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Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial | Clinical Trials | Clareo Health

UNKNOWNPHASE3

Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of LIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and BIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) in Healthy Population Aged 18 and Above

NCT05599516•National Vaccine and Serum Institute, China

View on ClinicalTrials.gov

Summary

This clinical trial adopts a randomized, double-blind and placebo-controlled design. A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm. Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age range: healthy population aged ≥18;
•Judged by the investigator that the health condition is well after inquiry and physical examination;
•Cohort 1: participants vaccinated with ≥2 doses of inactivated COVID-19 vaccines for ≥6 months since the last dose of vaccination; Cohort 2: participants vaccinated with ≥2 doses of mRNA COVID-19 vaccines for ≥6 months since the last dose of vaccination;
•Be able and willing to complete all prescribed study schedules during the whole study period;
•The participant himself/herself is able and willing to understand study procedures, sign the informed consent form voluntarily after informed consent and comply to requirements of the study protocol.

Exclusion Criteria

•Symptomatic and suspected COVID 19 infection positive ;
•Urine pregnancy test is positive; Women of childbearing age who have positive urine pregnancy test, who are pregnant, lactating, or women who have planned pregnancy within 6 months;
•Auxiliary temperature before vaccination is ≥37.3℃ (tympanic/forehead temperature ≥37.8℃);
•Previous allergy history of vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain, etc.) or allergy to known components of COVID-19 vaccine;
•Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
•With known immunological impairment or compromised immunological function diagnosed by the hospital;
•Received whole blood, plasma and immunoglobulin therapy within 1 month;
•Known or suspected of suffering from the following diseases: acute or chronic active respiratory diseases, severe cardiovascular diseases \[cardiopulmonary failure, hypertension uncontrollable by drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg)\], acute infection, active phase of chronic disease, liver and kidney diseases, severe diabetes, malignant tumor, infectious skin diseases or severe skin allergy, HIV infection, etc. (Examination report can be provided)
•Received live attenuated vaccine within one month before vaccination;
•Received inactivated vaccine within 14 days before vaccination;
+1 more criteria

Locations (1)

Sheikh Khalifa Medical City

SEHA, Abu Dhab, United Arab Emirates

Key Dates

Start Date

November 4, 2022

Primary Completion Date

October 1, 2023

Completion Date

December 1, 2023

Last Updated

November 10, 2022

Enrollment

16,000

ESTIMATED participants

Conditions

COVID-19Coronavirus Infections

Interventions

LIBP-Rec-Vaccine

BIOLOGICAL

BIBP-Rec-Vaccine

BIOLOGICAL

placebo

BIOLOGICAL

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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 10, 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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Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial

Inclusion Criteria

Exclusion Criteria

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