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| ID | Type | Description | Link |
|---|---|---|---|
| 2013L01041 | Registry Identifier | China food and drug administration |
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The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCV-ACYW135 Vaccine Group | Experimental | Participants at age 2 to 6 years of enrollment will receive 1 dose on Meningococcal ( A, C, Y and W 135) conjugate vaccine. Participants at age 6 to 23 months of enrollment will receive 2 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 3 months apart. Participants at age 3 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 1 month apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 2 months apart. |
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| MPV-ACYW135 Vaccine Group | Active Comparator | Participants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine |
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| MPV-A Vaccine Group | Active Comparator | Participants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart. |
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| MCV-AC Vaccine Group | Active Comparator | Participants at age 3 to 5 months of enrollment will receive 3 doses on Group A and C Meningococcal conjugate vaccine at 1 month apart. |
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| Hib Vaccine Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCV-ACYW135 Vaccine Group | Biological | 0.5ml, intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination | 28 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the adverse reactions after vaccination | Within 28 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| shengli xia | Henan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial Center for Disease Control and Prevention | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018074 | Vaccines, Conjugate |
| C410218 | serogroup C meningococcal conjugate vaccine |
| ID | Term |
|---|---|
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo Comparator |
Participants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart. |
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| MPV-ACYW135 Vaccine Group | Biological | 0.5ml, intramuscular |
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| MPV-A Vaccine Group | Biological | 0.5ml, intramuscular |
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| MCV-AC Vaccine Group | Biological | 0.5ml, intramuscular |
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| Hib Vaccine Group | Biological | 0.5ml, intramuscular |
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| D000941 |
| Antigens |
| D001685 | Biological Factors |