PEDIATRICS Vol. 102 No. 3 September 1998, pp. 546-553
Comparative Efficacy of the Lederle/Takeda Acellular Pertussis Component DTP (DTaP) Vaccine and Lederle Whole-Cell Component DTP Vaccine in German Children After Household Exposure
Received Dec 30, 1997; accepted Mar 2, 1998.
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,
From the * Klinik mit Poliklinik für Kinder und
Jugendliche der Friedrich-Alexander-Universität
Erlangen-Nürnberg, Erlangen, Germany; the Department of
Pediatrics and the UCLA Center for Vaccine Research, University of
California Los Angeles School of Medicine, Los Angeles, California;
§ Wyeth-Lederle Vaccines and Pediatrics, Pearl River, New York; the
Institut für Medizinische Statistik der
Friedrich-Alexander-Universität Erlangen-Nürnberg,
Erlangen, Germany; and the ¶ Department of Biomathematics, University
of California Los Angeles School of Medicine, Los Angeles, California.
Background. A household contact substudy was performed as part of a prospective, cohort pertussis vaccine efficacy trial in Germany.
Design. Infants received four doses of either the Lederle/Takeda acellular pertussis component diphtheria-tetanus toxoids (DTP) vaccine (DTaP) or Lederle whole-cell component DTP vaccine at 3, 4.5, 6, and 15 to 18 months of age (Wyeth-Lederle Vaccines and Pediatrics, Pearl River, NY). An open control group received three doses of diphtheria and tetanus toxoids vaccine (DT) at 3, 4.5, and 15 to 18 months of age. Vaccine efficacy rates were calculated using a number of principal and ancillary case definitions for primary, secondary, and noncases by analyzing secondary attack rates in study infants after exposure to pertussis in the household using 7- to 28- and 7- to 42-day postexposure observation periods and the inclusion and the exclusion of noncases who received macrolide antibiotics or trimethoprim-sulfamethoxazole during the exposure period.
Results. During a 3.5-year study period, 10 271 infants
(DTP or DTaP, n = 8532; DT, n = 1739)
were enrolled and actively followed along with all household members
for cough illnesses. Depending on the case definition, 160 to 519 household exposures to pertussis were identified. In general, secondary
attack rates in DT recipients were low and this was primarily because
of the frequent use of antimicrobial prophylaxis. Using the principal
case definitions and the exclusion of noncases who received macrolide
antibiotics or trimethoprim-sulfamethoxazole during the exposure
period and the 7- to 42-day observation period, the efficacy of DTP
against cough illness of 
7 days duration caused by Bordetella
pertussis was 84% (95% confidence interval [CI] = 65-93) and
that of DTaP was 58% (95% CI = 30-75). Using similar criteria,
the efficacy against typical pertussis (21 days of cough with either
paroxysms, whoop, or posttussive vomiting) was 94% (95% CI = 77-99) and 86% (95% CI = 62-95) for DTP and DTaP,
respectively. The efficacy against any cough illness (with or without)
laboratory confirmation was 54% (95% CI = 32-69) and 38% (95%
CI = 13-56) for DTP and DTaP, respectively.
Conclusion. This household contact substudy within our cohort study, with active investigator-generated surveillance, was a severe test of vaccine efficacy. Both vaccines (DTP and DTaP) are better at preventing typical pertussis than mild illness. When case definitions similar to those in other recent trials are used, the Lederle/Takeda vaccine has an efficacy similar to other multicomponent DTaP vaccines. Key words: Bordetella pertussis, acellular pertussis vaccine, whole cell pertussis vaccine, household contact, vaccine efficacy.
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