Department of Paediatrics, KK Women's and Children's Hospital, Singapore 229899, Singapore.
Vaccine. 2012 Jun 22;30(30):4552-7. doi: 10.1016/j.vaccine.2012.03.030. Epub 2012 Apr 10.
RIX4414 (Rotarix™), has shown high efficacy during the first 2-years of life. A 2-year randomized, double-blind, placebo-controlled trial in Singapore, Hong Kong, and Taiwan was extended for another year. Infants (6-17 weeks) received 2-doses (1-2 months apart) of RIX4414 (n=5359) or placebo (n=5349). During the third-year follow-up, 4359 (RIX4414) and 4328 (placebo) infants were monitored. 64 (1.2%) and 2 (0.04%) infants in the placebo and RIX4414 groups, respectively, reported severe rotavirus-gastroenteritis (RVGE), resulting in a vaccine efficacy of 96.9% (95% CI [88.3-99.6]). Efficacy was 100% (67.5-100) in the third-year. RIX4414 was efficacious against G1 (100.0% [84.8-100]) and pooled non-G1 RV types (94.9% [80.2-99.4]). This study shows that the vaccine is highly efficacious, regardless of circulating RV-types, up to the first 3 years of life in affluent Asian urban populations.
RIX4414（RotarixTM）在生命的前 2 年表现出了很高的疗效。一项在新加坡、中国香港和中国台湾进行的为期 2 年的随机、双盲、安慰剂对照试验延长了 1 年。婴儿（6-17 周）接受了 2 剂（相隔 1-2 个月）RIX4414（n=5359）或安慰剂（n=5349）。在第 3 年随访期间，监测了 4359 名（RIX4414）和 4328 名（安慰剂）婴儿。安慰剂组和 RIX4414 组分别有 64 名（1.2%）和 2 名（0.04%）婴儿报告严重轮状病毒胃肠炎（RVGE），疫苗有效性为 96.9%（95%CI[88.3-99.6]）。第 3 年的疗效为 100%（67.5-100）。RIX4414 对 G1（100.0%[84.8-100]）和汇总的非 G1 轮状病毒类型（94.9%[80.2-99.4]）均有效。这项研究表明，该疫苗在富裕的亚洲城市人群中，无论轮状病毒流行类型如何，在生命的前 3 年都具有高度的有效性。
