Kinder-Jugendarztpraxis, Wildeshausen, Germany.
Pediatr Infect Dis J. 2012 Nov;31(11):1166-72. doi: 10.1097/INF.0b013e318267fd8b.
ProQuad, a vaccine containing antigens from M-M-RVAXPRO (measles, mumps and rubella vaccine) and VARIVAX (varicella vaccine), is indicated for simultaneous vaccination against measles, mumps, rubella and varicella (MMRV) in individuals from 12 months of age. To eliminate blood-derived products of human origin from the manufacturing process of the MMRV vaccine, recombinant human albumin was selected as a replacement for human serum albumin.
This open-label, multicenter clinical trial (clinicaltrials.gov identifier NCT00560755) was designed to describe the safety profile of a 2-dose schedule of the MMRV vaccine at a 1-month interval in healthy children aged 12-22 months.
In total, 3388 children received at least 1 dose of the MMRV vaccine. Overall, 3376 (99.65%) children were included in the post-dose 1 safety analysis and 3342 (98.64%) in the post-dose 2 safety analysis. After doses 1 and 2, the frequencies of children experiencing solicited injection-site reactions (post-dose 1: erythema 14.31%; swelling 5.57% and pain 10.31%; post-dose 2: erythema 30.46%; swelling 13.23% and pain 11.49%), rashes of interest (post-dose 1: 11.4%; post-dose 2: 2.78%), vaccine-related nonserious systemic adverse events (post-dose 1: 34.86%; post-dose 2: 13.4%) and temperature ≥39.4 °C (post-dose 1: 25.24%; post-dose 2: 12.06%) were consistent with those observed in previous studies of the MMRV vaccine manufactured with human serum albumin. Neither serious allergic-type adverse events nor anaphylactic reactions were reported.
The results confirm the good safety profiles of MMRV and of measles, mumps and rubella vaccines manufactured with recombinant human albumin.
ProQuad 是一种疫苗，包含 M-M-RVAXPRO（麻疹、腮腺炎和风疹疫苗）和 VARIVAX（水痘疫苗）的抗原，用于 12 个月及以上个体同时预防麻疹、腮腺炎、风疹和水痘（MMRV）。为了在 MMRV 疫苗的生产过程中消除源自人血的产品，选择重组人白蛋白替代人血清白蛋白。
这是一项开放标签、多中心临床试验（clinicaltrials.gov 标识符 NCT00560755），旨在描述 12-22 月龄健康儿童接受间隔 1 个月的 2 剂 MMRV 疫苗的安全性概况。
共有 3388 名儿童至少接受了 1 剂 MMRV 疫苗。总体而言，3376 名（99.65%）儿童纳入了第 1 剂后安全性分析，3342 名（98.64%）儿童纳入了第 2 剂后安全性分析。在第 1 剂和第 2 剂后，经历注射部位反应（第 1 剂后：红斑 14.31%；肿胀 5.57%和疼痛 10.31%；第 2 剂后：红斑 30.46%；肿胀 13.23%和疼痛 11.49%）、有意义的皮疹（第 1 剂后：11.4%；第 2 剂后：2.78%）、疫苗相关非严重全身不良事件（第 1 剂后：34.86%；第 2 剂后：13.4%）和体温≥39.4°C（第 1 剂后：25.24%；第 2 剂后：12.06%）的儿童比例与以前使用人血清白蛋白生产的 MMRV 疫苗研究中观察到的比例一致。均未报告严重过敏样不良事件或过敏反应。
结果证实了 MMRV 疫苗和使用重组人白蛋白生产的麻疹、腮腺炎和风疹疫苗的良好安全性。
