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A Clinical Trial to Evaluate the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for COVID-19

NCT04869592 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3100

Last updated 2026-01-16

No results posted yet for this study

Summary

phase I study will evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 3 years and older. 300 subjects will be enrolled and divided into 5 age groups: 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group and 3-8 years old group. In each group, there are two regimen cohort: low-dose at 0,30, 60 schedule and high-dose at 0,30,60 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1.

Phase II clinical study will explore dose and immunization procedures in 5 age groups, including 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group, and 3-8 years old group, with a total of 3280 subjects.

Conditions

Interventions

BIOLOGICAL

low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm

BIOLOGICAL

high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)

Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm

BIOLOGICAL

placebo

Intramuscular injection of placebo in the deltoid muscle of the upper arm

Sponsors & Collaborators

  • Lanzhou Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.

    collaborator UNKNOWN

  • Zhengzhou University

    collaborator OTHER

  • National Vaccine and Serum Institute, China

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-25
Primary Completion
2023-08-29
Completion
2023-08-29

Countries

  • China

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 NCT04869592 on ClinicalTrials.gov