评估儿童接种减毒活疫苗与灭活流感疫苗后的发热频率。
Assessing Fever Frequency After Pediatric Live Attenuated Versus Inactivated Influenza Vaccination.
机构信息
Department of Pediatrics.
Department of Population and Family Health, Mailman School of Public Health, Columbia University.
出版信息
J Pediatric Infect Dis Soc. 2017 Sep 1;6(3):e7-e14. doi: 10.1093/jpids/piw028.
BACKGROUND
Some studies have found a higher frequency of fever with trivalent live attenuated influenza vaccine (LAIV) than with inactivated influenza vaccine (IIV), but quadrivalent LAIV has not been assessed. Understanding fever is important for safety reviews and for parents and providers. In addition, there have been only a limited number of studies in which text messaging was used for vaccine adverse-event (AE) surveillance.
METHODS
We conducted a prospective observational study in 3 community clinics in New York City to assess post-influenza vaccination fever in 24- to 59-month-olds during the 2013-2014 season. Enrolled families of children who received quadrivalent LAIV (LAIV4) or IIV (trivalent IIV3 or quadrivalent IIV4) replied to text messages that assessed their temperature on vaccination night and the next 10 nights (days 0 to 10); missing data were collected via telephone and a diary. We compared frequencies of fever (temperature ≥ 100.4°F) according to vaccine group on days 0 to 2 and 3 to 10 by using χ2 and multivariate log-binomial regression adjusted for age, previous influenza vaccination, and vaccine coadministration. We also assessed outcomes using all sources versus only text messages.
RESULTS
Most (84.1% [n = 540]) eligible parents enrolled. Fever frequencies on days 0 to 2 did not differ between LAIV4 and any IIV (3.8% vs 5.7%, respectively; adjusted relative risk [aRR] [95% confidence interval], 0.60 [0.25-1.46]), between LAIV4 and IIV4 (4.2% vs 7.1%, respectively; aRR, 0.58 [0.19-1.72]), or between IIV4 and IIV3 (7.1% vs 6.0%, respectively; aRR, 1.02 [0.30-3.46]). The findings were similar when all data sources versus text-message data alone were used. There were no significant differences on days 3 to 10.
CONCLUSIONS
Postvaccination fever frequencies were low overall and did not differ according to influenza vaccine type during the 2013-2014 influenza season. The similarity of results when data were limited to text messages lends support to its use for surveillance of vaccine adverse events.
背景
一些研究发现，三价减毒活流感疫苗（LAIV）引起发热的频率高于灭活流感疫苗（IIV），但尚未评估四价 LAIV。了解发热对于安全性评估以及对于父母和提供者都很重要。此外，使用短信进行疫苗不良反应（AE）监测的研究数量有限。
方法
我们在纽约市的 3 个社区诊所进行了一项前瞻性观察研究，以评估 2013-2014 流感季节 24 至 59 月龄儿童接种四价 LAIV（LAIV4）或 IIV（三价 IIV3 或四价 IIV4）后的发热情况。接种疫苗当晚及接下来的 10 晚（第 0 至 10 天），入组儿童的家庭通过短信回复体温情况；若漏报，则通过电话和日记收集数据。我们使用 χ2 和多元对数二项式回归（按年龄、既往流感疫苗接种情况和疫苗联合使用情况进行调整）比较疫苗组第 0 至 2 天和第 3 至 10 天的发热（体温≥100.4°F）频率。我们还使用所有来源和仅短信数据评估了结果。
结果
大多数（84.1%[n=540]）符合条件的父母入组。LAIV4 和任何 IIV 的第 0 至 2 天发热频率无差异（分别为 3.8%和 5.7%；调整后的相对风险[95%置信区间]，0.60[0.25-1.46]），LAIV4 和 IIV4 之间（分别为 4.2%和 7.1%；0.58[0.19-1.72]），或 IIV4 和 IIV3 之间（分别为 7.1%和 6.0%；1.02[0.30-3.46]）。当使用所有数据来源与仅短信数据时，结果相似。第 3 至 10 天无显著差异。
结论
2013-2014 流感季节，接种疫苗后发热频率总体较低，且与流感疫苗类型无关。当数据仅限于短信时，结果相似，这支持了其用于疫苗不良反应监测。
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