitis/encephalitis; seizures; stroke; Guillain-Barré syndrome; Stevens-Johnson syndrome; anaphylaxis; serious allergic reactions other than anaphylaxis; and serious local reactions. Adverse event rates in DTaP-IPV recipients were compared to historical incidence rates in the VSD population prior to 2009. Sequential probability ratio testing was used to analyze the data on a weekly basis.

Results: During the study period, 201,116 children received DTaP-IPV vaccine. Ninety-seven percent of DTaP-IPV recipients also received other vaccines on the same day, typically measles-mumps-rubella and varicella vaccines. There was no statistically significant increased risk of any of the eight pre-specified adverse events among DTaP-IPV recipients when compared to historical incidence rates.

Conclusions: In this safety surveillance study of more than 200,000 DTaP-IPV vaccine recipients, there was no evidence of increased risk for any of the pre-specified adverse events monitored. Continued surveillance of DTaP-IPV vaccine safety may be warranted to monitor for rare adverse events, such as Guillain-Barré syndrome.

Keywords: Acellular pertussis; Diphtheria; Immunization; Inactivated poliovirus combined vaccine; Surveillance; Tetanus; Vaccine; Vaccine safety.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Child
  • Child, Preschool
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage*
  • Diphtheria-Tetanus-Pertussis Vaccine / adverse effects*
  • Electronic Health Records
  • Humans
  • Poliovirus Vaccine, Inactivated / administration & dosage*
  • Poliovirus Vaccine, Inactivated / adverse effects*
  • Product Surveillance, Postmarketing*
  • Prospective Studies
  • United States
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / adverse effects

Substances

  • DTPP vaccine
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Poliovirus Vaccine, Inactivated
  • Vaccines, Combined