Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A single-center and open-labeled Phase I study, designed to evaluate the safety by observing the occurrence of adverse events and change of hematology, liver and renal function after vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy population aged 2 months to 55 years old.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18~55 yrs | Experimental | 1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0. |
|
| 2~17 yrs | Experimental | 1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0. |
|
| 7~23 mos | Experimental | 2 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between the first and second dose. |
|
| 3 mos | Experimental | 3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between every two doses. |
|
| 2 mos | Experimental | 3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. Two-month interval between every two doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Group ACYW135 Conjugate Vaccine | Biological | 1 dose in Stage 1 (2~55 yrs), 2 doses in Stage 2 (7~23 mos), and 3 doses in Stage 3 (2&3 mos) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events after each vaccination | Percentage of subjects with local and systemic adverse events after each dose of vaccination | 30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events after vaccination | Percentage of subjects with serious adverse events from day 0 to 6 months after last dose | day 0 to 6 months after last dose |
| Blood routine in 2 years and above subjects |
Not provided
Inclusion Criteria:
Exclusion Criteria for First Dose:
Exclusion Criteria for Second and Third Dose:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Center for Disease Control and Prevention | Guangzhou | Guangdong | China |
Not provided
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
content of hemoglobin(g/dL)、white blood cell count(WBC)、blood platelet count(PLT)3 days after vaccination in 2 years and above subjects
| 3 days after vaccination |
| Liver function in 2 years and above subjects | Alanine aminotransferase(ALT),Aspartate aminotransferase(AST),Total bilirubin(TBIL) 3 days after vaccination in 2 years and above subjects | 3 days after vaccination |
| Renal function in 2 years and above subjects | Creatinine(CR),Urea nitrogen(BUN)3 days after vaccination in 2 years and above subjects | 3 days after vaccination |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |