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A Comparative Trial of the Reactogenicity and Immunogenicity of Takeda Acellular Pertussis Vaccine Combined With Tetanus and Diphtheria ToxoidsOutcome in 3- to 8-Month-Old Infants, 9- to 23-Month-Old Infants and Children, and 24- to 30-Month-Old Children
Mikio Kimura, MD;
Harumi Kuno-Sakai, MD;
Yuji Sato, PhD;
Hitoshi Kamiya, MD;
Ritsue Nii, MD;
Shin Isomura, MD;
Kiyoshi Horiuchi, MD;
Tatsuo Kato, MD;
Masanori Deguchi, MD;
Hiroaki Saikusa, MD;
Edward A. Mortimer, Jr, MD;
James D. Cherry, MD
Am J Dis Child. 1991;145(7):729-733.
Abstract
The reactogenicity and immunogenicity of the Takeda acellular pertussis vaccine combined with tetanus and diphtheria toxoids were compared in 139 infants aged 3 to 8 months, 60 infants and children aged 9 to 23 months, and 99 children aged 24 to 30 months. Good antibody responses to pertussis toxin (PT), filamentous hemagglutinin (FHA), and agglutinogens occurred in all age groups after both the third and fourth doses. After the fourth (booster) dose, the mean antibody values in initially seronegative infants vaccinated at 3 to 8 months of age were as follows: anti-PT, 67.8 enzyme-linked immunosorbent assay units (EU) per milliliter; anti-FHA, 149.5 EU/mL; the agglutinin titer was 125.6. The values in initially seronegative children vaccinated at 24 to 30 months of age were as follows: anti-PT, 92.9 EU/mL; anti-FHA, 251.7 EU/mL; the agglutinin titer was 275.8. Reactions following immunization were minimal. Except for drowsiness after the first dose in infants, there were no clinically significant differences in reactions between infants and older children. The findings in this study coupled with the recent demonstration of efficacy of this vaccine in 2-year-old children supports the recent Japanese recommendation to lower the age of immunization with acellular pertussis vaccine combined with tetanus and diphtheria toxoids to 3 months.
(AJDC. 1991;145:734-741)
Author Affiliations
From the Department of Pediatrics, Tokai University School of Medicine, Isehara; Japan (Drs Kimura and Kuno-Sakai), the Department of Pediatrics, Mie National Hospital, Tsu, Japan (Drs Kamiya and Nii), Aichi Prefectural Institute of Public Health, Nagoya, Japan (Dr Isomura), Department of Pediatrics, National Higashi-Tochigi Hospital, Utsunomiya, Japan (Dr Horiuchi), Deguchi Pediatrics Clinic, Omura, Japan (Dr Deguchi), and Saikusa Pediatrics Clinic, Sasebo, Japan (Dr Saikusa), Department of Bacteriology, National Institutes of Health, Tokyo, Japan (Dr Sato); Department of Pediatrics, St Marianna University, Kawasaki, Japan (Dr Kato); Department of Epidemiology and Biostatistics, Case Western Reserve University School of Medicine, Cleveland, Ohio (Dr Mortimer); and Department of Pediatrics, UCLA School of Medicine (Dr Cherry).
Footnotes
Accepted for publication November 12, 1990.
Reprint requests to Tokai University School of Medicine, Department of Pediatrics, Isehara, Kanagawa, Japan (Dr Kimura).
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