Vaccine. 2020 Jul 14;38(33):5241-5248. doi: 10.1016/j.vaccine.2020.05.093. Epub 2020 Jun 16.
Pre-licensure trials of ROTAVAC® were not adequately powered to assess risk of intussusception, a rare adverse event associated with other rotavirus vaccines in some settings. We examined the risk of intussusception after ROTAVAC® vaccination among Indian infants during pilot rollout of the vaccine in the public health system in three states - Himachal Pradesh, Maharashtra and Tamil Nadu.
Passive surveillance for intussusception was set up in 35 sentinel health facilities covering 26.3 million population in the three states under monitoring of an Interministerial-Interagency Steering Committee. Clinical and immunization data were collected by independent teams. An expert committee blinded to vaccination status, classified intussusception cases using Brighton criteria. The self-controlled case-series method was used to estimate risk of intussusception (Brighton Level 1) after ROTAVAC® vaccination.
151 intussusception cases were included in the analysis. The relative incidence (incidence during the risk period compared to the control period) 1-21 days after doses 1 and 2 combined was 1.56 (95% CI, 0.0-5.28) and that for three doses combined was 1.88 (95% CI, 0.76-4.30). Attributable risk 1-21 days after doses 1 and 2 combined was 0.11 (95% CI, 0.0-0.25) and that for 3 doses combined was 0.42 (95% CI, 0.0-0.70) per 100,000 doses.
No increased risk of intussusception within 21 days of receipt of the first two doses combined or all 3 doses combined of ROTAVAC® was detected.
ROTAVAC® 的上市前试验没有足够的效力来评估与其他轮状病毒疫苗在某些情况下相关的罕见不良事件——肠套叠的风险。我们在印度三个邦（喜马偕尔邦、马哈拉施特拉邦和泰米尔纳德邦）的公共卫生系统中，对 ROTAVAC®疫苗在试点推广阶段接种后发生肠套叠的风险进行了研究。
在三个邦的 35 个哨点卫生机构中建立了肠套叠的被动监测，由部际-机构间指导委员会进行监测，覆盖 2630 万人口。临床和免疫接种数据由独立团队收集。一个对疫苗接种状况不知情的专家委员会使用布莱顿标准对肠套叠病例进行分类。使用自身对照病例系列法估计 ROTAVAC®接种后肠套叠的风险（布莱顿一级）。
共有 151 例肠套叠病例纳入分析。1 剂和 2 剂联合接种后 1-21 天的相对发病率（风险期与对照期相比）为 1.56（95%可信区间，0.0-5.28），3 剂联合接种后的相对发病率为 1.88（95%可信区间，0.76-4.30）。1 剂和 2 剂联合接种后 1-21 天的归因风险为 0.11（95%可信区间，0.0-0.25），3 剂联合接种后的归因风险为 0.42（95%可信区间，0.0-0.70）每 10 万剂。
在接种前两剂联合或全部 3 剂 ROTAVAC®后 21 天内，未发现肠套叠风险增加。
