Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19

September 29, 2023 updated by: Sinovac Research and Development Co., Ltd.

A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine (Vero Cell) in Healthy Population Aged 3-17 Years

This study is a randomized, double-blinded, and placebo controlled phase 1&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years

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 study is a randomized, double-blinded, single-center, placebo-controlled phase 1&2 clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 552 subjects will be enrolled, with 72 at phase 1, and 480 at phase 2. Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 0,28. Subjects in Phase receive the second dose 10 months or 12 months after the second dose.

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.
552

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 2
  • Phase 1

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

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 051230
        • Zanhuang county Center for Disease Control and Prevention

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

3 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy children and adolescents aged 3-17 years;
  • The subject and/or guardian can understand and voluntarily sign the informed consent form (double sign required for 8-17 years old);
  • Proven legal identity.

Exclusion Criteria:

  • Travel history / residence history of communities with case reports within 14 days;
  • History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
  • Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
  • Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days;
  • History of SARS-CoV-2 infection;
  • History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;

  • Physical examination has clinically significant abnormal hematology and biochemistry laboratory test results that exceed the reference value range (only applicable to phase I clinical trials):

    1. Blood routine test: white blood cell count, hemoglobin, platelet count;
    2. Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;
    3. Urine routine index: urine protein (PRO);
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
  • Axillary temperature >37.0°C;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the 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: 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.
Experimental: Experimental Vaccine-low dosage
low dosage inactivated SARS-CoV-2 vaccine
Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 300SU/0.5ml
Experimental: Experimental Vaccine-medium dosage
medium dosage inactivated SARS-CoV-2 vaccine
Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml
Placebo Comparator: Placebo
No active ingredient in the placebo
Other: Two doses of placebo at the schedule of day 0,28
The placebo contains no active ingredient and manufactured by Sinovac Research & Development Co., Ltd.

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
Safety index-incidence of adverse reactions
Time Frame: Day 0-28 after each dose vaccination
Incidence of adverse reactions after each dose vaccination.
Day 0-28 after each dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
Time Frame: The 28th day after the second dose vaccination
Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.
The 28th day after the second dose 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
Safety index-incidence of serious adverse events
Time Frame: From the beginning of the vaccination to 12 months after the second dose vaccination
SAE will be collected throughout the clinical trial.
From the beginning of the vaccination to 12 months after the second dose vaccination
Immunogenicity index-seropositive rates of neutralizing antibody
Time Frame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive.
The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Time Frame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Neutralizing antibody assay will be performed using the micro-neutralization method.
The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody
Time Frame: The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.
The 28th day after each dose vaccination and the 12 month after the second dose vaccination
Safety index-Incidence rate of adverse reactions
Time Frame: Within 7 days after each dose vaccination
Incidence rate of adverse reactions within 7 days after each dose vaccination
Within 7 days after each dose vaccination
Safety index-Incidence of abnormal laboratory index
Time Frame: On the 3th day after each dose of vaccination in phase Ⅰ
Incidence of abnormal laboratory index (blood routine test, blood chemistry test, and urine routine test) on the 3th day after each dose of vaccination in phase Ⅰ
On the 3th day after each dose of vaccination in phase Ⅰ
Safety index-Incidence rate of AESIs
Time Frame: From the beginning of the vaccination to 12 months after the last dose vaccination
Incidence rate of SAEs and AESIs from the beginning of the vaccination to 12 months after the last dose vaccination
From the beginning of the vaccination to 12 months after the last dose vaccination
Immunogenicity index- GMI of neutralizing antibody
Time Frame: 28 days after the second dose vaccination
GMI of neutralizing antibodies 28 days after the second dose vaccination
28 days after the second dose vaccination
Immunogenicity index-the seroconversion rate
Time Frame: 28 days after the first dose vaccination in phase Ⅰ
The seroconversion rate 28 days after the first dose vaccination in phase Ⅰ
28 days after the first dose vaccination in phase Ⅰ
Immunogenicity index-the seropositive rate
Time Frame: 28 days after the first dose vaccination in phase Ⅰ
Seropositive rate 28 days after the first dose vaccination in phase Ⅰ
28 days after the first dose vaccination in phase Ⅰ
Immunogenicity index-the GMT
Time Frame: 28 days after the first dose vaccination in phase Ⅰ
The GMT 28 days after the first dose vaccination in phase Ⅰ
28 days after the first dose vaccination in phase Ⅰ
Immunogenicity index-the GMI
Time Frame: 28 days after the first dose vaccination in phase Ⅰ
The GMI 28 days after the first dose vaccination in phase Ⅰ
28 days after the first dose vaccination in phase Ⅰ

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
Measure Description
Time Frame
Phase Ⅰ: The seropositive rate of neutralizing antibody
Time Frame: 6 months and 12 months after the second dose vaccination
The seropositive rate of neutralizing antibody against live SARS-CoV-2 6 months and 12 months after the second dose vaccination
6 months and 12 months after the second dose vaccination
Phase Ⅰ:The GMT of neutralizing antibody
Time Frame: 6 months and 12 months after the second dose vaccination.
The GMT of neutralizing antibody against live SARS-CoV-2 6 months and 12 months after the second dose vaccination.
6 months and 12 months after the second dose vaccination.
Phase Ⅱ: The seropositive rate of neutralizing antibody
Time Frame: 3 months, 6 months, 9 months and 12 months after the second dose vaccination
The seropositive rate of neutralizing antibody against live SARS-CoV-2 3 months, 6 months, 9 months and 12 months after the second dose vaccination
3 months, 6 months, 9 months and 12 months after the second dose vaccination
Phase Ⅱ: The GMT of neutralizing antibody
Time Frame: 3 months, 6 months, 9 months and 12 months after the second dose vaccination.
The GMT of neutralizing antibody against live SARS-CoV-2 3 months, 6 months, 9 months and 12 months after the second dose vaccination.
3 months, 6 months, 9 months and 12 months after the second dose vaccination.
Phase Ⅱ: The seropositive rate
Time Frame: 28 days after the booster dose
The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 28 days after the booster dose
28 days after the booster dose
Phase Ⅱ: The GMT
Time Frame: 28 days after the booster dose
The GMT of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 28 days after the booster dose
28 days after the booster dose
Phase Ⅱ: The GMI
Time Frame: 28 days after the booster dose
The GMI of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 28 days after the booster dose
28 days after the booster dose
Phase Ⅱ: the seropositive rate
Time Frame: 6 months and 12 months after the booster dose
The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 6 months and 12 months after the booster dose.
6 months and 12 months after the booster dose
Phase Ⅱ: the GMT
Time Frame: 6 months and 12 months after the booster dose
The GMT of neutralizing antibody against Prototype SARS-CoV-2 and Omicron strain 6 months and 12 months after the booster dose.
6 months and 12 months after the booster dose

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.
Sinovac Research and Development Co., Ltd.

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.
  • Principal Investigator: Yuliang Zhao, Master, Hubei Provincial Center for Disease Control and Prevention

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.
October 31, 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.
April 30, 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.
February 8, 2023

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).
September 15, 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.
September 15, 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.
September 16, 2020

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.
October 2, 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.
September 29, 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, 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.
  • PRO-nCOV-1003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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