Klopfer Stephanie O, Stek Jon E, Petrecz Maria, Reisinger Keith S, Black Steven B, Goveia Michelle G, Nicholson Ouzama, Gardner Julie L, Grosso Anthony D, Brown Michelle L, Kuter Barbara J, Schödel Florian P
Merck & Co., Inc, Whitehouse Station, NJ, United States.
Merck & Co., Inc, Whitehouse Station, NJ, United States.
Vaccine. 2014 Dec 12;32(52):7154-60. doi: 10.1016/j.vaccine.2014.08.067. Epub 2014 Sep 16.
In randomized clinical studies, over 11,800 children, 12 months to 6 years of age, were administered ProQuad(®), a combination measles, mumps, rubella, and varicella vaccine (MMRV). This paper describes the safety following a 2-dose regimen of MMRV administered to children in the second year of life.
Safety data from five clinical studies were combined for all children who were scheduled to receive two doses of MMRV ∼3-6 months apart. All vaccinated children were followed for safety following each dose of MMRV.
Of 3112 children who received a first dose of MMRV, 2780 (89.3%) received a second dose of MMRV. Overall, 70.5% and 57.7% of children reported ≥1 adverse experiences following first and second doses of MMRV, respectively. Injection-site redness was statistically significantly higher postdose 2 than postdose 1, while injection-site pain/tenderness was statistically significantly higher postdose 1 compared to postdose 2. Rashes were statistically significantly lower postdose 2 compared to postdose 1. Ten febrile seizures (8 postdose 1, 2 postdose 2) were reported following MMRV vaccination. The incidence of febrile seizures postdose 1 of MMRV was 0.26% (8/3019) compared to 0.07% (2/2695) postdose 2 of MMRV.
Administration of two doses of MMRV has an acceptable safety profile in children 12 to 23 months of age. There is a small increase in the risk of febrile seizures following the first dose of MMRV as compared to the component vaccines, but the risk for any individual child is relatively low.
在随机临床研究中，超过11800名12个月至6岁的儿童接种了ProQuad（®），这是一种麻疹、腮腺炎、风疹和水痘联合疫苗（MMRV）。本文描述了在生命第二年给儿童接种两剂MMRV后的安全性。
汇总五项临床研究中所有计划间隔约3 - 6个月接种两剂MMRV的儿童的安全性数据。所有接种疫苗的儿童在每次接种MMRV后均进行安全性随访。
在3112名接种第一剂MMRV的儿童中，2780名（89.3%）接种了第二剂MMRV。总体而言，分别有70.5%和57.7%的儿童在接种第一剂和第二剂MMRV后报告了≥1次不良事件。注射部位发红在接种第二剂后在统计学上显著高于接种第一剂后，而注射部位疼痛/压痛在接种第一剂后与接种第二剂后相比在统计学上显著更高。皮疹在接种第二剂后与接种第一剂后相比在统计学上显著更低。接种MMRV后报告了10例热性惊厥（接种第一剂后8例，接种第二剂后2例）。MMRV接种第一剂后的热性惊厥发生率为0.26%（8/3019），而MMRV接种第二剂后的发生率为0.07%（2/2695）。
在12至23个月大的儿童中接种两剂MMRV具有可接受的安全性。与各组分疫苗相比，接种第一剂MMRV后热性惊厥的风险略有增加，但任何个体儿童的风险相对较低。
