Randomized Controlled Trial of Dose Response to Influenza Vaccine in Children Aged 6 to 23 Months
Randomized Controlled Trial of Dose Response to Influenza Vaccine in Children Aged 6 to 23 Months
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DOI：
10.1542/peds.2010-2777
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发表时间：
2011-08-01
期刊：
影响因子：
8
通讯作者：
Petric, Martin
中科院分区：
文献类型：
--
作者：
Skowronski, Danuta M.;Hottes, Travis S.;Petric, Martin
目的：我们评估了 2 剂全剂量和 2 剂半剂量的三价灭活流感疫苗 (TIV) 是否可以在不增加婴儿（6-11 个月）和幼儿（12-23 个月）反应原性的情况下提高免疫原性。方法：之前未免疫的婴儿和幼儿被分别随机分配接受 2 剂全剂（0.5 mL）或 2 剂半剂（0.25 mL）。 2008-2009 年拆分 TIV。在入组时以及第二次注射后 27 至 45 天收集血清。父母在每次注射后记录不良事件。主要免疫原性结果是全剂量与半剂量相比的优越性（单侧，α = 0.025），基于血清保护率增加> 10％（血凝抑制滴度> = 40）。主要反应原性结果是注射后 3 天内发烧 >= 38 摄氏度。 结果：在符合方案分析中，纳入了 252 名参与者（全剂量：n = 124；半剂量：n = 128）。在幼儿中，所有 3 种疫苗成分的免疫后血清保护率均超过 85%，且剂量之间没有显着差异。在婴儿中，全剂量对所有 3 种疫苗成分均产生较高的反应，满足 H3N2 的 10% 优越性检验（75.4% vs 47.6%；Delta = 27.8% [95% 置信区间 (CI)：11.2-44.5]；P = 0.02）和 B/Yamagata（70.2% vs 41.3%；Delta = 28.9%） [95% CI: 11.9-45.9]；P = .02) 成分，但不是 H1N1（71.9% vs 54.0%；Delta = 18.0% [95% CI: 1.0-34.9]；P = .2）。在任一年龄组中，全剂量与半剂量接受者的发烧率均未增加（合计 5.6% 与 12.7%）。结论：给予 2 次全剂量 TIV 剂量可提高免疫原性，而不增加婴儿的反应原性。目前针对幼儿的 TIV 剂量建议值得进一步评估。儿科 2011；128：e276-e289
OBJECTIVES: We assessed whether 2 full versus 2 half-doses of trivalent inactivated influenza vaccine (TIV) could improve immunogenicity without increasing reactogenicity in infants (aged 6-11 months) and toddlers (aged 12-23 months).METHODS: Previously unimmunized infants and toddlers were separately randomly assigned to receive 2 full (0.5-mL) or 2 half (0.25-mL) doses of 2008-2009 split TIV. Sera were collected at enrollment and at 27 to 45 days after the second injection. Parents recorded adverse events after each injection. The primary immunogenicity outcome was superiority (1-sided, alpha = 0.025) of the full versus the half-dose based on a >10% increase in rates of seroprotection (hemagglutination inhibition titer of >= 40). The primary reactogenicity outcome was fever of >= 38 degrees C within 3 days of either injection.RESULTS: In per-protocol analyses, 252 participants (full dose: n = 124; half-dose: n = 128) were included. In toddlers, postimmunization seroprotection rates exceeded 85% for all 3 vaccine components without significant difference by dose. In infants, the full dose induced higher responses for all 3 vaccine components, meeting the 10% test of superiority for the H3N2 (75.4% vs 47.6%; Delta = 27.8% [95% confidence interval (CI): 11.2-44.5]; P = .02) and B/Yamagata (70.2% vs 41.3%; Delta = 28.9% [95% CI: 11.9-45.9]; P = .02) components but not H1N1 (71.9% vs 54.0%; Delta = 18.0% [95% CI: 1.0-34.9]; P = .2). Rates of fever were not increased among full-versus half-dose recipients in either age group (5.6% vs 12.7% combined).CONCLUSIONS: Administration of 2 full TIV doses may improve immunogenicity without increasing reactogenicity in infants. Current TIV dosing recommendations for young children warrant additional evaluation. Pediatrics 2011;128:e276-e289