2至3岁儿童二价甲型流感减毒活疫苗的评估：安全性、免疫原性和剂量反应。
Evaluation of bivalent live attenuated influenza A vaccines in children 2 months to 3 years of age: safety, immunogenicity and dose-response.
作者信息
Gruber W C, Darden P M, Still J G, Lohr J, Reed G, Wright P F
机构信息
Department of Pediatrics. Vanderbilt University School of Medicine, Nashville, TN 37232-2581, USA.
出版信息
Vaccine. 1997 Aug-Sep;15(12-13):1379-84. doi: 10.1016/s0264-410x(97)00032-7.
1126 children, 2 months to 3 years old, received a single intranasal dose of 10(4), 10(6), or 10(7) TCID50 of cold adapted (ca) A/Kawasaki/9/86 (H1N1) and A/Beijing/352/89 (H3N2) or placebo, in a double blind, placebo-controlled, safety and immunogenicity trial. No reactogenicity attributable to vaccine was demonstrated. A single bivalent 10(6) or 10(7) dose produced high rates of seroconversion to H1N1 (77%) and H3N2 (92%) in seronegative children > 6 months old; serologic responses were lower to H1N1 (P < 0.001) and H3N2 (P = 0.01) in younger infants. A single 10(6) dose of bivalent ca influenza A vaccine can be immunogenic in children, but response is age dependent.
在一项双盲、安慰剂对照的安全性和免疫原性试验中，1126名2个月至3岁的儿童接受了单剂量鼻内接种10⁴、10⁶或10⁷半数组织培养感染剂量（TCID₅₀）的冷适应A/川崎/9/86（H1N1）和A/北京/352/89（H3N2）流感疫苗或安慰剂。未发现可归因于疫苗的反应原性。单剂量二价10⁶或10⁷疫苗在6个月以上血清阴性儿童中产生了高血清转化率，对H1N1的血清转化率为77%，对H3N2的血清转化率为92%；在较小婴儿中，对H1N1（P<0.001）和H3N2（P = 0.01）的血清学反应较低。单剂量10⁶二价冷适应甲型流感疫苗对儿童具有免疫原性，但反应取决于年龄。
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