Osaka Rosai Hospital, Osaka, 1179-3 Nagasonecho, Kita-Ku, Sakai-City, Osaka, Japan.
Vaccine. 2011 Aug 26;29(37):6335-41. doi: 10.1016/j.vaccine.2011.05.017. Epub 2011 Jun 2.
A phase III, randomized, double-blind study evaluated the efficacy, reactogenicity, safety and immunogenicity of a human rotavirus vaccine, RIX4414 in Japanese infants aged 6-14 weeks when administered as two doses (0, 1-month schedule). Efficacy against any and severe rotavirus gastroenteritis leading to medical intervention caused by circulating wild-type rotavirus from two weeks post-Dose 2 until two years of age was 79.3% (95% CI: 60.5-89.8%) and 91.6% (95% CI: 62.4-99.1%), respectively. Solicited, unsolicited symptoms and serious adverse events were reported at a similar frequency in both groups. Serum anti-rotavirus antibody seroconversion rate one-month post-Dose 2 was 85.3% (95% CI: 68.9-95%) in RIXX4414 group. RIX4414 was efficacious, well-tolerated and immunogenic in Japanese infants and introduction of vaccination could help in reducing the disease burden.
一项 III 期、随机、双盲研究评估了 RIX4414 （人轮状病毒疫苗）在 6-14 周龄日本婴儿中的疗效、反应原性、安全性和免疫原性，当以两剂（0、1 月龄方案）给药时。在第 2 剂后 2 周至 2 岁时，针对由循环野生型轮状病毒引起的任何严重轮状病毒胃肠炎导致医疗干预的效力分别为 79.3%（95%CI：60.5-89.8%）和 91.6%（95%CI：62.4-99.1%）。两组报告的不良反应发生率相似。在第 2 剂后 1 个月，血清抗轮状病毒抗体转化率在 RIX4414 组为 85.3%（95%CI：68.9-95%）。RIX4414 在日本婴儿中有效且耐受良好，具有免疫原性，疫苗接种的引入可以帮助减轻疾病负担。
