a National Institutes of Health-University of The Philippines Manila; Manila, The Philippines.
Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280.
Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.
菲律宾、斯里兰卡和印度的监管机构要求进行上市后监测，以在实际环境中提供关于 Rotarix™ 的额外安全性数据。在菲律宾（2006 年 11 月至 2012 年 7 月；NCT00353366）、斯里兰卡（2008 年 11 月至 2009 年 8 月；NCT00779779）和印度（2009 年 8 月至 2010 年 4 月；NCT00938327）进行的这些研究中，根据当地处方信息（PI）给予了 2 剂 Rotarix™。在菲律宾的 15 天内或在斯里兰卡和印度的 8 天内，记录至少 2 级/3 级的不良事件（AE）（发热、呕吐或腹泻）的发生率；在 31 天内记录未征集的 AE 和整个研究期间的严重不良事件（SAE）。在菲律宾、斯里兰卡和印度登记的 1494、522 和 332 名婴儿中，分别有 14.7%、14.9%和 12.7%的婴儿记录了至少 2 级/3 级的征集 AE。报告最多的征集 AE 是菲律宾的烦躁不安（第 1 剂后 32.2%；第 2 剂后 23.5%）和印度的发热（第 1 剂后 23.0%；第 2 剂后 13.2%），斯里兰卡的第 1 剂后发热（18.0%）。在 24.5%（菲律宾）、4.8%（斯里兰卡）和 6.9%（印度）的婴儿中记录了未征集的 AE。在菲律宾记录了 41 例 SAE，其中 6 例（睡眠时间增加和便秘时的口腔摄入量减少；肺炎、尿路感染和肠套叠）被研究者认为与疫苗接种有关。斯里兰卡的一名婴儿发生了 1 例与疫苗无关的 SAE。所有 SAE 均得到解决，婴儿均康复。根据当地 PI，给健康婴儿接种 2 剂 Rotarix™，在菲律宾、斯里兰卡和印度均具有良好的耐受性。
