Prevention of serious events in adults 65 years of age or older: A comparison between high-dose and standard-dose inactivated influenza vaccines
Prevention of serious events in adults 65 years of age or older: A comparison between high-dose and standard-dose inactivated influenza vaccines
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DOI：
10.1016/j.vaccine.2015.07.006
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发表时间：
2015-09-11
期刊：
影响因子：
5.5
通讯作者：
Greenberg, David P.
中科院分区：
文献类型：
--
作者：
DiazGranados, Carlos A.;Robertson, Corwin A.;Greenberg, David P.
背景资料：最近的一项研究表明，在≥ 65岁的成人中，高剂量灭活流感疫苗（IIV-HD）预防实验室确认的症状性流感的有效性比标准剂量灭活流感疫苗（IIV-SD）高24.2%。在这里，我们评估的有效性IIV-HD相比IIV-SD在预防严重疾病被认为是潜在的后遗症或并发症的流感infection.Methods：原来的研究是一个双盲，随机，活性对照，多中心试验。参与者是>= 65岁的成年人，随机接受IIV-HD或IIV-SD，并在疫苗接种后随访6-8个月，以了解流感和严重不良事件（SAE）的发生情况。SAE为以下事件：导致死亡或住院（或延长住院时间）;被认为危及生命或具有医学重要性;或导致残疾。对于本分析，报告的SAE由三名设盲医生分类为可能与流感相关，并计算每1000名参与者季节的发生率。相对疫苗有效性（rVE）估计为（1率比）× 100。结果：31，989例受试者入组，其中15，991例和15，998例分别随机接受IIV-HD和IIV-SD。IIV-HD在预防总体可能与流感相关的SAE方面显著优于IN-SD（rVE，17.7%; 95%置信区间[CI]，6.6-27.4%）和严重肺炎（rVE，39.8%; 95%CI，19.3 -55.14观察到IIV-HD相对于IIV-SD预防全因住院的疗效具有边界显著性（rVE，占6.9%;结论：与IIV-SD相比，IIV-HD降低了可能与流感相关的SAE的风险。考虑到老年人流感和肺炎的负担，观察到的针对严重肺炎的相对有效性尤其值得注意。(C)2015年，作者。爱思唯尔有限公司出版
Background: A recent study showed that a high-dose inactivated influenza vaccine (IIV-HD) was 24.2% more efficacious than a standard-dose inactivated influenza vaccine (IIV-SD) in preventing laboratory-confirmed symptomatic influenza in adults >= 65 years. Here we evaluate the effectiveness of IIV-HD compared to IIV-SD in preventing serious illnesses considered potential sequelae or complications of influenza infection.Methods: The original study was a double-blind, randomized, active-controlled, multicenter trial. Participants were adults >= 65 years randomized to receive IIV-HD or IIV-SD, and followed for 6-8 months post-vaccination for the occurrence of influenza and serious adverse events (SAEs). SAEs were events: leading to death or hospitalization (or its prolongation); considered life-threatening or medically important; or resulting in disability. For the present analysis, reported SAEs were classified as possibly related to influenza by three blinded physicians and rates per 1000 participant-seasons were calculated. Relative vaccine effectiveness (rVE) was estimated as (1 - Rate Ratio) x 100.Results: 31,989 participants were enrolled, with 15,991 and 15,998 randomized to receive IIV-HD and IIV-SD, respectively. IIV-HD was significantly more effective than IN-SD in preventing SAEs possibly related to influenza overall (rVE, 17.7%; 95% confidence interval [CI], 6.6-27.4%) and serious pneumonia (rVE, 39.8%; 95% CI, 19,3-55.14 Borderline significance was observed for the efficacy of IIV-HD relative to IIV-SD for the prevention of all-cause hospitalizations (rVE, 6.9%; 95% CI, 0.5-12.8%).Conclusions: Compared to IIV-SD, IIV-HD reduced the risk of SAEs possibly related to influenza. The observed relative effectiveness against serious pneumonia is particularly noteworthy considering the burden of influenza and pneumonia in older adults. (C) 2015 The Authors. Published by Elsevier Ltd.