Buyse Hubert, Vinals Carlota, Karkada Naveen, Han Htay Htay
GlaxoSmithKline Vaccines; Wavre, Belgium.
GlaxoSmithKline Vaccines; Bangalore, India.
Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
An integrated analysis of safety and reactogenicity data was undertaken for 28 randomized, placebo-controlled, double-blind Phase II and III trials (DBRCTs) of the oral live-attenuated human rotavirus vaccine, Rotarix™ (GlaxoSmithKline Vaccines). Healthy infants aged 6-20 wk received 2 or 3 doses of vaccine (n=56562) or placebo (n=45512) at 4- to 8-wk intervals. Solicited adverse events (AEs) were recorded for 8 d after each dose of vaccine or placebo. Unsolicited AEs, serious AEs (SAEs), and deaths were evaluated over 31-d post-vaccination follow-up periods. 95% confidence intervals (CIs) for the relative risk (RR) across studies excluding "1.0" signified potential imbalances between the 2 groups. The incidence of each solicited AE of any or Grade 3 severity was similar between groups. The incidence of all unsolicited AEs of any (RR=0.99 [95% CI: 0.94-1.04]; P=0.72) or Grade 3 severity (RR=0.91 [95% CI: 0.77-1.08]; P=0.31) was similar between groups. A significantly higher proportion of SAEs were reported in the placebo group compared with the vaccine group (RR=0.9 [95% CI: 0.82-0.98]; P=0.01). The incidence of death was low and similar between the 2 groups (0.13% in the vaccine group and 0.11% in the placebo group; RR=1.14 [95% CI: 0.78-1.68]; P=0.54). Very few cases of intussusception were reported (11 and 7 in the vaccine and placebo groups, respectively; RR=1.39 [95% CI: 0.49-4.27]; P=0.66). In conclusion, results of this analysis of DBRCTs show that the human rotavirus vaccine Rotarix™ has a reactogenicity and safety profile similar to placebo.
对口服减毒活人类轮状病毒疫苗Rotarix™（葛兰素史克疫苗公司生产）的28项随机、安慰剂对照、双盲II期和III期试验（双盲随机对照试验）的安全性和反应原性数据进行了综合分析。6至20周龄的健康婴儿以4至8周的间隔接受2或3剂疫苗（n = 56562）或安慰剂（n = 45512）。在每次接种疫苗或安慰剂后记录8天内的主动报告不良事件（AE）。在接种疫苗后的31天随访期内评估被动报告不良事件、严重不良事件（SAE）和死亡情况。排除“1.0”的各研究相对风险（RR）的95%置信区间（CI）表明两组之间可能存在失衡。两组中任何严重程度或3级严重程度的每种主动报告不良事件的发生率相似。两组中任何严重程度（RR = 0.99 [95% CI：0.94 - 1.04]；P = 0.72）或3级严重程度（RR = 0.91 [95% CI：0.77 - 1.08]；P = 0.31）的所有被动报告不良事件的发生率相似。与疫苗组相比，安慰剂组报告的严重不良事件比例显著更高（RR = 0.9 [95% CI：0.82 - 0.98]；P = 0.01）。死亡发生率较低，两组相似（疫苗组为0.13%，安慰剂组为0.11%；RR = 1.14 [95% CI：0.78 - 1.68]；P = 0.54）。报告了极少数肠套叠病例（疫苗组和安慰剂组分别为11例和7例；RR = 1.39 [95% CI：0.49 - 4.27]；P = 0.66）。总之，这项双盲随机对照试验分析结果表明，人类轮状病毒疫苗Rotarix™的反应原性和安全性与安慰剂相似。
