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| Name | Class |
|---|---|
| Guangdong Center for Disease Prevention and Control | OTHER_GOV |
| Guizhou Center for Disease Control and Prevention | OTHER |
| National Institutes for Food and Drug Control, China | OTHER |
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To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.
Primary objective:
Secondary objective:
•To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant-Free MenAC-Hib Conjugate Vaccine Group | Experimental | Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine. |
|
| Adjuvant MenAC-Hib Conjugate Vaccine Group | Active Comparator | Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free) | Biological | 30μg /dose, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine | Day 30 post-vaccination | |
| Occurrence of adverse events during a 30 day follow-up period after each vaccination | 30 day after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of severe adverse events within six months post-vaccination | six months post-vaccination | |
| Geometric mean titer (GMT)of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeng peiyu, Bachelor | Contact | 86-668-6578613 | gzcdc6578613@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Du lin, Master | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaozhou Center for Disease Control and Prevention | Recruiting | Gaozhou | Guangdong | 525200 | China |
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| Air Force Military Medical University, China | OTHER |
| Simoon Record Pharma Information Consulting Co., Ltd. | INDUSTRY |
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|
| Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant) | Biological | 0.5ml /dose, Intramuscular |
|
|
| Day 30 post-vaccination |
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D008585 | Meningitis, Meningococcal |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C061963 | HibTITER protein, Haemophilus influenzae |
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