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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4) | Experimental | Intramuscular injection, 0.5ml |
|
| ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4) | Active Comparator | Subcutaneous iniection, 0.5ml |
|
| 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 for groups A, C, Y, and W135 in all subjects | 30 days post immunization | |
| Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects | 30 days post immunization | |
| Incidence of adverse reactions in all subjects | Within 30 mins after immunization | |
| Incidence of adverse reactions/events in all subjects | 7 days post 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 post immunization | |
| Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135 | 30 days post immunization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Wang | Chongqing Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangjin District Center for Disease Control and Prevention | Chongqing | China | ||||
| Wanzhou District 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 MSPV4 on Day 0 |
|
| Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 |
| 30 days post 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) in all subjects | Within 180 days after immunization |
| Incidence of pregnancy events in all subjects | Within 180 days after immunization |
| Chongqing |
| China |
| Yuzhong District Center for Disease Control and Prevention | Chongqing | 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 |