Sanofi Pasteur, Swiftwater, PA 18370, USA.
Pediatr Infect Dis J. 2012 Nov;31(11):1173-83. doi: 10.1097/INF.0b013e318268dfe4.
Quadrivalent meningococcal conjugate vaccine (Menactra [MenACWY-D]), was licensed in the United States in 2005 to prevent meningococcal disease in adolescents and adults. The license was extended to children aged 2-10 years in 2007 and extended again in 2011 to infants aged 9 months and older based, in part, on results from 3 phase III studies presented herein.
The safety and immunogenicity of 2 doses of MenACWY-D was assessed in study-eligible children: dose 1 was administered at 9 months of age and dose 2 was administered 3 months later with or without routine childhood vaccines.
Thirty days after vaccination, protective serum bactericidal assay-human complement titers ≥1:8 for meningococcal serogroups A, C, Y and W-135 were achieved by 86-100% of children receiving 2 doses of MenACWY-D. When MenACWY-D was concomitantly administered with measles, mumps, rubella and varicella or heptavalent pneumococcal conjugate vaccine, 81-98% of participants achieved protective responses (serum bactericidal assay-human complement titers ≥1:8 for all serogroups). All seroprotection rates were >91% when the protective titer was defined as serum bactericidal assay-human complement ≥1:4. MenACWY-D did not interfere with measles, mumps, rubella or varicella vaccine responses (98-100% achieved protective titers). When heptavalent pneumococcal conjugate vaccine was given concomitantly with MenACWY-D, antipneumococcal antibody levels, although decreased, were protective for all serotypes by enzyme-linked immunosorbent assay (98-100% ≥ 0.35 μg/mL) and opsonophagocytic assay (99-100% ≥ 1:8). Adverse events were generally mild and similar across groups. Serious adverse events were uncommon.
MenACWY-D was safe and immunogenic when given in 2 doses to infants and toddlers; this vaccine can be given with other common childhood immunizations.
四价脑膜炎球菌结合疫苗（Menactra[MenACWY-D]）于 2005 年在美国获得许可，用于预防青少年和成年人的脑膜炎球菌病。该许可于 2007 年扩大到 2-10 岁的儿童，并于 2011 年再次扩大到 9 个月及以上的婴儿，部分基于本文介绍的 3 项 III 期研究的结果。
在符合条件的儿童中评估了 2 剂 MenACWY-D 的安全性和免疫原性：第 1 剂在 9 个月龄时接种，第 2 剂在 3 个月后接种，可与常规儿童疫苗同时接种或不接种。
接种后 30 天，接受 2 剂 MenACWY-D 的儿童血清杀菌试验-人补体效价≥1：8 的保护率为 86-100%，用于脑膜炎球菌血清群 A、C、Y 和 W-135。当 MenACWY-D 与麻疹、腮腺炎、风疹和水痘或 7 价肺炎球菌结合疫苗同时给药时，81-98%的参与者达到保护反应（所有血清群的血清杀菌试验-人补体效价≥1：8）。当保护效价定义为血清杀菌试验-人补体≥1：4 时，所有血清保护率均>91%。MenACWY-D 不干扰麻疹、腮腺炎、风疹或水痘疫苗的反应（98-100%达到保护效价）。当 7 价肺炎球菌结合疫苗与 MenACWY-D 同时给药时，虽然抗肺炎球菌抗体水平下降，但通过酶联免疫吸附试验（98-100%≥0.35μg/mL）和调理吞噬试验（99-100%≥1：8）对所有血清型均具有保护作用。不良事件通常是轻微的，且各组之间相似。严重不良事件并不常见。
2 剂 MenACWY-D 对婴儿和幼儿安全且具有免疫原性；这种疫苗可以与其他常见的儿童免疫接种一起使用。
