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An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010) in Healthy Participants Aged 18 Years and Older
An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010)
Details
| Lead sponsor | AIM Vaccine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 144 |
| Start date | 2023-02 |
| Completion | 2024-05 |
Conditions
- SARS-CoV-2
Interventions
- SARS-CoV-2 variant mRNA vaccine low dose
- SARS-CoV-2 variant mRNA vaccine high dose
Primary outcomes
- Incidence, severity, and duration of each solicited (local and systemic) AE. — Within 30 minutes and 7 days after (each dose of) vaccination
- Incidence, severity, and duration of each unsolicited AE. — Within 28 days after (each dose of) vaccination
- The percentage of participants with abnormal hematology and chemistry laboratory values. — 4 days after (each dose of) vaccination