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 2 to 6 years. 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, as measured by serum antibody levels? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the control group (licensed ACYW135 polysaccharide vaccine) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile. Participants will: Receive a single dose of either the investigational vaccine or the control vaccine by intramuscular injection; Provide two blood samples (before vaccination and 30 days after) for antibody testing; Have their vaccination site and overall health monitored for AE/AR immediately after injection, for 7 days and for 30 days through diary card and follow-up contacts; Be followed for serious adverse events for 6 months after vaccination. A total of 660 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
660
group ACYW135 meningococcal conjugate vaccine
group ACYW135 meningococcal polysaccharide vaccine
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 vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Time frame: Day 30 after 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 vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Time frame: Day 30 after 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 vaccination in baseline seronegative participants
Time frame: Day 30 after 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 vaccination in baseline seronegative participants
Time frame: Day 30 after 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 vaccination in the overall study population
Time frame: Day 30 after 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 vaccination in the overall study population
Time frame: Day 30 after 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 vaccination in the overall study population
Time frame: Day 30 after vaccination
Proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128
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 vaccination in baseline seronegative participants and the overall study population
Time frame: Day 30 after vaccination
Incidence of adverse reactions/events
Incidence of adverse reactions/events within 30 minutes after vaccination
Time frame: Within 30 minutes after vaccination
Incidence of adverse reactions/events
Incidence of adverse reactions/events within 0\~30 days after vaccination
Time frame: 0~30 days after vaccination
Incidence of serious adverse events
Incidence of serious adverse events within six months after vaccination
Time frame: Within six months after vaccination
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