drugset / Trial / NCT07834073
Immunogenicity and Safety of a Single Dose of mRNA SARS-CoV-2 Vaccine in Chinese Adults With Hybrid Immunity
NaSingle-groupOpen-labelPrevention
Summary
This is a multicentre post-marketing cohort study to evaluate the immunogenicity and safety of a single dose of mRNA SARS-CoV-2 vaccine SYS6006 in Chinese adults predominantly with hybrid immunity. A total of 2,052 adults aged 18 years and older who received one dose of SYS6006 were monitored for serious adverse events (SAEs) for 6 months. The first 60 participants comprised an immunogenicity subgroup, with blood samples collected before vaccination and at day 14, month 3, and month 6 post-vaccination to assess humoral and cellular immune responses.
Timeline
- Start
- 2023-05-23
- Primary completion
- 2024-02-28
- Completion
- 2024-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SYS6006 | Messenger RNA (mRNA) | 30 ug | Intramuscular |