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This is a phase 2, randomized, observer-blinded, placebo-controlled clinical study to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (SYS6006)in healthy participants aged 18 or more.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 μg dose of SYS6006 (Aged 18~59 years or 60 years or more) | Experimental | 20μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
|
| 30 μg dose of SYS6006 (Aged 18~59 years or 60 years or more) | Experimental | 30 μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
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| Placebo(Aged 18~59 years or 60 years or more) | Placebo Comparator | placebo IM, on day 0 and day 21 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYS6006 20 μg | Biological | SARS-CoV-2 mRNA Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody | 14 days after the second dose | |
| Adverse events (AEs), including solicited AEs and unsolicited AEs | From the first dose through 30 days following the second dose | |
| AEs associated with the study intervention | From the first dose through 30 days following the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events (SAEs) | from the first dose through 12 months after the second dose. | |
| Adverse events of special interest (AESIs) | rom the first dose through 12 months after the second dose. |
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Inclusion Criteria:
Exclusion Criteria:
Those who meet any of the following criteria must be excluded from this study:
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| Name | Affiliation | Role |
|---|---|---|
| Yuliang Zhao | Center For Disease Control and Prevention, Hebei Province | Principal Investigator |
| Jingxin Li | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Xiang Lu | Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Provincial Center For Disease Control and Prevention | Shijiazhuang | Hebei | 050024 | China | ||
| Sir Run Run Hosipital Nanjing Medical University |
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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 |
|---|---|
| C000722716 | SYS6006 COVID-19 vaccine |
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| SYS6006 30 μg | Biological | SARS-CoV-2 mRNA Vaccine |
|
| Placebo | Biological | Placebo |
|
| Laboratory test related adverse events | 4 days following each dose. |
| Geometric Mean Titer(GMT), Geometric Mean Fold Increase (GMI) and Seroconversion Rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody | from the first dose through 21 days |
| GMT, GMI and SCR of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody | 30, 90, 180 and 360 days after the second dose. |
| Nanjing |
| Jiangsu |
| China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |