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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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A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1.
The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.
From January to April 2020, this study was affected by the COVID-19 epidemic, which caused the two groups(6-17-year-old,3-5-year-old) of subjects to vaccinate beyond the window and deviate from the experimental plan. After communication between the researcher, the sponsor and the statistician, it was decided to restart the Phase I clinical trials of these two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccine group 1 | Experimental | vaccine produced by NVSI , Specification: GI.1 / GII.4 (low), 0.5ml / dose |
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| vaccine group 2 | Experimental | vaccine produced by NVSI , Specification: GI.1 / GII.4 (middle), 0.5ml / dose |
|
| vaccine group 3 | Experimental | vaccine produced by NVSI , Specification: GI.1 / GII.4 (high), 0.5ml / dose |
|
| Normal saline | Placebo Comparator | (0.5ml / dose)produced by NVSI |
|
| Aluminum adjuvant | Placebo Comparator | (0.5ml / dose)produced by NVSI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norovirus Bivalent (GI.1 / GII.4) Vaccine(low) | Biological | Norovirus Bivalent (GI.1 / GII.4) Vaccine(low)administered intramuscularly according to a 0, 28,(56) day vaccination schedule |
| Measure | Description | Time Frame |
|---|---|---|
| AE of local and systemic reactions within 30 minutes after each dose | 30 minutes | |
| All active AEs within 0-7 days after each dose | Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination | 7 days |
| All non-active collection AEs within 0-28(30) days after each dose | Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window | 28(30) days |
| All SAEs within 6 months after the last dose is vaccinated | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies | 28 days after the full vaccination | |
| Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies | 28 days after the full vaccination |
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Inclusion Criteria:
Exclusion Criteria:
In addition to the general exclusion criteria, specific populations should also adhere to the following exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| qixian Center for Disease Control and Prevention | Hebi | Henan | China |
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| Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle) | Biological | Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle)administered intramuscularly according to a 0, 28,(56) day vaccination schedule |
|
| Norovirus Bivalent (GI.1 / GII.4) Vaccine(high) | Biological | Norovirus Bivalent (GI.1 / GII.4) Vaccine(high)administered intramuscularly according to a 0, 28,(56)day vaccination schedule |
|
| Normal saline | Biological | Normal saline administered intramuscularly according to a 0, 28 ,(56)day vaccination schedule |
|
| Aluminum adjuvant | Biological | Aluminum adjuvant administered intramuscularly according to a 0, 28,(56) day vaccination schedule |
|
| Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers | 28 days after the full vaccination |
| Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates | 28 days after the full vaccination |
| ID | Term |
|---|---|
| D017250 | Caliciviridae Infections |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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