Instituto de Atención Pediatrica, Apdo 607-1150 La Uruca, San Jose, Costa Rica.
Wee Care Pediatrics, 2084N 1700W Suite A, Layton, UT, United States.
Vaccine. 2014 Feb 12;32(8):965-72. doi: 10.1016/j.vaccine.2013.12.034. Epub 2014 Jan 4.
The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants.
Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%).
A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups.
In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone.
侵袭性脑膜炎球菌病（IMD）的最高风险发生在<1 岁的婴儿中。四价脑膜炎球菌结合疫苗有可能预防 A、C、W 和 Y 血清群引起的 IMD。这项 3b 期、多国、开放性、随机、平行组、多中心研究评估了四价脑膜炎球菌结合疫苗 MenACWY-CRM 的 4 剂系列的安全性，该疫苗与常规疫苗同时用于健康婴儿。
2 个月大的婴儿以 3:1 的比例随机接受 MenACWY-CRM 与常规疫苗联合接种，或仅接受常规疫苗，分别在 2、4、6 和 12 个月龄时接种。从所有受试者入组到 18 个月龄时，收集了需要医疗处理的不良事件（AE）和严重不良事件（SAE）。在亚组中，在接种后 7 天内还收集了详细的安全性数据（局部和全身应征反应以及所有 AE）。主要目标是比较 MenACWY-CRM 加常规疫苗接种组与单独常规疫苗接种组在任何一次接种后第 1-7 天期间出现≥1 例严重全身反应的受试者比例（标准：组间差异的 95%置信区间上限[CI]＜6%）。
共有 7744 名受试者被随机分组，其中 1898 名在详细安全性组中。MenACWY-CRM 加常规疫苗组的严重全身反应发生率为 16%，常规疫苗组为 13%（组间差异为 3.0%[95%CI-0.8，6.4%]）。尽管未达到非劣效性标准，但在控制了显著的中心和组间差异的事后分析中，MenACWY-CRM 加常规疫苗接种与单独常规疫苗接种相当（组间差异-0.1%[95%CI-4.9%，4.7%]）。各组的应征 AEs、需要医疗处理的 AEs 和 SAE 发生率相似。
在一项大型多国安全性研究中，与单独使用常规疫苗相比，与常规疫苗同时接种的 4 剂系列 MenACWY-CRM 具有可接受的临床安全性和相似的安全性特征。
