The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months. The main questions it aims to answer are: Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the active comparator group (licensed ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO; hereinafter referred to as CanSinoBIO MCV-ACYW) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile. Participants will: Receive two doses of either the investigational vaccine or the control vaccine according to a 0,1-month schedule; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after completion of the primary immunization series; A total of 1040 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,040
Group ACYW135 Meningococcal Conjugate Vaccine
Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)
seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135
seroconversion rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Time frame: Day 30 after two-dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Time frame: Day 30 after two-dose vaccination
seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in baseline seronegative participants
Time frame: Day 30 after two-dose vaccination
GMIs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in baseline seronegative participants
Time frame: Day 30 after two-dose vaccination
seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
seroconversion rates and seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in the overall study population
Time frame: Day 30 after two-dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in the overall study population
Time frame: Day 30 after two-dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in the overall study population
Time frame: Day 30 after two-dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135 at Day 30 after two-dose vaccination in baseline seronegative participants and the overall study population
Time frame: Day 30 after two-dose vaccination
incidence of adverse reactions/events
incidence of adverse reactions/events within 30 minutes after each dose vaccination
Time frame: within 30 minutes after each dose vaccination
incidence of adverse reactions/events
incidence of adverse reactions/events within 0\~30 days after each dose vaccination
Time frame: within 0~30 days after each dose vaccination
incidence of serious adverse events
incidence of serious adverse events from the first dose to six months after the second dose
Time frame: from the first dose to six months after the second dose
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