Kaiser Permanente Vaccine Center, Oakland, CA 94612, USA.
Vaccine. 2012 Jun 6;30(26):3929-36. doi: 10.1016/j.vaccine.2012.03.080. Epub 2012 Apr 10.
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 MenACWY-CRM at alternative visits in older infants and concomitant use with measles, mumps, rubella, varicella vaccine (MMRV) at 12 months of age.
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.
Concomitant administration of MMRV with MenACWY-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.
Concomitant administration of MenACWY-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.
侵袭性脑膜炎球菌病可能导致严重后果，尤其是在婴儿等高危人群中。由于建议婴儿在单次就诊时接种多种疫苗，因此这项 3 期研究评估了在年龄较大的婴儿中替代访视时接种 MenACWY-CRM 的安全性和免疫应答，以及在 12 个月时与麻疹、腮腺炎、风疹、水痘疫苗（MMRV）同时使用的安全性和免疫应答。
同时纳入了两个年龄组：7-9 月龄婴儿接种 2 剂 MenACWY-CRM，分别在 7-9 月龄和 12 月龄时接种，并按 1:1 随机分配在 12 月龄时接种 MenACWY-CRM 联合或不联合 MMRV，12 月龄婴儿仅在 12 月龄时接种 MMRV。使用预先设定的非劣效性标准，比较了接受和不接受 MenACWY-CRM 的婴儿对 MMRV 抗原的免疫应答；通过人类血清杀菌活性（hSBA）滴度≥8 的受试者百分比来比较接受和不接受同时接种 MMRV 的婴儿对 MenACWY-CRM 的免疫应答。还评估了在 7-9 月龄和 12 月龄接种 2 剂 MenACWY-CRM 的免疫应答是否充分。监测局部和全身反应、导致退出或需要医疗关注的不良事件以及严重不良事件。
同时接种 MMRV 和 MenACWY-CRM 不影响对任何一种疫苗的免疫应答。MenACWY-CRM 两剂系列可诱导对所有 4 个血清群的充分免疫应答。与单独接种 MMRV 相比，接种 MenACWY-CRM+MMRV 没有观察到更高的反应原性，也没有与研究相关的严重不良事件。
在 12 个月时同时接种 MMRV 和 MenACWY-CRM 疫苗耐受性良好，无安全性问题。两种疫苗的所有成分均产生了强大的免疫应答，所有非劣效性标准均得到满足，支持在该年龄组使用 MenACWY-CRM 两剂方案。
