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August 1990

Protective Efficacy of the Takeda Acellular Pertussis Vaccine Combined With Diphtheria and Tetanus Toxoids Following Household Exposure of Japanese Children

Author Affiliations

From the Departments of Epidemiology and Biostatistics and Pediatrics, Case Western Reserve University, Cleveland, Ohio (Dr Mortimer); the Department of Pediatrics, Tokai University, Isehara, Japan (Drs Kimura and Kuno-Sakai); the Department of Pediatrics, UCLA (Dr Cherry); Lederle Laboratories, Pearl River, NY (Drs Stout, Dekker, and Scott, and Ms Hayashi); Takeda Chemical Industries Ltd, Osaka, Japan (Mr Miyamoto); the Department of Pediatrics, Keio University, Tokyo, Japan (Drs Aoyama and Iwata); the Department of Pediatrics, Nagoya (Japan) University (Dr Isomura); the Department of Pediatrics, Mie University, Tsu, Japan (Dr Kamiya); the Department of Pediatrics, St Marianna University, Tokyo (Dr Kato); Tama Children's Clinic, Kawasaki City, Japan (Dr Noya); Ube, Yamaguchi Prefecture, Japan (Dr Suzuki); the Department of Pediatrics, Kawasaki (Japan) Municipal Hospital (Dr Takeuchi); and the Yamaoka Clinic, Okayama, Japan (Dr Yamaoka).
The authors have informed us of the following information concerning their activities. Although Drs Mortimer and Cherry have no financial interest in Lederle Laboratories, they have testified as compensated expert witnesses for physicians and pharmaceutical firms in trials for alleged pertussis vaccine side effects. They also have served as paid consultants to Lederle Laboratories for the acellular pertussis vaccine project. Those authors identified with Lederle Laboratories are obviously compensated by that firm. One author holds a managerial position with Takeda Chemical Industries.

Am J Dis Child. 1990;144(8):899-904. doi:10.1001/archpedi.1990.02150320063029

• The clinical efficacy of an acellular pertussis vaccine containing lymphocytosis-promoting factor, filamentous hemagglutinin, agglutinogens, and the 69-kd outer membrane protein, combined with diphtheria and tetanus toxoids and adsorbed onto an aluminum salt, was assessed in a household contact study. The occurrence of pertussis 7 to 30 days following home exposure among 62 previously vaccinated children was compared with that among 62 unvaccinated children similarly exposed. Classic whooping cough was diagnosed in 43 unimmunized children, and 1 vaccinated child experienced a 5-week illness that was probably pertussis (efficacy, 98%; 95% confidence interval, 84% to 99%). A few children in each group incurred respiratory illnesses that may have represented mild, atypical pertussis; including these as probable pertussis, vaccine efficacy was 81% (95% confidence interval, 64% to 90%). It is concluded that prior immunization with this four-component pertussis vaccine combined with diphtheria and tetanus toxoids is highly efficacious in preventing pertussis.

(AJDC. 1990;144:899-904)