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The purpose of this clinical study, CLO-SCB-2019-010, is to assess the immunogenicity, reactogenicity and safety of the SCB-2019 vaccine in Chinese participants, and to show the comparability of the immune response versus randomly selected individuals who participated in the large-scale efficacy study with the SCB-2019 vaccine (Study CLO-SCB-2019-003).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCB-2019 vaccine | Experimental | Investigational SCB-2019 vaccine contains 30 μg of SCB-2019 antigen, and 1.5 mg CpG 1018 and 0.75 mg Alhydrogel as adjuvants, in each 0.5 mL dose |
|
| Placebo | Placebo Comparator | Saline solution (0.9%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candidate Vaccine, SCB-2019 | Biological | 30 μg of SCB-2019 antigen, and 1.5 mg CpG 1018 and 0.75 mg Alhydrogel as adjuvants |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT ratio of GMT-CLO-SCB-2019-010 over GMT-CLO-SCB-2019-003 | To demonstrate that SCB-2019 vaccine in this study of Chinese participants elicits immune response that is non-inferior to that in a randomly selected subset of participants of the CLO-SCB-2019-003 clinical study, as measured by virus neutralization assay | Day 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Center for Disease Control and prevention | Taiyuan | Shanxi | China | |||
| Sichuan Center for disease control |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000721887 | SCB-2019 COVID-19 vaccine |
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| Placebo | Other | Saline solution (0.9%) |
|
| Chengdu |
| Sichuan |
| China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |