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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

Uberall, M. A. and Stehr, K. and Cherry, J. D. and Heininger, U. and Schmitt-Grohé, S. and Laussucq, S. and Eckhardt, T.. (1997) 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. Developments in biological standardization, vol. 89. pp. 83-89.

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Official URL: http://edoc.unibas.ch/dok/A5839203

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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.
Faculties and Departments:03 Faculty of Medicine > Bereich Kinder- und Jugendheilkunde (Klinik) > Kinder- und Jugendheilkunde (UKBB)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Kinder- und Jugendheilkunde (Klinik) > Kinder- und Jugendheilkunde (UKBB)
03 Faculty of Medicine
UniBasel Contributors:Heininger, Ulrich
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Note:Also published in: Pertussis vaccine trials. - Basel : Karger, 1997. - S. 83-89 -- Publication type according to Uni Basel Research Database: Journal article
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Last Modified:06 Nov 2015 10:21
Deposited On:08 Jun 2012 06:28

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