- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510207
A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above (COVID-19)
June 15, 2023 updated by: China National Biotec Group Company Limited
Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2
doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 & D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months
Study Type
Interventional
Enrollment (Actual)
44101
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sanabis, Bahrain
- Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S
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Cairo, Egypt, 11835
- Katameya Medical Center
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Cairo, Egypt, 22311
- Vacsera health Care facilities , MoH
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Amman, Jordan
- Prince Hamza Hospital
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Abu Dhabi, United Arab Emirates, 51900
- Sheikh Khalifa Medical City, SEHA
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Sharjah, United Arab Emirates, 61545
- Al Qarain Primary Health Care Centre-MOHAP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy subjects aged 18 years old and above.
- By asking for medical history and physical examination, the investigator judged that the health condition is well.
- Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
- During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
- With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.
Exclusion Criteria:
- Confirmed acute cases of SARS-CoV-2 Infection.
- Have a history of SARS, MERS infection (self-report, on-site inquiry).
- Positive urine pregnancy test result.
- Fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
- Axillary body temperature > 37.0 ℃ before vaccination.
- Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
- Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
- With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- With severe liver diseases, severe kidney diseases defined as eGFR less than 60, uncontrollable hypertension (systolic blood pressure >150 mmHg, diastolic blood pressure > 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
- Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
- With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
- Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
- Receiving anti-TB therapy.
- Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
- Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
- Received blood products within 3 months before this vaccination
- Received other research drugs within 6 months before this vaccination.
- Other circumstances judged by investigators that are not suitable for this clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Investigational Vaccine 1
Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 & D21.
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The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
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Experimental: Investigational Vaccine 2
Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 & D21.
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The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
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Placebo Comparator: Placebo
Participants will receive 2 doses of Placebo according to the immunization schedule of D0 & D21.
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The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
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Experimental: Investigational Vaccine 1b
Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP after 3 months following two doses of immunization.
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The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
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Experimental: Investigational Vaccine 2b
Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP after 3 months following two doses of immunization.
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The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
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Placebo Comparator: Placebo-b
Participants will receive a booster dose of Placebo after 3 months following two doses of immunization.
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The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The incidence of COVID-19 cases after two-doses of vaccination
Time Frame: From14 days after the second dose to 6 month after the second dose
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From14 days after the second dose to 6 month after the second dose
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The incidence of COVID-19 cases after the booster dose of immunization
Time Frame: From 14 days after the booster dose
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From 14 days after the booster dose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of any adverse reactions/events
Time Frame: 28 days after each immunization
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28 days after each immunization
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The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination
Time Frame: From 14 day after the second dose to 6 month after the second dose
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From 14 day after the second dose to 6 month after the second dose
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The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination
Time Frame: From 14 day after the booster dose
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From 14 day after the booster dose
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The incidence of serious adverse events (SAE)
Time Frame: From the beginning of the first dose to 12 months after the second immunization
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From the beginning of the first dose to 12 months after the second immunization
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The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after full course of immunization
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14 days after full course of immunization
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The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after full course of immunization
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14 days after full course of immunization
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The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after full course of immunization
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14 days after full course of immunization
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The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days, 28 days and 6th month after the booster dose
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14 days, 28 days and 6th month after the booster dose
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The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days, 28 days and 6th month after the booster dose
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14 days, 28 days and 6th month after the booster dose
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The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days, 28 days and 6th month after the booster dose
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14 days, 28 days and 6th month after the booster dose
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Other Outcome Measures
Outcome Measure |
Time Frame |
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the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19
Time Frame: 14 days after 2 doses of vaccination
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14 days after 2 doses of vaccination
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The occurrence of ADE
Time Frame: From the beginning of the first dose to 12 months after the second immunization
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From the beginning of the first dose to 12 months after the second immunization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Walid A Zaher, MD, MSc,PhD, G42 Healthcare company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022.
- Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, Al Nusair M, Hassany M, Jawad JS, Abdalla J, Hussein SE, Al Mazrouei SK, Al Karam M, Li X, Yang X, Wang W, Lai B, Chen W, Huang S, Wang Q, Yang T, Liu Y, Ma R, Hussain ZM, Khan T, Saifuddin Fasihuddin M, You W, Xie Z, Zhao Y, Jiang Z, Zhao G, Zhang Y, Mahmoud S, ElTantawy I, Xiao P, Koshy A, Zaher WA, Wang H, Duan K, Pan A, Yang X. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):35-45. doi: 10.1001/jama.2021.8565.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2020
Primary Completion (Actual)
June 16, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
August 3, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 12, 2020
Study Record Updates
Last Update Posted (Estimated)
June 19, 2023
Last Update Submitted That Met QC Criteria
June 15, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNBG2020003SQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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