Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551547
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 16, 2020
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE October 31, 2020
Actual Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]
    Incidence of adverse reactions 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19
Official Title  ICMJE 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
Brief Summary 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Experimental Vaccine-low dosage
    low dosage inactivated SARS-CoV-2 vaccine
    Intervention: Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
  • Experimental: Experimental Vaccine-medium dosage
    medium dosage inactivated SARS-CoV-2 vaccine
    Intervention: Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
  • Placebo Comparator: Placebo
    No active ingredient in the placebo
    Intervention: Other: Two doses of placebo at the schedule of day 0,28
Publications * Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z, Li M, Lian X, Jiao W, Wang L, Shu Q, Wu Z, Zhao Y, Li Q, Gao Q. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun 28. pii: S1473-3099(21)00319-4. doi: 10.1016/S1473-3099(21)00319-4. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
552
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Actual Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04551547
Other Study ID Numbers  ICMJE PRO-nCOV-1003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )
Study Sponsor  ICMJE Sinovac Research and Development Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuliang Zhao, Master Hubei Provincial Center for Disease Control and Prevention
PRS Account Sinovac Biotech Co., Ltd
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP