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| Name | Class |
|---|---|
| Yunnan University | UNKNOWN |
| Kunming Medical University | OTHER |
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This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RQ3013 | Active Comparator | C-3013B-202211005, Alpha/Beta, mRNA 30μg dose |
|
| RQ3025 | Experimental | INDA-3025TB-20221002, Alpha/Beta + Omicron BA.2/4/5, mRNA 30μg dose |
|
| RQ3027 | Experimental | IND-3027TB-202304001, Alpha/Beta + Omicron XBB.1.5, mRNA 30μg dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RQ3013 | Biological | 0.15mL/dose containing mRNA 30μg |
| |
| RQ3025 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5 | Day 14 | |
| Number of Participants with Solicited Local and Systemic Averse Events(AEs) | Up to Day 14( 7 days after vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5 | Day 0, Day 7, Day 28, Day 90, Day 180 | |
| Number of Participants with Unsolicited Local and Systemic Averse Events(AEs) | Up to Day 180( 28 days after vaccination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Yunnan University | Kunming | Yunnan | 650091 | China |
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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 |
|---|---|
| C000722726 | RQ3013 COVID-19 vaccine |
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| Biological |
0.15mL/dose containing mRNA 30μg |
|
| RQ3027 | Biological | 0.15mL/dose containing mRNA 30μg |
|
| Number of Participants with Serious AEs(SAEs) | Up to Day 180 |
| The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4) | Day 7, Day 28, Day 90, Day 180 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |