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A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5 | Clinical Trials | Clareo Health

UNKNOWNEARLY_PHASE1

A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5

A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine

NCT05585567•Livzon Pharmaceutical Group Inc.

View on ClinicalTrials.gov

Summary

It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.

Eligibility

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Adults aged 18 -59 years old at time of consent, male or female;
•Normal body temperature;
•Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
•Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
•Be able and willing to complete the study during the entire study and follow-up period;
•Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria

•Serious chronic diseases or uncontrolled diseases;
•Uncontrolled neurological disorders, epilepsy;
•Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
•Patients with congenital or acquired immunodeficiency;
•History of severe allergy or be allergic to any components of the test vaccines;
•History of hereditary hemorrhagic tendency or coagulation dysfunction;
•Patients with malignant tumors and other patients have a life expectancy less than 1 year;
•Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
•History of previous COVID-19 infection;
•Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
+2 more criteria

Locations (1)

Shaoguan Hospital of Chinese Medicine

Shaoguan, Guangdong, China

Key Dates

Start Date

September 16, 2022

Primary Completion Date

October 14, 2022

Completion Date

September 11, 2023

Last Updated

November 7, 2022

Enrollment

ACTUAL participants

Conditions

COVID-19 Pandemic

Interventions

V-01/V-01-B5

BIOLOGICAL

V-01-351/V-01-B5

BIOLOGICAL

V-01

BIOLOGICAL

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COVID-19 PneumoniaCOVID-19 Pandemic+1 more

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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: November 7, 2022Data 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.

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A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5

Inclusion Criteria

Exclusion Criteria

Corona Virus Disease 2019 Cohort Study

Long COVID and Its Associations With Health Outcomes in Older Adults

Reducing COVID-19 Vaccine Hesitancy Among Hispanic Parents

Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences

Hormonal Contributors to COVID-19 Infection (COV-ENDO)

COVID-19, Patients' Evolution and the Influence of the Pandemic on Health Care and Outcomes in Chronic Diseases