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