This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
840
Jiangjin District Center for Disease Control and Prevention
Chongqing, China
Wanzhou District Center for Disease Control and Prevention
Chongqing, China
Yuzhong District Center for Disease Control and Prevention
Chongqing, China
Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects
Time frame: 30 days post immunization
Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects
Time frame: 30 days post immunization
Incidence of adverse reactions in all subjects
Time frame: Within 30 mins after immunization
Incidence of adverse reactions/events in all subjects
Time frame: 7 days post immunization
Incidence of adverse reactions/events in all subjects
Time frame: Within 30 days after immunization
Meningococcal antibody positivity for groups A, C, Y, and W135
Time frame: 30 days post immunization
Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135
Time frame: 30 days post immunization
Antibody titer ≥1:128 ratio for groups A, C, Y, and W135
Time frame: 30 days post immunization
Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects
Time frame: 180 days after immunization
GMT for groups A, C, Y, and W135 in selected subjects
Time frame: 180 days after immunization
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GMI for groups A, C, Y, and W135 in selected subjects
Time frame: 180 days after immunization
Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 in selected subjects
Time frame: 180 days after immunization
Incidence of serious adverse events (SAEs) in all subjects
Time frame: Within 180 days after immunization
Incidence of pregnancy events in all subjects
Time frame: Within 180 days after immunization