title: Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers.
abstract: The combination DTaP-IPV/Hib vaccine was licensed in the United States in 2008 for children ages 6weeks through 4years with doses administered at 2, 4, 6, and 15-18months of age. The aim of this study was to assess the safety of DTaP-IPV/Hib vaccine routinely administered as part of clinical care to infants at Kaiser Permanente Northern California.
  
  
  
  This was an observational, retrospective study that included all 2-month-old infants vaccinated with either DTaP-IPV/Hib or another DTaP-containing vaccine. We monitored all subjects for non-elective hospitalizations, emergency department visits and selected outpatient outcomes (seizures, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness, meningitis, hypersensitivity reactions, immune thrombocytopenic purpura, hemolytic anemia, type 1 diabetes, and Kawasaki disease) beginning with their first dose through 6months after a 4th dose or until 24months of age. We calculated incidence rate ratios (IRRs) in the primary analysis by comparing rates of outcomes during the post-vaccination risk interval with rates during a comparison interval more remote from vaccination. Secondary analyses compared outcomes after DTaP-IPV/Hib with those after other DTaP-containing vaccines. We reviewed the medical records of selected outcomes.
  
  
  
  From October 1, 2008 through July 31, 2010, 14,042 subjects received a first dose of DTaP-IPV/Hib, 13,194 received 2 doses, 12,548 received 3 doses and 6702 received 4 doses. Overall, there were 166 comparisons with significantly elevated IRRs and 165 comparisons with significantly reduced IRRs. Medical record review of outcomes with significantly elevated IRRs in both the primary and secondary analyses did not suggest any relationship with DTaP-IPV/Hib.
  
  
  
  This study did not detect any safety concerns following DTaP-IPV/Hib and provides reassurance that DTaP-IPV/Hib administered as part of routine care was not associated with unexpected safety risks. ClinicalTrials.gov Identifier: NCT00804284.
authors.affiliation: Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA. Electronic address: john.hansen@kp.org.
authors.forename: John
authors.initials: J
authors.lastname: Hansen
authors.affiliation: Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA.
authors.forename: Julius
authors.initials: J
authors.lastname: Timbol
authors.affiliation: Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA.
authors.forename: Ned
authors.initials: N
authors.lastname: Lewis
authors.affiliation: Scientific and Medical Affairs, Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA.
authors.forename: Vitali
authors.initials: V
authors.lastname: Pool
authors.affiliation: Scientific and Medical Affairs, Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA; Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN 37212, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Decker
authors.affiliation: Scientific and Medical Affairs, Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA.
authors.forename: David P
authors.initials: DP
authors.lastname: Greenberg
authors.affiliation: Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza 16B, Oakland, CA 94612, USA.
authors.forename: Nicola P
authors.initials: NP
authors.lastname: Klein
mesh_terms: D002140:California; D002675:Child, Preschool; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D018570:Risk Assessment; D014611:Vaccination / Q000009:adverse effects*; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D011054:Poliovirus Vaccine, Inactivated; D018074:Vaccines, Conjugate; C541234:diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine
keywords: DTaP-IPV/Hib; Safety; Vaccine