Safety, efficacy, and effectiveness of live, attenuated, cold-adapted influenza vaccine in an indicated population aged 5-49 years
Safety, efficacy, and effectiveness of live, attenuated, cold-adapted influenza vaccine in an indicated population aged 5-49 years
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DOI：
10.1086/423001
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发表时间：
2004-10-01
影响因子：
11.8
通讯作者：
Mendelman, PM
中科院分区：
文献类型：
--
作者：
Belshe, RB;Nichol, KL;Mendelman, PM
背景资料。三项重要的研究支持了流感减毒活疫苗的许可：(1)一项涉及15-71个月大的儿童的儿科疗效试验；(2)一项关于1-17岁儿童中发生的医疗事件的大型安全性研究；(3)一项涉及18-年龄段的健康工作成人的有效性试验。在美国食品和药物管理局(FDA)对CAIV-T用于健康人的批准进行审查期间，通过使用原始方案未预先指定的各种年龄组，进行了额外的亚组分析，以评估疫苗的安全性、有效性和有效性。CAIV-T目前被FDA批准用于5-49岁的健康人。在这篇文章中，我们提供了来自前述一些子分析的数据。CAIV-T在大于或等于5岁的儿童中的疗效(研究第一年儿童的年龄范围为60-71个月；研究第二年儿童的年龄范围为60-83个月)与第一年报告的整个队列的疗效相似(90.6%；95%可信区间[CI]，70.3%-97.1%)。在研究的第二年，尽管存在抗原漂移的甲型/悉尼/5/97型流感(H3N2)，但有效率为86.9%(95%可信区间，70.8%-94.1%)，这种流感导致了第二年发生的大多数疾病。5-17岁儿童的安全性结果显示，在急性呼吸道事件、急性胃肠道事件、全身细菌感染或可能与流感有关的罕见事件方面，疫苗接受者和安慰剂接受者之间没有显著差异。在18-49岁的成年人中的疗效与整个队列中报道的相似--例如，对于严重发烧疾病的发生，成年人减少了19.5%(P=0.02)。本重新分析汇总了5-49岁人群中CAIV-T的指示用途的数据。
Background. Three important studies have supported licensure of live, attenuated, cold- adapted influenza vaccine ( CAIV- T [ FluMist; MedImmune Vaccines]): ( 1) a pediatric efficacy trial involving children 15 - 71 months of age, ( 2) a large safety study of medically attended events occurring among children 1 - 17 years of age, and ( 3) an effectiveness trial involving healthy working adults 18 - 64 years of age.Methods. During the United States Food and Drug Administration ( FDA) review for the approval of CAIV-T for use in healthy persons, additional subgroup analyses were conducted to evaluate the safety, efficacy, and effectiveness of the vaccine, by use of various age subsets not prespecified by the original protocols. CAIV- T is currently approved by the FDA for use in healthy persons 5 - 49 years of age. In this article, we present data from some of the aforementioned subanalyses.Results. The efficacy of CAIV- T in children greater than or equal to 5 years of age ( age range of the children in year 1 of the study, 60 - 71 months; age range of the children in year 2 of the study, 60 - 83 months) was similar to that reported for the entire cohort in year 1 ( 90.6%; 95% confidence interval [ CI], 70.3% - 97.1%). In year 2 of the study, efficacy was 86.9% ( 95% CI, 70.8% - 94.1%), despite the presence of antigenically drifted influenza type A/ Sydney/ 5/ 97 ( H3N2), which caused most illnesses that occurred in year 2. Safety outcomes for children 5 - 17 years of age revealed no significant difference between vaccine recipients and placebo recipients, with regard to acute respiratory events, acute gastrointestinal events, systemic bacterial infection, or rare events possibly related to influenza. Effectiveness among adults 18 - 49 years of age was similar to that reported for the entire cohort - for example, for occurrence of severe febrile illness, there was a 19.5% reduction (P = .02) in adults.Conclusions. The present reanalysis summarizes data on the indicated uses for CAIV- T in the indicated population aged 5 - 49 years.