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四价脑膜炎奈瑟菌血清型 A、C、W-135 和 Y 结合疫苗与麻疹-腮腺炎-风疹-水痘疫苗联合使用时在生命的第二年具有良好的耐受性和免疫原性:一项开放、随机对照试验。

Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial.

机构信息

Vaccine Research Center, University of Tampere Medical School, Tampere, Finland.

出版信息

Vaccine. 2011 Jun 6;29(25):4274-84. doi: 10.1016/j.vaccine.2011.03.043. Epub 2011 Apr 6.

DOI:10.1016/j.vaccine.2011.03.043
PMID:21443965
Abstract

Co-administration of meningococcal ACWY-tetanus toxoid conjugate vaccine (ACWY-TT) with MMRV vaccine was investigated in 1000 12-23-month old children randomized (3:3:1:1) to receive co-administered ACWY-TT+MMRV, or a single dose of ACWY-TT, MMRV or MenC-CRM(197). Non-inferiority of ACWY-TT to MenC-CRM(197) and non-inferiority of ACWY-TT+MMRV to ACWY-TT and MMRV alone, and the immunogenicity of serogroups AWY were demonstrated according to pre-defined criteria. Fever reactions in ACWY+MMRV and MMRV groups were comparable. ACWY-TT can be co-administered with MMRV without affecting immunogenicity or safety profiles of either vaccine. This study has been registered at www.clinicaltrials.gov NCT00474266.

摘要

将脑膜炎球菌 A、C、W、Y 四价结合型-破伤风类毒素疫苗(ACWY-TT)与 MMRV 疫苗联合使用,在 1000 名 12-23 月龄儿童中进行了研究,这些儿童被随机分为(3:3:1:1)组,分别接受联合接种 ACWY-TT+MMRV、单次接种 ACWY-TT、MMRV 或 MenC-CRM(197)。根据预设标准,证明了 ACWY-TT 对 MenC-CRM(197)的非劣效性和 ACWY-TT+MMRV 对 ACWY-TT 和 MMRV 单独接种的非劣效性,以及 A、C、W、Y 四价血清型的免疫原性。在 ACWY+MMRV 和 MMRV 组中,发热反应相当。ACWY-TT 可与 MMRV 联合使用,而不会影响两种疫苗的免疫原性或安全性。本研究已在 www.clinicaltrials.gov 注册,编号为 NCT00474266。

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