title: Severe adverse events in a comparative efficacy trial in Germany in infants receiving either the Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) or DT vaccine. The Pertussis Vaccine Study Group.
abstract: Severe adverse events were evaluated in a comparative efficacy trial in Germany in infants who received either the Lederle/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) or DT vaccine. Vaccinees received four doses (at three, four-and-a half, six and 15-18 months of age) of either DTP or DTaP vaccine or three doses at three, four-and-a half and 15-18 months of age) of DT vaccine. The analysis included 4,273 DTaP recipients, 4,259 DTP recipients and 1,739 DT vaccinees. Convulsions within three days of vaccination occurred in 1/15,912 doses in DTaP recipients and 1/3,926 doses in DTP vaccinees (p = 0.22). Persistent inconsolable crying was more common in DTP vaccinees (1/113 doses) compared with DTaP (1/497 doses, p < 0.001) and DT (1/359 doses, p < 0.001) recipients. High fever (< or = 40.5 degrees C) was less frequent in DTaP vaccinees (1/16,239 doses) compared with DTP (1/5,359) and DT recipients (1/4,665). One hypotonic-hyporesponsive episode was observed.
authors.affiliation: Universitätsklinik für Kinder und Jugendliche, Erlangen, Germany.
authors.forename: M A
authors.initials: MA
authors.lastname: Uberall
authors.forename: K
authors.initials: K
authors.lastname: Stehr
authors.forename: J D
authors.initials: JD
authors.lastname: Cherry
authors.forename: U
authors.initials: U
authors.lastname: Heininger
authors.forename: S
authors.initials: S
authors.lastname: Schmitt-Grohé
authors.forename: S
authors.initials: S
authors.lastname: Laussucq
authors.forename: T
authors.initials: T
authors.lastname: Eckhardt
mesh_terms: D015331:Cohort Studies; D004168:Diphtheria Toxoid / Q000009:adverse effects*; D022422:Diphtheria-Tetanus Vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D004311:Double-Blind Method; D005858:Germany; D006801:Humans; D007223:Infant; D008137:Longitudinal Studies; D013745:Tetanus Toxoid / Q000009:adverse effects*; D016896:Treatment Outcome; D017778:Vaccines, Combined / Q000009:adverse effects; D014917:Whooping Cough / Q000517:prevention & control* / Q000628:therapy
chemical_list: D004168:Diphtheria Toxoid; D022422:Diphtheria-Tetanus Vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D013745:Tetanus Toxoid; D017778:Vaccines, Combined