EFFICACY IN INFANCY OF OLIGOSACCHARIDE CONJUGATE HAEMOPHILUS-INFLUENZAE TYPE-B (HBOC) VACCINE IN A UNITED-STATES POPULATION OF 61080 CHILDREN
EFFICACY IN INFANCY OF OLIGOSACCHARIDE CONJUGATE HAEMOPHILUS-INFLUENZAE TYPE-B (HBOC) VACCINE IN A UNITED-STATES POPULATION OF 61080 CHILDREN
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DOI：
10.1097/00006454-199102000-00004
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发表时间：
1991-02-01
影响因子：
3.6
通讯作者：
VITTINGHOFF, E
中科院分区：
文献类型：
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作者：
BLACK, SB;SHINEFIELD, HR;VITTINGHOFF, E
在北加州Kaiser Permanente医疗保健计划的61080名婴儿研究人群中，对HBOC结合b型流感嗜血杆菌疫苗的有效性进行了评估。1988年2月至1990年6月，在2个月、4个月和6个月大的婴儿中，作为三剂系列疫苗的一部分，为20800名婴儿接种了HBOC疫苗。研究人群包括在生命最初6个月期间在研究中心接受过良好护理访问的儿童。在研究人群中有25例b型流感嗜血杆菌病例：22例未接种疫苗，3例仅接种一剂HBOC疫苗。通过几种方法评估了完整的三剂系列疫苗的有效性：比较7至18个月大的完全接种疫苗的儿童和未接种疫苗的儿童的初步分析；根据年龄和季节性调整的分层准确分析；以及进一步调整已知危险因素的病例对照分析。三剂疫苗的有效率为100%，三次分析的95%可信区间下限分别为68%、71%和%。没有两剂HBOC疫苗对两剂HBOC疫苗产生100%疗效的估计(95%可信区间，47到100)的疾病病例。然而，对于只接种一剂HBOC疫苗的儿童，疫苗效力估计为26%，不能排除一剂HBOC疫苗无效的可能性。意向治疗分析和对可能的偏见来源的补充分析支持这样的结论，即接种HBOC疫苗在婴儿时期预防B型流感嗜血杆菌疾病是有效的。
The efficacy of the HbOC conjugate Haemophilus influenzae type b vaccine was evaluated in a study population of 61 080 infants in the Northern California Kaiser Permanente Medical Care Program. Between February, 1988, and June, 1990, the HbOC vaccine was given as part of a three-dose series at 2, 4 and 6 months of age to 20 800 infants. The study population included children with a well-care visit at a study center during the first 6 months of life. There were 25 cases of Haemophilus influenzae type b disease in the study population: 22 in unvaccinated children and 3 in children who received only one dose of HbOC vaccine. The efficacy of the full three-dose series was evaluated by several methods: a primary analysis comparing fully vaccinated children with unvaccinated children from 7 to 18 months of age; a stratified exact analysis adjusted for age and seasonality; and a case-control analysis which further adjusted for known risk factors. The efficacy of three doses of vaccine was 100% with the lower bound of the 95% confidence interval for the three analyses at 68, 71, and 64%, respectively. There were no cases of disease resulting from two doses of HbOC vaccine yielding an estimate of 100% efficacy (95% confidence interval, 47 to 100) for two doses of HbOC vaccine. However, for children who had received only one dose of HbOC vaccine, vaccine efficacy was estimated to be 26% and the possibility that one dose of HbOC vaccine had no efficacy could not be excluded. An intent-to-treat analysis and supplementary analyses of possible sources of bias supported the conclusion that immunization with HbOC vaccine was effective in preventing H. influenzae type b disease in infancy.