Adis, 41 Centorian Drive Private Bag 65901 Mairangi Bay North Shore, 0754 Auckland, New Zealand.
Drugs. 2013 May;73(7):703-13. doi: 10.1007/s40265-013-0048-9.
The meningococcal groups C and Y and Haemophilus b (Hib) tetanus toxoid conjugate vaccine (HibMenCY-TT) contains Neisseria meningitidis serogroup C and Y capsular polysaccharide antigens, and Hib capsular polysaccharide [polyribosyl-ribitol-phosphate (PRP)]. The HibMenCY-TT vaccine is available in the USA for use as active immunization to prevent invasive disease caused by N. meningitidis serogroups C (MenC) and Y (MenY), and Hib in children 6 weeks-18 months of age. HibMenCY-TT is the first meningococcal vaccine available for use in the USA that can be administered to infants as young as 6 weeks of age. In a randomized, controlled, phase III clinical trial, the HibMenCY-TT vaccine, administered to infants at 2, 4, 6 and 12-15 months of age, was immunogenic against MenC and MenY, and met the prespecified criteria for immunogenicity. Anti-PRP antibodies, which have been shown to correlate with protection against Hib invasive disease, were also induced in the infants who received the HibMenCY-TT vaccine, with induced levels of this antibody noninferior to those occurring in the control group of infants who received a Hib tetanus toxoid conjugate vaccine at 2, 4, and 6 months and a single dose of Hib conjugated to N. meningitidis outer membrane protein at 12-15 months. In several randomized, controlled clinical trials, HibMenCY-TT was coadministered with vaccines that are routinely administered to infants and toddlers in the USA. These vaccines included: diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined; 7-valent Streptococcus pneumoniae polysaccharide conjugate vaccine; measles, mumps and rubella vaccine; and varicella vaccine. Coadministration of these vaccines did not interfere with the immunogenicity of the HibMenCY-TT vaccine. Similarly, immune responses to the coadministered vaccines were not affected by the HibMenCY-TT vaccine. The tolerability profile of the HibMenCY-TT vaccine in infants and toddlers in the phase III trial was considered to be clinically acceptable and comparable to that of the Hib conjugate vaccines received by the control group.
脑膜炎球菌 C 群和 Y 群及乙型流感嗜血杆菌（Hib）破伤风类毒素结合疫苗（HibMenCY-TT）含有脑膜炎奈瑟菌 C 群和 Y 群荚膜多糖抗原，以及 Hib 荚膜多糖[多聚核糖醇磷酸（PRP）]。HibMenCY-TT 疫苗在美国获准用于主动免疫，预防 6 周至 18 月龄儿童侵袭性疾病，包括由脑膜炎奈瑟菌 C 群（MenC）和 Y 群（MenY）以及 Hib 引起的疾病。HibMenCY-TT 是美国首个可用于 6 周龄婴儿的脑膜炎球菌疫苗。在一项随机、对照、III 期临床试验中，2、4、6 和 12-15 月龄时接种 HibMenCY-TT 疫苗的婴儿对 MenC 和 MenY 具有免疫原性，且符合免疫原性预设标准。在接种 HibMenCY-TT 疫苗的婴儿中，抗 PRP 抗体也被诱导产生，该抗体的诱导水平与对照组中接种 Hib 破伤风类毒素结合疫苗 2、4 和 6 月龄以及在 12-15 月龄时接种 Hib 与脑膜炎奈瑟菌外膜蛋白结合的单价疫苗的婴儿所产生的抗体相当。在几项随机、对照临床试验中，HibMenCY-TT 与美国常规用于婴儿和幼儿的疫苗联合使用。这些疫苗包括：白喉和破伤风类毒素以及无细胞百日咳吸附疫苗、乙型肝炎（重组）和灭活脊髓灰质炎病毒疫苗联合疫苗；7 价肺炎链球菌多糖结合疫苗；麻疹、腮腺炎和风疹疫苗；和水痘疫苗。这些疫苗联合使用不会干扰 HibMenCY-TT 疫苗的免疫原性。同样，联合疫苗的免疫应答也不受 HibMenCY-TT 疫苗的影响。在 III 期临床试验中，HibMenCY-TT 疫苗在婴儿和幼儿中的耐受性与对照组接受的 Hib 结合疫苗相似，被认为是临床可接受的。
