Clinical experience of a tricomponent acellular pertussis vaccine combined with diphtheria and tetanus toxoids for primary vaccination in 22,505 infants

被引:65
作者
Schmitt, HJ
Schuind, A
Knuf, M
Beutel, K
SchulteWissermann, H
Gahr, M
Schult, R
Folkens, J
Rauh, W
Bogaerts, H
Bork, HL
Clemens, R
机构
[1] UNIV MAINZ, CHILDRENS HOSP, D-6500 MAINZ, GERMANY
[2] MUNICIPAL HOSP, KREFELD, GERMANY
[3] UNIV GOTTINGEN, CHILDRENS HOSP, D-3400 GOTTINGEN, GERMANY
[4] CHILDRENS HOSP, OFFENBURG, GERMANY
[5] PEDIAT AMBULANCE FLENSBURG, FLENSBURG, GERMANY
[6] CHILDRENS HOSP, MUTTERHAUS BORROMAERINNEN, TRIER, GERMANY
[7] SMITHKLINE BEECHAM BIOL, RIXENSART, BELGIUM
关键词
D O I
10.1016/S0022-3476(96)70152-X
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
Objectives: To assess the safety and tolerability of 12 lots of SmithKline Beecham Biologicals' diphtheria-tetanus-tricomponent acellular pertussis vaccine (DTaP) in a large cohort of 22,000 vaccinees, with detailed analyses of reactivity, immunogenicity, and immune response to pertussis toxin in subsets. Methods: In a prospective, double-blind, multicenter trial in Germany, 22,505 healthy infants received three vaccinations of DTaP at age 3, 4, and 5 months. Serious adverse events were followed for 1 month after each vaccination, and neurologic events for 1 year or longer, Serum IgG antibodies were assayed before vaccination and 1 month after vaccination. Results: After 67,000 doses, 153 serious adverse events (0.23%) were reported, 8 considered possibly related, and 5 related to vaccination, including 1 hypotonic-hyporesponsive episode, Incidence rates of sudden infant death syndrome (7; 0.01%) or acute neurologic events (20; 0.030%) were no higher than expected and not considered to be related to vaccination, Redness and swelling of 20 mm or greater occurred after 44 (0.6%) and 40 (0.6%) of the 7270 doses, respectively, and high fever (>39,5 degrees C) in 6 (0.08%) subjects within 48 hours of vaccination. in the immunogenicity analysis of 580 infants, 98% responded to pertussis toxin, 96% to filamentous hemagglutinin, and 98% to pertactin, In an additional 5712 infants, the response rate to pertussis toxin was 99%. Conclusions: In a large cohort of 22,505 infants vaccinated, SmithKline Beecham Biologicals' tricomponent DTaP vaccine was shown to be safe, well-tolerated, and immunogenic for all component antigens.
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收藏
页码:695 / 701
页数:7
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