Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers
Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers
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DOI：
10.1016/j.vaccine.2012.03.080
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发表时间：
2012-06-06
期刊：
影响因子：
5.5
通讯作者：
Dull, Peter
中科院分区：
文献类型：
--
作者：
Klein, Nicola P.;Shepard, Julie;Dull, Peter
背景：侵袭性脑膜炎双球菌疾病可造成灾难性后果，特别是在婴儿等高危人群中。由于婴儿被建议在一次就诊期间接种多种疫苗，这项第三阶段研究评估了12个月大婴儿交替就诊时使用MenACVVY-CRM以及与麻疹、腮腺炎、风疹、水痘疫苗(MMRV)同时使用的安全性和免疫应答。方法：同时纳入两个年龄组：7-9个月婴儿在7-9个月和12个月时接种2剂MenACWY-CRM，并被随机分为1：1在12个月时接受MenACWY-CRM和12个月时仅接受MMRV治疗。使用预定义的非劣势标准，比较接受和未接受MenACWY-CRM的患者对MMRV中抗原的免疫应答；比较接受和未接受伴随的MMRV的患者对MenACWY-CRM的免疫应答，以具有人类血清杀菌活性(HSBA)效价的受试者的百分比衡量。还评估了在7-9个月和12个月时使用两剂MenACWY-CRM的免疫应答的充分性。结果：联合应用MMRV和MenACVVY-CRM对两种疫苗的免疫应答均无影响。两剂系列的MenACWY-CRM对所有4个血清群都有足够的免疫应答。与单独接种MMRV相比，MenACWY-CRM+MMRV的反应性没有增加，也没有与研究相关的严重不良事件。结论：MenACVVY-CRM与MMRV疫苗同时接种12个月时耐受性良好，没有安全问题。对两种疫苗的所有成分都产生了强大的免疫反应，并满足了所有非劣质标准，支持在该年龄段使用两剂MenACWY-CRM方案。(C)2012爱思唯尔有限公司。保留所有权利。
Background: Invasive meningococcal disease can have devastating outcomes, especially in high-risk groups such as infants. As infants are recommended to receive multiple vaccines during a single office visit, this phase 3 study assessed the safety and immune response to MenACVVY-CRM at alternative visits in older infants and concomitant use with measles, mumps, rubella, varicella vaccine (MMRV) at 12 months of age.Methods: Two age groups were concurrently enrolled: 7- to 9-month-old infants who received 2 doses of MenACWY-CRM at 7-9 and 12 months and were randomized 1:1 to receive MenACWY-CRM with or without MMRV at 12 months, and 12-month-old infants who received MMRV only at 12 months. Using predefined non-inferiority criteria, immune responses to the antigens in MMRV were compared between those who did and did not receive MenACWY-CRM; immune responses to MenACWY-CRM as measured by the percentage of subjects with human serum bactericidal activity (hSBA) titers >= 8, were compared between those who did and did not receive concomitant MMRV. Adequacy of the immune response to 2 doses of MenACWY-CRM administered at 7-9 and 12 months was also assessed. Local and systemic reactions, adverse events resulting in withdrawal or requiring medical attention and serious adverse events were monitored.Results: Concomitant administration of MMRV with MenACVVY-CRM did not affect the immune response to either vaccine. The 2-dose series of MenACWY-CRM induced adequate immune response to all 4 serogroups. No increased reactogenicity was observed with MenACWY-CRM + MMRV compared with MMRV alone, and there were no study-related serious adverse events.Conclusions: Concomitant administration of MenACVVY-CRM with MMRV vaccinations at 12 months was well-tolerated, without safety concerns. Robust immune responses to all components of both vaccines were produced and all criteria for non-inferiority were met, supporting the use of a 2-dose regimen of MenACWY-CRM in this age group. (C) 2012 Elsevier Ltd. All rights reserved.