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| Name | Class |
|---|---|
| Lanzhou Institute of Biological Products Co., Ltd | INDUSTRY |
| Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd. | UNKNOWN |
| Zhengzhou University | OTHER |
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Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18-59 years old group A | Experimental |
| |
| 18-59 years old group B | Experimental |
| |
| 18-59 years old group C | Placebo Comparator |
| |
| 6-17 years old group A | Experimental |
| |
| 6-17 years old group B | Experimental |
| |
| 6-17 years old group C | Placebo Comparator |
| |
| 3-5 years old group A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine | Biological | Intramuscular injection of middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination | through 30 minutes after each dose | |
| the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination | through 7 days after each dose | |
| the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination | If there is still next vaccination ,collect the incidence and severity of non-collective adverse reactions/events within vaccination interval(28 days) after vaccination | through 30 days after each dose |
| the incidence of SAE from the first dose of vaccination to 6 months after the full course of vaccination | up to 6 months after the full course of vaccination | |
| Antibody titer of HBGA-blocking antibody on the 14th day after the full course of vaccination | 14th day after the full course of vaccination | |
| 4-fold Seroconversion rate on the 14th day after the full course of vaccination | 14th day after the full course of vaccination | |
| Antibody titer of(NoV GI.1 and GII.4 HBGA-blocking antibody)on the 14th day after the full course of vaccination | 14th day after the full course of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean Titer of(NoV GI.1 and GII.4 HBGA-blocking antibody)on the 14th day after the full course of vaccination | 14th day after the full course of vaccination | |
| Immune response(compared with before vaccination, the antibody increased by 4 times or more) rate of(NoV GI.1 and GII.4 HBGA-blocking antibody)on the 14th day after the full course of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
First Dose Exclusion Criteria:
In addition to the general exclusion criteria, specific populations should also follow the following exclusion criteria:
-Children aged 24 months and under are born prematurely (delivered before the 37th week of pregnancy), low-weight (birth weight for girls <2300g, boys <2500g) infants; Children 24 months of age and younger have a history of dystocia, birth asphyxia or other reasons, a history of neurological damage, severe chronic diseases (such as Down syndrome, sickle cell anemia, or neurological disorders).
Subsequent doses of vaccination Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia shengli, bachelor | Contact | (+86)13592610137 | 1792865518@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| qixian Center for Disease Control and Prevention | Recruiting | Hebi | Henan | China |
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| 3-5 years old group B | Experimental |
|
| 3-5 years old group C | Placebo Comparator |
|
| 6-35 months old group A | Experimental |
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| 6-35 months old group B | Experimental |
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| 6-35 months old group C | Placebo Comparator |
|
| 6-35 months old group D | Experimental |
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| 6-35 months old group E | Experimental |
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| 6-35 months old group F | Placebo Comparator |
|
| high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine | Biological | Intramuscular injection of high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm |
|
| placebo | Biological | Intramuscular injection of placebo in the deltoid muscle of the upper arm |
|
| 14th day after the full course of vaccination |
| Antibody titer of(NoV GI.1 and GII.4 HBGA-blocking antibody)on 90th,180th,270th,360th,540th,720th day after the full course of vaccination | 90th,180th,270th,360th,540th,720th day after the full course of vaccination |
| Binding Antibody (IgG) on 90th,180th,270th,360th,540th,720th day after the full course of vaccination | 90th,180th,270th,360th,540th,720th day after the full course of vaccination |
| ID | Term |
|---|---|
| D017250 | Caliciviridae Infections |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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