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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Bahrain
      • Sanabis, Bahrain
        • Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S
  • Egypt
      • Cairo, Egypt, 11835
        • Katameya Medical Center
      • Cairo, Egypt, 22311
        • Vacsera health Care facilities , MoH
  • Jordan
      • Amman, Jordan
        • Prince Hamza Hospital
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 51900
        • Sheikh Khalifa Medical City, SEHA
      • Sharjah, United Arab Emirates, 61545
        • Al Qarain Primary Health Care Centre-MOHAP

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy subjects aged 18 years old and above.
  2. By asking for medical history and physical examination, the investigator judged that the health condition is well.
  3. 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.
  4. During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
  5. 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:

  1. Confirmed acute cases of SARS-CoV-2 Infection.
  2. Have a history of SARS, MERS infection (self-report, on-site inquiry).
  3. Positive urine pregnancy test result.
  4. 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.
  5. Axillary body temperature > 37.0 ℃ before vaccination.
  6. 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.
  7. Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
  8. With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  9. 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.
  10. Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
  11. 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.
  12. Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
  13. Receiving anti-TB therapy.
  14. Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
  15. Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
  16. Received blood products within 3 months before this vaccination
  17. Received other research drugs within 6 months before this vaccination.
  18. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
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.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
Placebo Comparator: Placebo
Participants will receive 2 doses of Placebo according to the immunization schedule of D0 & D21.
Biological: Placebo
The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
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.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
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.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
Placebo Comparator: Placebo-b
Participants will receive a booster dose of Placebo after 3 months following two doses of immunization.
Biological: Placebo
The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
From14 days after the second dose to 6 month after the second dose
The incidence of COVID-19 cases after the booster dose of immunization
Time Frame: From 14 days after the booster dose
From 14 days after the booster dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The incidence of any adverse reactions/events
Time Frame: 28 days after each immunization
28 days after each immunization
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
From 14 day after the second dose to 6 month after the second dose
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
From 14 day after the booster dose
The incidence of serious adverse events (SAE)
Time Frame: From the beginning of the first dose to 12 months after the second immunization
From the beginning of the first dose to 12 months after the second immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after full course of immunization
14 days after full course of immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after full course of immunization
14 days after full course of immunization
The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time Frame: 14 days after full course of immunization
14 days after full course of immunization
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
28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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
28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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
28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
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
14 days, 28 days and 6th month after the booster dose
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
14 days, 28 days and 6th month after the booster dose
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
14 days, 28 days and 6th month after the booster dose

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19
Time Frame: 14 days after 2 doses of vaccination
14 days after 2 doses of vaccination
The occurrence of ADE
Time Frame: From the beginning of the first dose to 12 months after the second immunization
From the beginning of the first dose to 12 months after the second immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Biotec Group Company Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Institute of Biological Products Co Ltd.
Wuhan Institute of Biological Products Co., Ltd
Abu Dhabi Health Services Company
G42 Healthcare company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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