Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: A randomized, placebo-controlled trial in China

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Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
January 2014  Volume 10, Issue 1
http://www.landesbioscience.com/journals/vaccines/toc/volume/10/issue/1/

Research Paper
 Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: A randomized, placebo-controlled trial in China
Rong-cheng Li, Teng Huang, YanPing Li, Dong Luo, Junhui Tao, Botao Fu, Guoai Si, Yi Nong, Zhaojun Mo, XueYan Liao, Ivy Luan, Haiwen Tang, Niraj Rathi, Naveen…
http://dx.doi.org/10.4161/hv.26319

Abstract
Rotaviruses (RV) are a major cause of severe gastroenteritis (GE) in children aged <5 y. For the first time in China, we assessed the efficacy of two oral doses of the human rotavirus vaccine (RIX4414) in infants during the first two years of life (113808/NCT01171963). Healthy infants aged 6–16 weeks were randomized (1:1) to receive two oral doses of either the RIX4414 vaccine/placebo according to a 0, 1 month schedule. Vaccine efficacy (VE) against severe RVGE was assessed from two weeks post-Dose 2 up until the end of the second RV season and calculated with its 95% confidence intervals (CI). The primary efficacy objective was met if the lower limit of the 95% CI on VE was ≥10%. Unsolicited symptoms reported during the 31-d post-vaccination follow-up period and serious adverse events (SAEs) reported throughout the study were assessed. Of 3333 enrolled infants, 3148 were included in the according-to-protocol efficacy cohort. Over two consecutive RV seasons, fewer severe RVGE episodes were reported in the RIX4414 group (n = 21) vs. the placebo group (n = 75). VE against severe RVGE was 72% (95% CI: 54.1–83.6); the lower limit of the 95% CI on VE was >10%. The number of unsolicited symptoms and SAEs reported was similar between both groups. Thirteen deaths (RIX4414 = 6; placebo = 7) occurred during the study. All SAEs and deaths in the RIX4414 group were considered unrelated to vaccination. Two oral doses of RIX4414 vaccine provided a substantial level of protection against severe RVGE in Chinese children during the first two years of life.