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一种儿科剂型流感疫苗的安全性和免疫原性。

Safety and immunogenicity of a paediatric presentation of an influenza vaccine.

作者信息

Gonzalez M, Pirez M C, Ward E, Dibarboure H, García A, Picolet H

机构信息

Centro Materno-Infantil Maciel, Montevideo, Uruguay.

出版信息

Arch Dis Child. 2000 Dec;83(6):488-91. doi: 10.1136/adc.83.6.488.

Abstract

BACKGROUND

Flu vaccination in otherwise healthy infants and young children is important to prevent severe disease, as well as to control epidemic spread of influenza infection.

AIMS

To examine the safety and immunogenicity of a paediatric presentation of a purified, inactivated, triton split influenza vaccine.

METHODS

Two doses of the vaccine, provided in prefilled syringes of 0.25 ml, were administered, one month apart, to 67 children under 3 years of age.

RESULTS

Nine cases of immediate reaction to vaccination (macules/papules) were observed after the second injection only. During the study period, 9% of children experienced at least one delayed local reaction, and 28% of children presented at least one systemic reaction. Almost all reactions were mild and transient. Immunogenicity results surpassed the European Community recommendations for a 0.50 ml dose of vaccine in adults.

CONCLUSION

This paediatric formulation of inactivated flu vaccine appears safe and immunogenic in children from 6 months to 3 years of age; the convenient presentation in a prefilled syringe of 0.25 ml volume will facilitate administration of the dose recommended for young children.

摘要

背景

对健康的婴幼儿进行流感疫苗接种对于预防严重疾病以及控制流感感染的流行传播至关重要。

目的

研究一种儿科用纯化、灭活、吐温裂解流感疫苗的安全性和免疫原性。

方法

给67名3岁以下儿童接种两剂预充式0.25毫升注射器装的疫苗,间隔1个月。

结果

仅在第二次注射后观察到9例接种疫苗后的即刻反应(斑疹/丘疹)。在研究期间,9%的儿童经历了至少一次延迟性局部反应,28%的儿童出现了至少一次全身反应。几乎所有反应均为轻度且短暂的。免疫原性结果超过了欧洲共同体对成人0.50毫升剂量疫苗的建议。

结论

这种儿科剂型的灭活流感疫苗在6个月至3岁儿童中似乎是安全且具有免疫原性的;预充式0.25毫升注射器的便利剂型将便于给予幼儿推荐剂量。

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