A Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Adults Aged 18 Years and Older (COVID-19)

April 20, 2021 updated by: Shenzhen Kangtai Biological Products Co., LTD

A Multi-national, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated for the Prevention of COVID-19 in Healthy Adults Aged 18 Years and Older

The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Anticipated)

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.
28000

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy residents ≥ 18 years at the time of consent, be voluntary and capable of signing the informed consent forms.
  • Be able to understand and comply with study requirements/ procedures.
  • Participants with negative results of SARS-CoV-2 Realtime-PCR (RT-PCR) detection.
  • For females or sex-partners of males at childbearing age: be willing to use birth control for 3 months after the 2nd dose.
  • For females of childbearing potential (Pausimenia ≤ 2 years ) must: have a negative urine or blood pregnancy test at screening
  • Axillary temperature < 37.3℃/99.1℉ when screening (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).

Exclusion Criteria:

  • Previous treatments for curing or preventing COVID-19 (including vaccination of various COVID-19 vaccines).
  • History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
  • History of allergy to any components of the candidate vaccine or severe allergic reactions to vaccine or medicine (including, but not limited to, allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrosis (Arthus reaction)).
  • Positive for HIV detection.
  • History or family history of convulsion, epilepsy, encephalopathy, and psychosis.
  • Active stage of malignancies, malignancies without adequate treatments, malignancies with potential risk for recurrence during the study.
  • Severe or uncontrolled cardiovascular, neurological, blood and lymphatic, kidney, liver, respiratory, metabolic and skeletal diseases.
  • Congenital or functional absence of spleen, complete or partial removal of spleen in any case.
  • Chronic administration (defined as ≥ 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the 1st vaccination (eg. corticosteroids, ≥ 0.5 mg/kg/day prednisone or equivalent; but, inhaled and topical steroids are allowed).
  • Planned administration/administration of a vaccine not foreseen by the study protocol less than 7 days before 1st dose of candidate vaccine for inactivated vaccines or 14 days before 1st dose of candidate vaccine for attenuated live vaccines.
  • Receipt of blood products and/or immunoglobulins within 3 months prior to enrollment or expected receipt during the study.
  • Donate or loss ≥ 450 ml of blood within 1 month prior to enrollment, or expected blood donation during the study.
  • Fever: axillary temperature ≥ 37.3℃/99.1℉ within the past 24 hours (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).
  • Those who participated in other clinical trials 1 month prior to the enrollment or used any investigational or non-registered drug during the study period; Those who are unable to finish follow-up or fail in efficacy assessments.
  • Breastfeeding females should not be included.
  • Ineligible for the study based on the assessment of investigator.

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: Double

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.
Placebo Comparator: Placebo
Biological: Placebo
2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
Experimental: candidate vaccine
Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.

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
Measure Description
Time Frame
Incidence density of symptomatic COVID-19 cases
Time Frame: 14 days after full vaccination
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination.
14 days after full vaccination

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
Measure Description
Time Frame
Incidence density of COVID-19 moderate cases and above
Time Frame: 14 days after full vaccination
Incidence density of COVID-19 moderate cases and above occurring from 14 days after full vaccination.
14 days after full vaccination
Incidence density of COVID-19 severe cases and above
Time Frame: 14 days after full vaccination
Incidence density of COVID-19 severe cases and above occurring from 14 days after full vaccination.
14 days after full vaccination
Incidence density of COVID-19 death cases and above
Time Frame: 14 days after full vaccination
Incidence density of COVID-19 death cases and above occurring from 14 days after full vaccination.
14 days after full vaccination
Incidence density of symptomatic COVID-19 cases in different age groups
Time Frame: 14 days after full vaccination
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination in different age groups (18~59 years and ≥ 60 years).
14 days after full vaccination
Incidence of solicited local adverse events
Time Frame: 0-7 days after each vaccination
Incidence of solicited local adverse events occurring 0-7 days after each vaccination.
0-7 days after each vaccination
Incidence of solicited general adverse events
Time Frame: 0-7 days after each vaccination
Incidence of solicited general adverse events occurring 0-7 days after each vaccination.
0-7 days after each vaccination
Incidence of unsolicited adverse events
Time Frame: 0-28 days after each vaccination
Incidence of unsolicited adverse events occurring 0-28 days after each vaccination.
0-28 days after each vaccination
Incidence of SAE
Time Frame: from the 1st dose through the end of study
Incidence of SAE occurring from the 1st dose through the end of study.
from the 1st dose through the end of study
Incidence of AESI
Time Frame: from the 1st dose through the end of study
Incidence of AESI occurring from the 1st dose through the end of study.
from the 1st dose through the end of study
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time Frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Seroconversion rate of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Time Frame: 28 days, 90 days, 180 days and 360 days after full vaccination
geometric mean titer of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody
Time Frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
28 days, 90 days, 180 days and 360 days after full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Time Frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Time Frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody
Time Frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
28 days, 90 days, 180 days and 360 days after full vaccination

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.
Shenzhen Kangtai Biological Products Co., LTD

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 Minhai Biotechnology Co., Ltd

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 (Anticipated)

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.
May 1, 2021

Primary Completion (Anticipated)

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.
November 1, 2021

Study Completion (Anticipated)

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.
November 1, 2022

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).
April 20, 2021

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.
April 20, 2021

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.
April 21, 2021

Study Record Updates

Last Update Posted (Actual)

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.
April 22, 2021

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.
April 20, 2021

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.
April 1, 2021

More Information

Terms related to this study

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.
  • 2021L001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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