PMID- 8896531
OWN - NLM
STAT- MEDLINE
DCOM- 19961204
LR  - 20190512
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 174 Suppl 3
DP  - 1996 Nov
TI  - Acellular pertussis vaccines: the rationale for an efficacy trial in Germany.
PG  - S287-90
AB  - After concern about the safety of diphtheria-tetanus toxoid-whole cell pertussis 
      vaccines (DTPw), the recommendation to vaccinate children with DTPw was withdrawn 
      in 1974 in the former West Germany. This led pertussis cases to increase to an 
      estimated 100,000 annually. Despite renewal of the vaccination recommendation in 
      1991, vaccine use remained low. The German health care structure assures regular 
      contact between most children and pediatricians. This enabled the conduct of a 
      large efficacy trial with a diphtheria-tetanus toxoid-acellular pertussis (DTPa) 
      vaccine. Because a placebo-controlled trial was not ethically possible, a 
      prospective household contact study with a blinded clinical follow-up was done. 
      Possible study participants were screened by their pediatrician, who also 
      initiated diagnostic procedures. Clinical follow-up was done by another locally 
      based but independent and blinded physician. Vaccine efficacy was calculated to 
      be 89% (95% confidence interval, 76.6%-94.6%). None of the identified confounding 
      factors biased results in favor of the DTPa vaccine.
FAU - Schmitt, H J
AU  - Schmitt HJ
AD  - Children's Hospital, Christian-Albrechts-University zu Kiel, Germany.
FAU - Schuind, A
AU  - Schuind A
FAU - Knuf, M
AU  - Knuf M
FAU - Zepp, F
AU  - Zepp F
FAU - Beutel, K
AU  - Beutel K
FAU - Wirsing von Konig, C H
AU  - Wirsing von Konig CH
FAU - Neiss, A
AU  - Neiss A
FAU - Bock, H L
AU  - Bock HL
FAU - Bogaerts, H
AU  - Bogaerts H
FAU - Clemens, R
AU  - Clemens R
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
SB  - IM
MH  - Clinical Trials as Topic
MH  - Diphtheria-Tetanus-Pertussis Vaccine/*immunology
MH  - Germany
MH  - Humans
MH  - Research Design
MH  - Whooping Cough/*prevention & control
RF  - 20
EDAT- 1996/11/01 00:00
MHDA- 1996/11/01 00:01
CRDT- 1996/11/01 00:00
PHST- 1996/11/01 00:00 [pubmed]
PHST- 1996/11/01 00:01 [medline]
PHST- 1996/11/01 00:00 [entrez]
AID - 10.1093/infdis/174.supplement_3.s287 [doi]
PST - ppublish
SO  - J Infect Dis. 1996 Nov;174 Suppl 3:S287-90. doi: 
      10.1093/infdis/174.supplement_3.s287.