Schmitt H J, Beutel K, Schuind A, Knuf M, Wagner S, Müschenborn S, Bogaerts H, Bock H L, Clemens R
Children's Hospital, University of Mainz, Germany.
J Pediatr. 1997 Apr;130(4):616-23. doi: 10.1016/s0022-3476(97)70247-6.
The primary objective was to assess the nature and incidence of adverse events after a fourth dose of a tricomponent acellular pertussis-diphtheriatetanus vaccine given in the second year of life after primary vaccination with the same vaccine at 3, 4, and 5 months of age. A secondary objective was to analyze the immunogeniecity of the booster vaccination.
Of the 5361 children enrolled (aged 14 to 28 months), adverse reactions were specifically solicited from the first 1863 enrollees for the first 4 days after vaccination and then were unsolicited for the remainder of the 4 weeks of follow-up (group 1). In the next 3498 subjects, safety and reactogenicify were entirely unsolicited for this 4-week period (group 2). Immunogenicity was analyzed by means of prebooster and postbooster serum antibody titers for all vaccine components in a random subgroup of 197 children from group 1.
Soliciting symptoms elicited reports of at least one symptom in 1314 of 1809 children in group 1 (72.6%), including 993 (54.9%) with local and 885 (48.9%) with general symptoms during the first 4 days after vaccination. When symptoms were gathered in an unsolicited fashion, only 580 of 3498 children in group 2 (16.6%) had a reported symptom during this time, consisting of 344 (9.8%) local and 319 (9.1%) general symptoms, respectively. An unsolicited symptom, areactive edematous swelling of the whole thigh, occurred in 62 children (1.1%), with 45 and 17 reports in groups 1 and 2, respectively. The vast majority of all reported symptoms were mild to moderate, and all children recovered without sequelae. Fourteen serious adverse events were reported, but none was considered to be related to the vaccination. Immunogenicity analysis showed a vaccine response to pertussis toxin in 99.5% of subjects, to filamentous hemagglutinin in 98.5%, and to pertactin (69 kd outer membrane protein) in 99%. All subjects had postvaccination antibody titers of 0.1 IU/ml or greater against diphtheria and tetanus toxoids.
主要目的是评估在3、4、5月龄时用相同的三联无细胞百日咳-白喉-破伤风疫苗进行基础免疫后，在出生后第二年接种第四剂该疫苗后不良事件的性质和发生率。次要目的是分析加强免疫的免疫原性。
在纳入的5361名儿童（14至28月龄）中，对前1863名入组儿童在接种疫苗后的前4天专门询问不良反应情况，然后在接下来4周的随访中不再专门询问（第1组）。在接下来的3498名受试者中，在这4周期间完全不再专门询问安全性和反应原性情况（第2组）。对第1组中随机抽取的197名儿童，通过加强免疫前和加强免疫后的血清抗体滴度分析所有疫苗成分的免疫原性。
在第1组的1809名儿童中，主动询问症状时，有1314名（72.6%）报告了至少一种症状，其中993名（54.9%）在接种疫苗后的前4天出现局部症状，885名（48.9%）出现全身症状。当以非主动询问的方式收集症状时，第2组的3498名儿童中只有580名（16.6%）在此期间报告了症状，分别包括344名（9.8%）局部症状和319名（9.1%）全身症状。一种非主动询问到的症状，即整个大腿的反应性水肿肿胀，在62名儿童（1.1%）中出现，第1组和第2组分别有45例和17例报告。所有报告的症状绝大多数为轻至中度，所有儿童均康复且无后遗症。报告了14例严重不良事件，但均被认为与疫苗接种无关。免疫原性分析显示，99.5%的受试者对百日咳毒素有疫苗反应，98.5%对丝状血凝素，99%对百日咳杆菌粘附素（69 kd外膜蛋白）有反应。所有受试者接种疫苗后的白喉和破伤风类毒素抗体滴度均达到0.1 IU/ml或更高。
