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The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous membranes of the human nasopharynx or causes local infection and can cross the mucosal barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can often cause serious disease epidemics worldwide, the main clinical features of its infection are fever, rash and meningitis, the most common clinical manifestation is acute bacterial meningitis.
The preventive measures for influenza are based on strengthening personal protection, vaccination, strengthening surveillance, early detection of patients, and active isolation and treatment. The immune response to meningococcal polysaccharide vaccine is weak in infants under 2 years of age, and only a transient immune response is produced. Numerous experiments have shown that the immunogenicity of polysaccharides is enhanced by binding to protein carriers, and a significant booster effect is produced. Meningococcal polysaccharide conjugate vaccine induces a good immune response in infants and children under 2 years of age and produces immune memory, which enhances the immune effect of the vaccine and can eliminate the carrier state of infected patients.
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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 (MSPV4) | Active Comparator | Subcutaneous injection, 0.5ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCV4 | Biological | 1 dose of MCV4 on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMT) of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization | 30 days after immunization | |
| Positive conversion rates of meningococcal antibodies to groups A, C, Y and W135 in all subjects 30 days after immunization | 30 days after immunization | |
| Incidence of adverse reactions within 30 minutes after immunization in all subjects | Within 30 minutes after immunization | |
| Incidence of adverse reactions/events within 7 days of immunization for all subjects | Within 7 days after immunization | |
| Incidence of adverse reactions/events within 30 days of exemption for all subjects | Within 30 days of exemption |
| Measure | Description | Time Frame |
|---|---|---|
| Meningococcal positivity for groups A, C, Y, and W135 for all subjects 30 days after immunization | 30 days after immunization | |
| Geometric mean growth multiplier (GMI) for all subjects 30 days after immunization | 30 days after immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanyang County Center for Disease Prevention and Control | Shanyang | Shaanxi | China |
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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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| MSPV4 | Biological | 1 dose of MSPV4 on Day 0 |
|
| Antibody titers ≥1:128 ratio for all subjects 30 days after immunization | 30 days after immunization |
| Meningococcal antibody positivity for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects | 90 and 180 days of exemption |
| GMT for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects | 90 and 180 days of exemption |
| GMI for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects | 90 and 180 days of exemption |
| Antibody titers ≥1:128 ratio for groups A, C, Y and W135 at 90 and 180 days of exemption in 500 subjects | 90 and 180 days of exemption |
| Incidence of serious adverse events (SAEs) within 180 days of exemption in all subjects | Within 180 days of exemption |
| All subjects were stratified into susceptible (<1:8) and non-susceptible (≥1:8) populations according to the 1:8 pre-immune antibody titer threshold | 30 days after immunization |
| 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 |