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The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).
Meningococci are divided into 12 serogroups, and 95% of meningococcal cases are caused by serogroups A, B, C, X, W, and Y. Meningococcal epidemic flora can change, and the reasons are related to various factors such as meningococcal strain variation, human mobility transmission, and vaccination against different serogroups of meningococci, etc. The emergence of new serogroups of meningococci can cause the original vaccine to lose its immune protective efficacy and require a new vaccine immunization prevention strategy. the ACYW135 group meningococcal polysaccharide conjugate vaccine was approved in 2016 for a whole population The vaccine has been approved by the State Drug Administration for the prevention of epidemic meningoencephalitis caused by meningococci of groups A, C, W135 and Y in children from 3 months to 3 years of age (47 months of age).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part Ⅰ: Vaccine Group A | Experimental | 2 dose of ACYW135 group meningococcal polysaccharide conjugate vaccine(MCV4) (0.5ml) |
|
| PartⅠ: Vaccine Group B | Experimental | 2 dose of MCV4 (0.5ml) |
|
| Part Ⅱ: Vaccine Group C | Experimental | 1 dose of MCV4 (0.5ml) at 3 years old from group B in Part I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCV4 | Biological | 2 dose of MCV4 on Day 0 and Month 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody positivity for A, C, Y and W135 in all subjects 6 months after 2 dose exemption | 6 months after 2 dose exemption | |
| Seroconversion rates for serotypes A, C, Y, and W135 | 30 days post-booster vaccination | |
| Geometric mean titers (GMTs) for serotypes A, C, Y, and W135 | 30 days post-booster vaccination | |
| Increased incidence of adverse reactions | Within 7 days after post-booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody positivity for A, C, Y and W135 in all subjects 9 months after 2 dose exemption | 9 months after 2 dose exemption | |
| A, C, Y and W135 antibody positive conversion rate, positivity rate, GMT, GMI, ≥1:128 ratio in all subjects at 30 days after dose 2 exemption |
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Part Ⅰ
Inclusion Criteria:
Exclusion Criteria:
Part Ⅱ
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuzhi County Center for Disease Control and Prevention | Jiaozuo | Henan | 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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| MCV4 |
| Biological |
2 dose of MCV4 on Day 0 and Month 3 |
|
| MCV4 | Biological | 1 booster dose of MCV4 at 3 years old |
|
| 30 days after dose 2 exemption |
| A, C, Y and W135 antibody GMT, GMI, ≥1:128 ratio in all subjects at 6 and 9 months after 2 dose exemption | 6 and 9 months after 2 dose exemption |
| A, C, Y and W135 antibody GMT, positivity rate, GMI 30 days, 60 days after the first dose, and before the second dose in some subjects of the (0, 3) month immunization program | 30 days , 60 days after the first dose, and before the second dose |
| Increased incidence of adverse events | Within 7 days after post-booster vaccination |
| Increased Incidence of adverse reactions/events | Within 30 days after post-booster vaccination |
| A, C, Y, and W135 Antibody Positivity Rates and GMI and ≥1:128 Proportions | Within 30 days after post-booster vaccination |
| 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 |