Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA.
Vaccine. 2012 Apr 19;30(19):2989-98. doi: 10.1016/j.vaccine.2012.02.039. Epub 2012 Feb 29.
Live attenuated influenza vaccine (LAIV) was licensed in 2003 in the United States for use in individuals aged 5-49 years.
A prospective observational postmarketing study was conducted to evaluate the safety of LAIV. Rates of medically attended events (MAEs) and serious adverse events (SAEs) in eligible children aged 5-17 years receiving LAIV as part of routine care from October 2003 to March 2008 were compared with rates in nonrandomized self, matched unvaccinated, and matched trivalent inactivated influenza vaccine (TIV)-vaccinated controls. All MAEs and SAEs through 42 days postvaccination and all hospitalizations and deaths through 6 months postvaccination were analyzed. Statistical significance was assigned without multiplicity adjustment.
43,702 LAIV recipients were matched with similar numbers of TIV-vaccinated and unvaccinated children. Of approximately 9500 MAE incidence rate comparisons, 204 were statistically significantly higher and 168 were statistically significantly lower in LAIV recipients versus controls. No pattern of MAE rate differences suggested a safety signal with LAIV. Asthma/wheezing MAEs were not statistically increased in LAIV recipients. No anaphylaxis events occurred within 3 days postvaccination. Rates of SAEs were similar between LAIV and control groups. Two SAEs were considered possibly related to LAIV: Bell's palsy and nonspecific paroxysmal spell.
Results of this postlicensure evaluation of LAIV safety in US children aged 5-17 years are consistent with preapproval clinical studies and Vaccine Adverse Event Reporting System reports, both of which demonstrated no significant increase in asthma/wheezing events or other adverse outcomes among eligible children who received LAIV.
活减毒流感疫苗（LAIV）于 2003 年在美国获得许可，用于 5-49 岁人群。
进行了一项前瞻性观察性上市后研究，以评估 LAIV 的安全性。2003 年 10 月至 2008 年 3 月，在常规护理中为 5-17 岁符合条件的儿童接种 LAIV 作为部分接种人群，与未随机、自我匹配、未接种疫苗和匹配三价灭活流感疫苗（TIV）的对照组相比，评估其出现医疗相关不良事件（MAE）和严重不良事件（SAE）的发生率。分析了接种后 42 天内所有 MAE 和 SAE，以及接种后 6 个月内所有住院和死亡情况。未进行多重调整即确定了统计学意义。
43702 名 LAIV 接种者与数量相似的 TIV 接种者和未接种者进行了匹配。在大约 9500 次 MAE 发生率比较中，LAIV 接种者与对照组相比，204 次 MAE 发生率显著更高，168 次 MAE 发生率显著更低。LAIV 并未显示出安全性信号。LAIV 接种者的哮喘/喘息 MAE 发生率未增加。接种后 3 天内未发生过敏反应事件。LAIV 组和对照组的 SAE 发生率相似。有 2 例 SAE 被认为可能与 LAIV 相关：贝尔麻痹和非特异性阵发性发作。
该研究对美国 5-17 岁儿童 LAIV 安全性的上市后评估结果与预批准的临床研究和疫苗不良反应报告系统报告一致，均显示合格儿童接种 LAIV 后，哮喘/喘息事件或其他不良结局无显著增加。
