drugset / Trial / NCT05933512
A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.
Timeline
- Start
- 2023-08-10
- Primary completion
- 2023-12-10
- Completion
- 2024-11-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | SCTV01E | Vaccine | — | Intramuscular |
| Subject | SCTV01E-2 | Vaccine | — | Intramuscular |