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

NCT05398848 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7623

Last updated 2024-02-29

No results posted yet for this study

Summary

This is a multicenter designed Phase III clinical trial. About 10000 participants plan to be enrolled.The objectives of this study are to evaluate the efficacy, safety and immunogenicity of the recombinant two-component COVID-19 vaccine (CHO cell) in adults

Conditions

Interventions

BIOLOGICAL

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

Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter

BIOLOGICAL

Placebo

Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter

Sponsors & Collaborators

  • Jiangsu Rec-Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-09-04
Completion
2023-12-29

Countries

  • Nepal
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05398848 on ClinicalTrials.gov