BACKGROUND:Vaccines against hepatitis A provide long-lasting protection in both adults and children. The aim of this study was to demonstrate that the inactivated hepatitis A vaccine AVAXIM 80U Pediatric is safe and not inferior in terms of seroprotection rate to HAVRIX 720 vaccine 1 month after booster vaccination. METHODS:An open, randomized, single-center trial was conducted in China in healthy antihepatitis A virus seronegative individuals from 12 months to 15 years of age. Participants were randomized in a 2:1 ratio to receive either AVAXIM 80U Pediatric or HAVRIX 720, followed by a booster vaccination, using the same vaccine 6 months afterward. RESULTS:A total of 720 individuals were included in the study, 480 in the AVAXIM 80U Pediatric group and 240 in the HAVRIX 720 group, and 686 individuals completed the full vaccination schedule. AVAXIM 80U Pediatric was statistically noninferior to HAVRIX 720 in terms of seroprotection rate for all individuals and in each of 3 age groups: toddlers (12-23 months), children (2-11 years) and adolescents (12-15 years). Antihepatitis A virus geometric mean titers were significantly higher with AVAXIM 80U Pediatric than with HAVRIX 720. Both inactivated hepatitis A vaccines were well-tolerated and had a similar incidence and type of adverse events. CONCLUSION:AVAXIM 80U Pediatric is safe and immunogenic, with a seroprotection rate that is not inferior to HAVRIX 720 in a pediatric population of healthy individuals.

译文

背景:抗甲型肝炎疫苗对成人和儿童均提供长期的保护。这项研究的目的是证明灭活的甲型肝炎疫苗AVAXIM 80U儿科疫苗加强免疫后1个月,其血清保护率相对于HAVRIX 720疫苗而言并不逊色。
方法:在中国进行了一项开放,随机,单中心试验,研究对象是健康的抗12个月至15岁的甲型肝炎病毒血清阴性个体。参与者以2:1的比例随机分配,以接受AVAXIM 80U Pediatric或HAVRIX 720,然后在6个月后使用相同的疫苗进行加强免疫。
结果:总共720人被纳入研究,AVAXIM 80U儿科组为480人,HAVRIX 720组为240人,有686人完成了完整的疫苗接种时间表。就所有个体以及三个年龄组中的每个年龄组(幼儿(12-23个月),儿童(2-11岁)和青少年(12-15岁))的血清保护率而言,AVAXIM 80U儿科在统计学上均不逊于HAVRIX 720。 AVAXIM 80U儿科患者的抗A型肝炎病毒几何平均滴度显着高于HAVRIX720。两种灭活的A型肝炎疫苗均具有良好的耐受性,并且不良事件的发生率和类型相似。
结论:AVAXIM 80U儿科是安全且具有免疫原性的,其血清保护率不低于健康个体儿科患者的HAVRIX 720。

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