Schmitt H J, Schuind A, Knuf M, Beutel K, Schulte-Wissermann H, Gahr M, Schult R, Folkens J, Rauh W, Bogaerts H, Bork H L, Clemens R
Children's Hospital, Johannes Gutenberg University, Mainz, Germany.
J Pediatr. 1996 Nov;129(5):695-701. doi: 10.1016/s0022-3476(96)70152-x.
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.
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.
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%.
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.
在22000名疫苗接种者的大型队列中评估史克必成生物制品公司生产的12批次白喉-破伤风-三联无细胞百日咳疫苗（DTaP）的安全性和耐受性，并对亚组中的反应性、免疫原性及对百日咳毒素的免疫反应进行详细分析。
在德国进行的一项前瞻性、双盲、多中心试验中，22505名健康婴儿在3、4、5月龄时各接种3剂DTaP。每次接种后随访1个月的严重不良事件，随访1年或更长时间的神经系统事件。在接种前及接种后1个月检测血清IgG抗体。
在接种67000剂后，报告了153例严重不良事件（0.23%），其中8例被认为可能相关，5例与疫苗接种有关，包括1例低张力-低反应发作。婴儿猝死综合征（7例；0.01%）或急性神经系统事件（20例；0.030%）的发生率不高于预期，且不认为与疫苗接种有关。在7270剂疫苗接种后，分别有44例（0.6%）和40例（0.6%）出现20mm或更大范围的红肿，6例（0.08%）受试者在接种后48小时内出现高热（>39.5℃）。在对580名婴儿的免疫原性分析中，98%的婴儿对百日咳毒素有反应，96%对丝状血凝素反应，98%对百日咳杆菌粘附素反应。在另外5712名婴儿中，对百日咳毒素的反应率为99%。
在22505名接种疫苗的婴儿大型队列中，史克必成生物制品公司的三联DTaP疫苗对所有组分抗原显示出安全、耐受性良好且具有免疫原性。
