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A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of LIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and BIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) in Healthy Population Aged 18 and Above
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.
Details
| Lead sponsor | National Vaccine and Serum Institute, China |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 16000 |
| Start date | 2022-11-04 |
| Completion | 2023-12 |
Conditions
- COVID-19
- Coronavirus Infections
Interventions
- LIBP-Rec-Vaccine
- BIBP-Rec-Vaccine
- placebo
Primary outcomes
- Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above. — 14th day after vaccination
Rates of cohort 1 subjects not infected with COVID-19
Countries
United Arab Emirates