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首页> 外文期刊>Vaccine >Reactogenicity and immunogenicity of a new combined Measles-Mumps-Rubellavaccine: results of a multicentre trial
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Reactogenicity and immunogenicity of a new combined Measles-Mumps-Rubellavaccine: results of a multicentre trial

机译：新型麻疹-腮腺炎-核糖核酸疫苗联合的反应原性和免疫原性：一项多中心试验的结果

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A large single blind, multi-centre study involving 1779 children was performed in Italy. Infants, aged between 12 and 27 months were divided between two groups: group A received a single dose of a new MMR vaccine, 'Priorix'(3) while group B received a widely used MMR vaccine, Triviraten(4). Solicited local and general symptoms were recorded using diary cards and antibody levels were measured, prior to and 60 days post-vaccination, using ELISA assays. The incidence of solicited symptoms (evaluated in 1754 subjects) was comparable between groups, with the exception of fever which was significantly lower in group B. Immunogenicity was evaluated in 686 subjects. Of note, was the significantly higher anti-mumps seroconversion rate (p < 0.001) observed in group A (97.0%) compared to group B (35.4%). However the anti-measles and anti-rubella seroconversion rates were equivalent between groups. Significantly higher (p < 0.001) post-vaccination GMTs were in group A vs group B for anti-measles (2830 vs 784 IU/ml) and anti-mumps (1640 vs 469 U/ml), however the anti-rubella GMTs were significantly higher (p < 0.001) in group B (117.6 IU/ml) compared to group A (92.6 IU/ml). The persistence of antibodies in 35 subjects was assessed 1 year after vaccination and the results showed no appreciable decline in titres with either vaccine. The trial demonstrates 'Priorix' is well tolerated and highly immunogenic, (C) 2000 Elsevier Science Ltd. All rights reserved.
机译：在意大利进行了一项涉及1779名儿童的大型单盲，多中心研究。年龄在12到27个月之间的婴儿分为两组：A组接受单剂量的新MMR疫苗“ Priorix”（3），而B组接受广泛使用的MMR疫苗Triviraten（4）。使用日记卡记录所请求的局部和一般症状，并在免疫前和免疫后60天使用ELISA测定法测量抗体水平。各组之间征集症状的发生率（在1754名受试者中进行了评估）在两组之间是可比的，但发烧除外（B组的发烧明显更低）。在686名受试者中评估了免疫原性。值得注意的是，与B组（35.4％）相比，A组（97.0％）的抗腮腺炎血清转换率（p <0.001）显着更高。但是，两组之间的抗麻疹和抗风疹血清转化率相同。 A组与B组的抗麻疹（2830 vs 784 IU / ml）和抗腮腺炎（1640 vs 469 U / ml）的接种后GMT显着更高（p <0.001），但是抗风疹GMTs与A组（92.6 IU / ml）相比，B组（117.6 IU / ml）显着更高（p <0.001）。疫苗接种1年后评估了35名受试者的抗体持久性，结果显示两种疫苗的滴度均无明显下降。该试验表明“ Priorix”具有良好的耐受性和高度免疫原性，（C）2000 Elsevier ScienceLtd。保留所有权利。

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