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This is a randomized, blinded, 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, afterwards some subjects entered the immune persistence group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197)(MCV4) | Experimental |
| |
| ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCV4 | Biological | 1 dose of MCV4 on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects | 30 Days After Immunization | |
| Geometric Mean Titer (GMT) for Groups A, C, Y, and W135 in All Subjects | 30 Days after immunization | |
| Incidence of adverse reactions in all subjects | Within 30 mins after immunization | |
| Incidence of adverse reactions/events in all subjects | Within 7 days after immunization | |
| Incidence of adverse reactions/events in all subjects | Within 30 days after immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal antibody positivity for groups A, C, Y, and W135 | 30 days after immunization | |
| Geometric mean multiplicity of increase (GMI) for groups A, C, Y, and W135 | 30 days after immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiqiang Xie | Henan Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dengfeng Center for Disease Control and Prevention | Dengfeng | China | ||||
| Kaifeng Center for Disease Control and Prevention |
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| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| MPSV4 | Biological | 1 dose of MPSV4 on Day0 |
|
| Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 | 30 days after immunization |
| Meningococcal Antibody Positivity for Groups A, C, Y, and W135 in Selected Subjects | 180 days after immunization |
| GMT for Groups A, C, Y, and W135 in Selected Subjects | 180 days after immunization |
| GMI for Groups A, C, Y, and W135 in Selected Subjects | 180 days after immunization |
| Antibody Titer ≥1:128 Ratio for Groups A, C, Y, and W135 in Selected Subjects | 180 days after immunization |
| Incidence of Serious Adverse Events (SAEs) for all subjects | Within 180 days after immunization |
| Kaifeng |
| China |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |