A comparison of 2 influenza vaccine schedules in 6-to 23-month-old children

A comparison of 2 influenza vaccine schedules in 6-to 23-month-old children
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DOI:
10.1542/peds.2004-2373
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发表时间:
2005-04-01
期刊:
影响因子:
8
通讯作者:
Neuzil, KM
Neuzil, KM
中科院分区:
医学2区
文献类型:
--
作者:
Englund, JA;Walter, EB;Neuzil, KM

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背景资料。建议所有6至23个月大的儿童接种三价灭活流感疫苗。给第一次接种这种疫苗的幼儿提供至少4周间隔的2剂TIV是具有挑战性的。在6至23个月大的健康幼儿中,我们比较了标准的两剂TIV秋季接种方案和早期春季接种后秋季接种相同疫苗的方案的免疫原性和反应性。儿童在春季被招募,被随机分成标准时间表或提前时间表。另一组也在秋季作为非随机化标准对照组的一部分被招募。2002-2003年获得许可的TIV在春季接种;2003-2004年秋季疫苗含有相同的3种抗原成分。通过父母日记和电话监测来评估反应性。所有儿童在第二次TIV后采血。主要结果是两剂疫苗接种后对甲型H1N1、甲型H3N1和乙型流感的抗体应答,血凝抑制滴度和几何平均滴度(GMT)为1:32。219名儿童随机接受标准或早期TIV方案;另有40名儿童在秋季加入非随机化标准组。综合标准组和早期组的总体应答率相似:对H1N1的应答率为78%(GMT:48)比76%(GMT:57),对H3N2的应答率为89%(GMT:115)比88%(GMT:129),对B组的应答率为52%(GMT:24)比60%(GMT:28)。两组儿童TIV的反应性都很低,不随剂量、年龄或剂量之间的时间而异。与单独接种TIV的人相比,接受TIV和伴随疫苗的人的反应率更高。腋下38℃和注射部位疼痛、红肿和肿胀的总发生率分别为5.4%、3.1%、0.9%和1.1%。当春季和秋季流感疫苗具有相同的3种抗原成分时,早期疫苗方案与标准方案相比具有相似的免疫原性和反应性。当疫苗成分在不同年份之间没有变化时,在春季例行办公室访问时启动流感疫苗将有助于在季节较早的时候为儿童全面接种流感疫苗。
Background. Trivalent inactivated influenza vaccine (TIV) is recommended for all children ages 6 to 23 months. Delivering 2 doses of TIV at least 4 weeks apart to young children receiving this vaccine for the first time is challenging.Methods. We compared the immunogenicity and reactogenicity of the standard 2-dose regimen of TIV administered in the fall with an early schedule of a single spring dose followed by a fall dose of the same vaccine in healthy toddlers 6 to 23 months of age. Children were recruited in the spring to be randomized into either the standard or early schedule. An additional group was also enrolled in the fall as part of a nonrandomized standard comparison group. The 2002-2003 licensed TIV was administered in the spring; the fall 2003-2004 vaccine contained the same 3 antigenic components. Reactogenicity was assessed by parental diaries and telephone surveillance. Blood was obtained after the second dose of TIV for all children. The primary outcome measure was antibody response to influenza A/H1N1, A/H3N2, and B after 2 doses of vaccine, as determined by hemagglutination-inhibition titers >= 1: 32 and geometric mean titer (GMT).Results. Two hundred nineteen children were randomized to receive either the standard or early TIV schedule; 40 additional children were enrolled in the fall in the nonrandomized standard group. Response rates in the combined standard versus early groups were similar overall: 78% (GMT: 48) vs 76% (GMT: 57) to H1N1, 89% (GMT: 115) vs 88% (GMT: 129) to H3N2, and 52% (GMT: 24) vs 60% (GMT: 28) to B. Reactogenicity after TIV in both groups of children was minimal and did not differ by dose, age, or time between doses. Reaction rates were higher in those receiving TIV and concomitant vaccines compared with those receiving TIV alone. Overall rates of fever >38 degrees C axillary and injection-site pain, redness, or swelling were 5.4%, 3.1%, 0.9%, and 1.1%, respectively.Conclusions. When the spring and fall influenza vaccines had the same 3 antigenic components, the early vaccine schedule resulted in similar immunogenicity and reactogenicity compared with the standard schedule. When the vaccine components do not change between years, initiating influenza vaccine in the spring at the time of routine office visits would facilitate full immunization of children against influenza earlier in the season.