[Translation] An open-label, age-decreasing safety and immunogenicity phase I study of an investigational quadrivalent meningococcal conjugate vaccine in healthy adolescents, children, toddlers, and infants in China
主要目的:(安全性)描述 MenACYW 结合疫苗与对照疫苗(即本地已获批的 A群C群脑膜炎球菌多糖结合疫苗:罗益或绿竹)的安全性特征。次要目的:1. 队列I:给予单剂疫苗后对相应A、C、Y 和 W 血清群脑膜炎球菌以及A 和 C 血清群脑膜炎球菌的抗体应答。2. 队列 II:给予单剂疫苗后对相应A、C、Y 和 W 血清群脑膜炎球菌以及A 和 C 血清群脑膜炎球菌的抗体应答3. 队列 III:给予单剂疫苗后对相应A、C、Y 和 W 血清群脑膜炎球菌以及A 和 C 血清群脑膜炎球菌的抗体应答4. 队列 IV:给予2剂疫苗后对相应A、C、Y 和 W 血清群脑膜炎球菌以及A 和 C 血清群脑膜炎球菌的抗体应答5. 队列 V:给予3剂疫苗后对相应A、C、Y 和 W 血清群脑膜炎球菌以及A 和 C血清群脑膜炎球菌的抗体应答6. 描述在接种前以及接种第 1、2 或 3 剂次相应研究疫苗(MenACYW结合疫苗和对照疫苗)后 30 天,对相应A、C、Y和 W 血清群脑膜炎球菌的免疫原性
[Translation] Main objective: (Safety) To describe the safety profile of the MenACYW conjugate vaccine and a control vaccine (i.e. locally approved Group A and Group C meningococcal polysaccharide conjugate vaccine: Luoyi or Luzhu). Secondary objectives: 1. Cohort I: Antibody responses to meningococci of serogroups A, C, Y, and W, as well as serogroups A and C, respectively, following administration of a single dose of vaccine. 2. Cohort II: Antibody responses to meningococci of the corresponding serogroups A, C, Y, and W and serogroups A and C after a single dose of the vaccine 3. Cohort III: Antibody responses to the corresponding A, C, Y, and W meningococci after a single dose Antibody responses to meningococci of serogroups C, Y, and W as well as meningococci of serogroups A and C Antibody responses to serogroup meningococci 5. Cohort V: Antibody responses to serogroup A, C, Y, and W meningococci, corresponding to serogroups A and C, after 3 doses of vaccine 6. Described before vaccination and immunogenicity against meningococci of the corresponding serogroups A, C, Y and W 30 days after administration of the 1st, 2nd or 3rd dose of the corresponding study vaccine (MenACYW conjugate vaccine and control vaccine)