drugset / Trial / NCT05408312
Phase I Clinical Trial of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above
Phase 1
Completed
234 enrolled
National Vaccine and Serum Institute, China
Beijing Institute of Biological Products Co Ltd. · collabLanzhou Institute of Biological Products Co., Ltd · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
phase I study will evaluate the safety and tolerability of GEN2-Recombinant COVID-19 Vaccine (CHO cells) in healthy people aged 18 years and older. A total of 234 subjects were enrolled, of which 126 were enrolled in the 18-59-year-old group, and were randomly assigned to receive experimental vaccine 1, experimental vaccine 2, experimental vaccine 3 and placebo in a ratio of 2:2:2:1; 60- A total of 54 people were enrolled in the 69-year-old and ≥70-year-old groups, and were randomly assigned to receive the experimental vaccine 1 and placebo according to the ratio of 2:1.
Timeline
- Start
- 2022-06-18
- Primary completion
- 2024-02-28
- Completion
- 2024-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NVSI-06-08 | Vaccine | — | Intramuscular |