NCT05599516

Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16,000 (estimated)
• Sponsor: National Vaccine and Serum Institute, China · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• Coronavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	LIBP-Rec-Vaccine	Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm
BIOLOGICAL	BIBP-Rec-Vaccine	Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm
BIOLOGICAL	placebo	Intramuscular injection of placebo in the deltoid muscle of the upper arm

Timeline

• Start date: 2022-11-04
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2022-10-31
• Last updated: 2022-11-10

Locations

1 site across 1 country: United Arab Emirates