An open, randomized multi-center trial, involving 700 infants, was conducted in order to compare a new measles mumps rubella (MMR) vaccine, SB MMR (containing a Jeryl Lynn derived mumps strain RIT 4385) with a widely used vaccine, Merck MMR, when given to children between 12-24 months. Infants were divided between 2 groups; group 1 received SB MMR while group 2 received Merck MMR. Solicited local and general symptoms were recorded using diary cards and antibody levels were measured using ELISA assays. There was a significantly lower incidence of redness (p < 0.001) and swelling (p = 0.03) observed in group 1 compared with group 2. The incidence of all other solicited local and general symptoms were comparable between groups. In initially seronegative subjects equivalent seroconversion rates and post-vaccination GMTs were observed between groups. In conclusion, these results demonstrate that SB MMR is safe and well tolerated when given to children at this age range, and has an equivalent immunogenic profile compared to the widely used Merck MMR vaccine.

译文

:进行了一项涉及700名婴儿的开放随机随机多中心试验,目的是比较一种新的麻疹腮腺炎风疹(MMR)疫苗SB MMR(包含Jeryl Lynn衍生的腮腺炎菌株RIT 4385)与一种广泛使用的疫苗默克给12至24个月的儿童服用MMR。婴儿分为两组。第1组收到SB MMR,而第2组收到默克MMR。使用日记卡记录请求的局部和一般症状,并使用ELISA测定法测量抗体水平。与第2组相比,第1组的发红(p <0.001)和肿胀(p = 0.03)发生率显着降低。所有其他引起的局部和一般症状的发生率在各组之间是相当的。在最初的血清阴性受试者中,各组之间观察到了相同的血清转化率和疫苗接种后GMT。总之,这些结果表明,当给该年龄段的儿童服用SB MMR时,它是安全且耐受性良好的,与广泛使用的默克MMR疫苗相比,它具有同等的免疫原性。

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