Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)

PHASE2CompletedINTERVENTIONAL
Enrollment

948

Participants

Timeline

Start Date

January 31, 2022

Primary Completion Date

August 18, 2022

Study Completion Date

February 9, 2023

Conditions
COVID-19
Interventions
BIOLOGICAL

Part1:Recombinant two-component COVID-19 vaccine (CHO cell)

2 doses. Before reconstitution:Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: 40ug/vial; Does Volume: 0.5ml/dose Routine of administration: Intramuscular (IM) injection

BIOLOGICAL

Part1: Placebo

2 doses. Before reconstitution: Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: Not Applicable; Does Volume: 0.5ml/dose; Routine of administration: IM injection;

BIOLOGICAL

Part2: Recombinant two-component COVID-19 vaccine (CHO cell)

1 dose.Before reconstitution:Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: 40ug/vial; Does Volume: 0.5ml/dose Routine of administrati

BIOLOGICAL

Part2: COVID-19 Vaccine, mRNA

1 dose. Intramuscular injection, 30 μg/0.3 mL.

Trial Locations (1)

Unknown

The Health Centrum, Roxas City

All Listed Sponsors
lead

Jiangsu Rec-Biotechnology Co., Ltd.

INDUSTRY