Black S B, Shinefield H R
Kaiser Permanente Medical Center, Oakland, CA 94611.
Pediatr Infect Dis J. 1992 Aug;11(8):610-3.
Between February, 1988, and June, 1990, the safety, immunogenicity and efficacy of the HbOC (oligosaccharide conjugate Haemophilus influenza type b) vaccine was evaluated in a prelicensure trial performed in a study population of 61,080 children within the Northern California Kaiser Permanente Medical Care Program. In this evaluation the HbOC vaccine was found to be safe, immunogenic and efficacious in infancy. Since licensure an estimated 162,000 additional doses of HbOC vaccine have been given to 75,000 additional children. In addition to reporting on extended follow-up of this population, this publication reports on the impact of immunizing a high proportion of the Northern California Kaiser Permanente Medical Care Program population in infancy and early childhood on the epidemiology of invasive disease caused by H. influenzae type b (Hib) and invasive disease caused by non-type b H. influenzae. As of January 31, 1992, six cases of Hib invasive disease have been identified in vaccinated children. Of these five occurred in children who had received only one dose of vaccine in infancy. One case of Hib meningitis occurred in a 3 1/2-year-old child who had received doses of HbOC at 2, 4 and 6 months of age but no further doses of any Hib vaccines. During 1991 a total of three cases of invasive disease caused by Hib were observed in children younger than 18 months of age within the Northern California Kaiser Permanente Medical Care Program. This represents a 94% reduction in disease incidence in this age group from that observed in the years 1984 to 1987.(ABSTRACT TRUNCATED AT 250 WORDS)
1988年2月至1990年6月期间,在北加利福尼亚凯撒医疗保健计划中的61080名儿童研究人群中进行了HbOC(b型流感嗜血杆菌寡糖结合疫苗)疫苗的上市前试验,评估了其安全性、免疫原性和有效性。在该评估中,发现HbOC疫苗在婴儿期是安全、具有免疫原性且有效的。自获得许可以来,估计又有162000剂HbOC疫苗接种给了另外75000名儿童。除了报告该人群的长期随访情况外,本出版物还报告了在婴儿期和幼儿期对北加利福尼亚凯撒医疗保健计划中高比例人群进行免疫接种对b型流感嗜血杆菌(Hib)引起的侵袭性疾病和非b型流感嗜血杆菌引起的侵袭性疾病流行病学的影响。截至1992年1月31日,在接种疫苗的儿童中已发现6例Hib侵袭性疾病。其中5例发生在婴儿期仅接种了一剂疫苗的儿童中。1例Hib脑膜炎发生在一名3岁半的儿童身上,该儿童在2、4和6个月大时接种了HbOC疫苗,但未再接种任何Hib疫苗。1991年,在北加利福尼亚凯撒医疗保健计划中,18个月以下的儿童中共观察到3例由Hib引起的侵袭性疾病。这表明该年龄组的疾病发病率比1984年至1987年观察到的发病率降低了94%。(摘要截短至250字)