Loading clinical trials...

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

COMPLETEDPHASE1/PHASE2

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

Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy People Aged 3 Years and Older

NCT04869592•National Vaccine and Serum Institute, China

View on ClinicalTrials.gov

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.

Eligibility

Age

3 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age range: healthy people aged 3 years and and older who can provide legal identification;
•The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol;
•Inquired about medical history and physical examination, the investigator judged that the health condition is good;
•No history of SARS-CoV-2 vaccination before enrollment;
•Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;
•During the entire study follow-up period, be able and willing to complete the entire prescribed study plan.

Exclusion Criteria

•Confirmed cases of SARS-CoV-2 infection, suspected cases, asymptomatic infections, or close contacts with the above population (check "China Disease Prevention and Control Information System");
•Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
•Positive in SARS-CoV-2 IgG and IgM antibody screening;
•Have a history of SARS virus infection (self-report, on-site inquiry);
•Fever (axillary temperature is not less than 37.3℃), dry cough, fatigue, nasal, congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, or dyspnea within 14 days before vaccination;
•Before vaccination, the results of blood biochemistry, blood routine, urine routine, and coagulation function related indexes are abnormal, which exceed the reference value range, and have clinical significance abnormalities (only refers to phase I);
•Previous severe allergic reaction to vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain);
•Allergic to any component of the study vaccine (such as aluminum, histidine, etc.);
•Have a history of convulsions, epilepsy, encephalopathy, long-term alcoholism and drug abuse, thyroidectomy, infectious diseases, mental illness or family history;
•Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
+15 more criteria

Locations (1)

Ning ling Center for Disease Control and Prevention

Shangqiu, Henan, China

Key Dates

Start Date

April 25, 2021

Primary Completion Date

August 29, 2023

Completion Date

August 29, 2023

Last Updated

January 16, 2026

Enrollment

3,100

ACTUAL participants

Conditions

COVID-19

Interventions

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

BIOLOGICAL

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

BIOLOGICAL

placebo

BIOLOGICAL

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

View study

RECRUITINGNA

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Dime La VerDAD: Verify, Debunk, and Disseminate

Positron Emission Tomography (PET) Imaging of Thrombosis