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A Cohort Study to Evaluate Safety and Immunogenicity of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine (LVRNA012) in Participants Aged 18 Years and Over in China
This is a cohort study to evaluate safety and immunogenicity of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine (LVRNA012) in participants aged 18 years and over in China
Details
| Lead sponsor | AIM Vaccine Co., Ltd. |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 350 |
| Start date | 2023-04 |
| Completion | 2024-04 |
Conditions
- SARS-CoV-2
Interventions
- SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine low dose
- SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine high dose
- Placebo
Primary outcomes
- SARS-CoV-2 Novel coronavirus S protein antibody (IgG) level — At 28 days after full immunization
- The levels of neutralizing antibodies of SARS-CoV-2 anti-Novel coronavirus 2019 (Omicron BA.2, BA.4, BA.5 and Delta strains) true virus — At 28 days after full immunization
- The levels of neutralizing antibodies of SARS-CoV-2 anti-Novel coronavirus 2019 (Omicron BA.2, BA.4, BA.5 and Delta strains) pseudovirus — At 28 days after full immunization