Kaiser Permanente Vaccine Study Center, Oakland, California;
Kaiser Permanente Colorado Institute for Health Research, Denver and Department of Ambulatory Care Services, Denver Health, Denver, Colorado;
Pediatrics. 2015 Feb;135(2):e321-9. doi: 10.1542/peds.2014-1822. Epub 2015 Jan 5.
All measles-containing vaccines are associated with several types of adverse events, including seizure, fever, and immune thrombocytopenia purpura (ITP). Because the measles-mumps-rubella-varicella (MMRV) vaccine compared with the separate measles-mumps-rubella (MMR) and varicella (MMR + V) vaccine increases a toddler's risk for febrile seizures, we investigated whether MMRV is riskier than MMR + V and whether either vaccine elevates the risk for additional safety outcomes.
Study children were aged 12 to 23 months in the Vaccine Safety Datalink from 2000 to 2012. Nine study outcomes were investigated: 7 main outcomes (anaphylaxis, ITP, ataxia, arthritis, meningitis/encephalitis, acute disseminated encephalomyelitis, and Kawasaki disease), seizure, and fever. Comparing MMRV with MMR + V, relative risk was estimated by using stratified exact binomial tests. Secondary analyses examined post-MMRV or MMR + V risk versus comparison intervals; risk and comparison intervals were then contrasted for MMRV versus MMR+V.
We evaluated 123,200 MMRV and 584,987 MMR + V doses. Comparing MMRV with MMR + V, risks for the 7 main outcomes were not significantly different. Several outcomes had few or zero postvaccination events. Comparing risk versus comparison intervals, ITP risk was higher after MMRV (odds ratio [OR]: 11.3 [95% confidence interval (CI): 1.9 to 68.2]) and MMR + V (OR: 10 [95% CI: 4.5 to 22.5]) and ataxia risk was lower after both vaccines (MMRV OR: 0.8 [95% CI: 0.5 to 1]; MMR + V OR: 0.8 [95% CI: 0.7 to 0.9]). Compared with MMR + V, MMRV increased risk of seizure and fever 7 to 10 days after vaccination.
This study did not identify any new safety concerns comparing MMRV with MMR + V or after either the MMRV or the MMR + V vaccine. This study provides reassurance that these outcomes are unlikely after either vaccine.
所有含麻疹疫苗都会引起多种不良反应，包括癫痫发作、发热和免疫性血小板减少性紫癜（ITP）。由于麻疹-腮腺炎-风疹-水痘（MMRV）疫苗比单独的麻疹-腮腺炎-风疹（MMR）和水痘（MMR+V）疫苗增加了幼儿热性惊厥的风险，我们研究了 MMRV 是否比 MMR+V 更危险，以及两种疫苗是否都会增加其他安全性结果的风险。
这项研究的儿童年龄在 2000 年至 2012 年期间为 12 至 23 个月，来自疫苗安全数据链接。研究了 9 种研究结果：7 种主要结果（过敏反应、ITP、共济失调、关节炎、脑膜炎/脑炎、急性播散性脑脊髓炎和川崎病）、癫痫发作和发热。通过使用分层精确二项式检验比较 MMRV 与 MMR+V，估计相对风险。二次分析检查了 MMRV 或 MMR+V 后的风险与比较间隔；然后对比 MMRV 与 MMR+V 之间的风险和比较间隔。
我们评估了 123200 剂 MMRV 和 584987 剂 MMR+V。与 MMR+V 相比，MMRV 的 7 种主要结果的风险没有显著差异。一些结果的疫苗接种后事件较少或为零。与比较间隔相比，MMRV 后 ITP 风险更高（比值比[OR]：11.3[95%置信区间（CI）：1.9 至 68.2]），MMRV 和 MMR+V 后共济失调风险更低（MMRV OR：0.8[95% CI：0.5 至 1]；MMR+V OR：0.8[95% CI：0.7 至 0.9]）。与 MMR+V 相比，MMRV 疫苗接种后 7 至 10 天增加了癫痫发作和发热的风险。
与 MMR+V 相比，本研究未发现任何新的安全性问题，也未发现 MMRV 或 MMR+V 疫苗接种后的安全性问题。本研究提供了保证，即这两种疫苗接种后不太可能出现这些结果。
