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This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4) | Experimental | Intramuscular injection, 0.5ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCV4 | Biological | 4 doses of vaccine on Day 0, Day30, Day 60 and Month 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of localized adverse reactions in subjects | Within 7 days after each dose of vaccination | |
| Incidence of systemic adverse reactions in subjects | Within 7 days after each dose of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions in subjects | Within 30 days after each dose of vaccination | |
| Incidence of adverse events in subjects | Within 30 days after each dose of vaccination | |
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Inclusion Criteria:
Exclusion Criteria:
First dose exclusion criteria
Subsequent dose exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Luhe District Center for Disease Control and Prevention Center for Disease Control and Prevention | Nanjing | 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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| Incidence of severe adverse events |
| Through study completion, an average of 10 months |
| 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 |