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.
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.
Uberall
M A
MA
Universitätsklinik für Kinder und Jugendliche, Erlangen, Germany.
Stehr
K
K
Cherry
J D
JD
Heininger
U
U
Schmitt-Grohé
S
S
Laussucq
S
S
Eckhardt
T
T
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
D004168:Diphtheria Toxoid; D022422:Diphtheria-Tetanus Vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D013745:Tetanus Toxoid; D017778:Vaccines, Combined