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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007.
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Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007.

机译：2006年2月1日至2007年9月25日，在美国进行RotaTeq疫苗接种后，对肠套叠进行事后监测。

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BACKGROUND: In 1999, a previous rotavirus vaccine (RotaShield; Wyeth Laboratories, Marietta, PA) was withdrawn from the US market after postlicensure monitoring identified an association with intussusception. Although the new rotavirus vaccine (RotaTeq; Merck, West Point, PA) introduced in 2006 was not associated with intussusception in prelicensure trials, additional monitoring is important to ensure a complete safety profile. METHODS: We assessed intussusception reports after RotaTeq vaccination by using data from the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink, a cohort of children enrolled in managed care. Observed versus expected rate ratios were determined by using vaccine dose distribution data and Vaccine Safety Datalink background intussusception rates. RESULTS: Between February 1, 2006, and September 25, 2007, the Vaccine Adverse Event Reporting System received 160 intussusception reports after RotaTeq vaccination. With the assumptions that reporting completeness was 75% and that 75% of the distributed doses of RotaTeq were administered, the observed versus expected rate ratios were 0.53 and 0.91 for the 1-21 and 1-7 day interval after vaccination, respectively. In the Vaccine Safety Datalink, 3 intussusception cases occurred within 30 days after 111521 RotaTeq vaccinations, compared with 6 cases after 186722 non-RotaTeq vaccinations during the same period. If, like RotaShield, RotaTeq had a 37-fold increased risk of intussusception within 3 to 7 days after vaccination, then 8 intussusception cases would be expected within 3 to 7 days among the approximately 84000 infants vaccinated with the first dose of RotaTeq in the Vaccine Safety Datalink (N = 49902) and the prelicensure trial (N = 34035) combined, whereas no cases have been observed. CONCLUSIONS: Available data do not indicate that RotaTeq is associated with intussusception. Although an intussusception risk similar in magnitude to that of RotaShield can be excluded, continued monitoring is necessary for completeassessment of the safety profile of RotaTeq.
机译：背景：1999年，在获得许可后监测发现与肠套叠相关之后，先前的轮状病毒疫苗（RotaShield;惠氏实验室，宾夕法尼亚州玛丽埃塔）被从美国市场撤出。尽管2006年推出的新轮状病毒疫苗（RotaTeq;默克公司，宾夕法尼亚州西点）在许可前试验中与肠套叠无关，但额外的监测对于确保完整的安全性至关重要。方法：我们通过使用疫苗不良事件报告系统和疫苗安全数据链中的数据评估了RotaTeq疫苗接种后的肠套叠报告。通过使用疫苗剂量分布数据和疫苗安全性数据链接背景肠套叠率确定观察到的与预期的比率。结果：在2006年2月1日至2007年9月25日期间，疫苗不良事件报告系统在RotaTeq疫苗接种后收到了160次肠套叠报告。假设报告的完整性为75％，并且已施用RotaTeq的75％的分散剂量，则接种后1-21天和1-7天的间隔观察到的预期比率与预期比率分别为0.53和0.91。在疫苗安全数据链中，在111521 RotaTeq疫苗接种后的30天内发生了3例肠套叠病例，而同期186722非RotaTeq疫苗接种后有6例。如果像RotaShield一样，RotaTeq在疫苗接种后3至7天内肠套叠的风险增加了37倍，那么在大约84000接种了首剂RotaTeq疫苗的婴儿中，预计3至7天内会有8例肠套叠病例安全数据链（N = 49902）和许可前试验（N = 34035）结合在一起，但没有发现任何病例。结论：现有数据并不表明RotaTeq与肠套叠有关。尽管可以排除大小与RotaShield相似的肠套叠风险，但仍需要持续监测以完整评估RotaTeq的安全性。

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