Millman Alexander J, Reynolds Sue, Duffy Jonathan, Chen Jufu, Gargiullo Paul, Fry Alicia M
Influenza Division, Centers for Disease Control and Prevention, 1600 Clifton Road MS A-32, Atlanta, GA 30329, USA; Epidemic Intelligence Service assigned to Influenza Division, Centers for Disease Control and Prevention, 1600 Clifton Road MS A-32, Atlanta, GA 30329, USA.
Influenza Division, Centers for Disease Control and Prevention, 1600 Clifton Road MS A-32, Atlanta, GA 30329, USA.
Vaccine. 2017 Jan 23;35(4):529-535. doi: 10.1016/j.vaccine.2016.12.033. Epub 2016 Dec 29.
Live attenuated influenza vaccine (LAIV) is safe in healthy children ⩾2years. The original clinical trials excluded individuals with underlying conditions; however, post-marketing data suggest LAIV may be safe for these populations.
We analyzed MarketScan Commercial Claims Databases from 2010 to 2012 to describe hospitalizations within 14days of vaccination among LAIV recipients. We evaluated LAIV recipients aged 2-18years and defined underlying conditions by presence of inpatient or outpatient ICD-9 code during the previous calendar year. We excluded asthma and immunocompromising conditions. We defined risk windows as 1-7days and 8-14days after vaccination; the control period was 12-4days prior to and 15-23days after vaccination. We conducted a self-controlled case series analysis using a conditional Poisson regression model to estimate incidence-rate ratios (IRR).
1,216,123 children aged 2-18years received LAIV from 2010 to 2012. 634 children met our inclusion criteria and were hospitalized during the observation period (12days prior to vaccination to 23days after vaccination). Of those hospitalized, 72 (11.4%) had non-asthma, non-immunocompromising underlying conditions. Children with non-asthma, non-immunocompromising underlying conditions had an all-cause hospitalization IRR of 1.1 (95% CI 0.6-2.0, p=0.83) in the 1-7day risk period and 0.9 (95% CI 0.4-1.7, p=0.67) in the 8-14day risk period. Children with no underlying conditions had an all-cause hospitalization IRR of 0.9 (0.8-1.2, p=0.60) in the 1-7day risk period and 1.1 (95% CI 0.9-1.3, p=0.53) in the 8-14day risk period. There were no differences in all-cause hospitalization risk in individuals with non-asthma, non-immunocompromising underlying conditions compared to those without underlying conditions in the 1-7day (p=0.88) or 8-14day (p=0.24) risk period.
We found no evidence of differences in post-LAIV hospitalization risk among children with non-asthma, non-immunocompromising underlying conditions compared to healthy children.
减毒活流感疫苗（LAIV）在2岁及以上健康儿童中是安全的。最初的临床试验排除了有基础疾病的个体；然而，上市后数据表明LAIV对这些人群可能是安全的。
我们分析了2010年至2012年的MarketScan商业索赔数据库，以描述LAIV接种者在接种后14天内的住院情况。我们评估了年龄在2至18岁的LAIV接种者，并根据上一个日历年的住院或门诊ICD - 9编码定义基础疾病。我们排除了哮喘和免疫功能低下的情况。我们将风险期定义为接种后1至7天和8至14天；对照期为接种前12至4天和接种后15至23天。我们使用条件泊松回归模型进行自我对照病例系列分析，以估计发病率比（IRR）。
2010年至2012年，1,216,123名2至18岁的儿童接种了LAIV。634名儿童符合我们的纳入标准，并在观察期（接种前12天至接种后23天）内住院。在这些住院儿童中，72名（11.4%）有非哮喘、非免疫功能低下的基础疾病。在1至7天的风险期内，有非哮喘、非免疫功能低下基础疾病的儿童全因住院IRR为1.1（95%CI 0.6 - 2.0，p = 0.83），在8至14天的风险期内为0.9（95%CI 0.4 - 1.7，p = 0.67）。无基础疾病的儿童在1至7天的风险期内全因住院IRR为0.9（0.8 - 1.2，p = 0.60），在8至14天的风险期内为1.1（95%CI 0.9 - 1.3，p = 0.53）。在1至7天（p = 0.88）或8至14天（p = 0.24）的风险期内，有非哮喘、非免疫功能低下基础疾病的个体与无基础疾病的个体相比，全因住院风险没有差异。
我们没有发现证据表明，与健康儿童相比，有非哮喘、非免疫功能低下基础疾病的儿童在接种LAIV后的住院风险存在差异。
