Kentucky Pediatric and Adult Research, Bardstown, KY, USA.
Pediatr Infect Dis J. 2011 Mar;30(3):203-7. doi: 10.1097/INF.0b013e3181faac7c.
Acute otitis media (AOM) is a frequent complication of influenza in young children. Influenza vaccination is known to protect against AOM by preventing influenza illness. We sought to determine the efficacy of the live attenuated influenza vaccine (LAIV) against influenza-associated AOM compared with placebo and trivalent inactivated influenza vaccine (TIV). LAIV is approved for eligible children aged ≥ 2 years in the United States and in several other countries.
AOM incidence data from 6 randomized, double-blind, placebo-controlled trials and 2 randomized, double-blind, TIV-controlled trials in children 6 to 83 months of age were pooled and analyzed.
A total of 290 cases of AOM were identified in 24,046 study subjects. LAIV efficacy against influenza-associated AOM was 85.0% (95% confidence interval [CI], 78.3%-89.8%) compared with placebo and 54.0% (95% CI, 27.0%-71.7%) compared with TIV. Efficacy trended higher in those ≥ 24 months of age compared with those aged 6 to 23 months. In placebo-controlled trials, among children who acquired influenza despite vaccination, AOM was diagnosed in 10.3% of LAIV recipients and 16.8% of placebo recipients, representing a 38.2% (95% CI, 11.0%-58.2%) relative reduction in the development of AOM. In TIV-controlled studies, among subjects with breakthrough influenza illness, the proportions of LAIV and TIV recipients who developed AOM were similar.
Children receiving LAIV had a high level of protection against influenza-associated AOM when compared with placebo or TIV. This was most evident in children older than 2 years, for whom LAIV is indicated. LAIV recipients who contracted breakthrough influenza illness despite vaccination developed AOM at a significantly lower rate than did unvaccinated children who developed influenza.
急性中耳炎（AOM）是幼儿流感的常见并发症。流感疫苗通过预防流感疾病来保护免受 AOM 的侵害。我们旨在确定与安慰剂和三价灭活流感疫苗（TIV）相比，减毒活流感疫苗（LAIV）对流感相关 AOM 的疗效。LAIV 已获批准在美国和其他几个国家用于符合条件的 2 岁及以上儿童。
汇总并分析了 6 项随机、双盲、安慰剂对照试验和 2 项随机、双盲、TIV 对照试验中 6 至 83 个月龄儿童的 AOM 发病数据。
在 24046 名研究对象中，共发现 290 例 AOM 病例。与安慰剂相比，LAIV 预防流感相关 AOM 的效力为 85.0%（95%置信区间[CI]，78.3%-89.8%），与 TIV 相比为 54.0%（95%CI，27.0%-71.7%）。在 24 个月及以上年龄的人群中，疗效趋势更高。在安慰剂对照试验中，尽管接种了疫苗，但仍发生流感的儿童中，LAIV 组和安慰剂组的 AOM 诊断率分别为 10.3%和 16.8%，表明 AOM 的发展相对减少了 38.2%（95%CI，11.0%-58.2%）。在 TIV 对照研究中，突破性流感疾病患者中，LAIV 和 TIV 组的 AOM 发生率相似。
与安慰剂或 TIV 相比，接受 LAIV 的儿童对流感相关 AOM 的保护水平较高。对于 2 岁以上的儿童，LAIV 的作用最为明显，因为这些儿童符合 LAIV 的接种条件。尽管接种了疫苗，但仍发生突破性流感的 LAIV 接种者发生 AOM 的比率明显低于未接种疫苗且发生流感的儿童。
