drugset / Trial / NCT05599516
Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial
Phase 3
Unknown
16000 enrolled
National Vaccine and Serum Institute, China
Beijing Institute of Biological Products Co Ltd. · collabChina National Biotec Group Company Limited · collabLanzhou Institute of Biological Products Co., Ltd · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This clinical trial adopts a randomized, double-blind and placebo-controlled design. A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm. Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.
Timeline
- Start
- 2022-11-04
- Primary completion
- 2023-10
- Completion
- 2023-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIBP-Rec-Vaccine | Unknown | — | Intramuscular |
| Subject | LIBP-Rec-Vaccine | Unknown | — | Intramuscular |