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重组三价流感疫苗(Flublok(®)):在成人季节性流感预防中的应用综述。

Recombinant trivalent influenza vaccine (flublok(®)): a review of its use in the prevention of seasonal influenza in adults.

机构信息

Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754 Auckland, New Zealand.

出版信息

Drugs. 2013 Aug;73(12):1357-66. doi: 10.1007/s40265-013-0103-6.

Abstract

Flublok(®) is a trivalent influenza vaccine manufactured using the baculovirus-insect cell system, which has a number of differences compared with the traditional embryonated chicken egg system. Flublok(®) is the first vaccine containing recombinant protein to be approved for the prevention of seasonal influenza, and is indicated in the USA in adults aged 18-49 years. In a large, placebo-controlled, phase III trial in individuals aged 18-49 years, Flublok(®) met the US FDA requirements for immunogenicity, effectiveness and safety, despite a high incidence of antigenic mismatch between confirmed cases of influenza and the vaccine component strains. Flublok(®) was also compared with Fluzone(®) in two noninferiority trials in older adults aged 50-64 or ≥65 years; although noninferiority was shown for a number of endpoints in these trials, Flublok(®) is not currently approved in these age groups. Flublok(®) is a useful and generally well-tolerated vaccination option for the prevention of seasonal influenza in adults aged 18-49 years, including those with egg allergy.

摘要

福必乐(®)是一种三价流感疫苗,采用杆状病毒-昆虫细胞系统生产,与传统的鸡胚系统相比有许多不同。福必乐(®)是首个获批用于预防季节性流感的重组蛋白疫苗,在美国适用于 18-49 岁成年人。在一项针对 18-49 岁个体的大型、安慰剂对照、III 期试验中,尽管流感确诊病例与疫苗成分株之间存在高度抗原错配,但福必乐(®)满足了美国 FDA 对免疫原性、有效性和安全性的要求。福必乐(®)还在两项针对 50-64 岁或≥65 岁老年人的非劣效性试验中与 Fluzone(®)进行了比较;尽管这些试验中的多个终点显示非劣效性,但福必乐(®)目前尚未在这些年龄组中获得批准。福必乐(®)是一种有用且通常耐受性良好的疫苗选择,可用于预防 18-49 岁成年人的季节性流感,包括对鸡蛋过敏的人群。

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