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Trial record 2 of 41 for:    Sinovac | Child

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551547
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Other: Two doses of placebo at the schedule of day 0,28 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 552 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 31, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]
    Incidence of adverse reactions after each dose vaccination.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551547


Contacts
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Contact: Yuliang Zhao, Master 86-13315290538 yuliang_zh@163.com

Locations
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China, Hebei
Zanhuang county Center for Disease Control and Prevention Recruiting
Shijiazhuang, Hebei, China, 051230
Contact: Hui Jin    86-13930778699    1206618652@qq.com   
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Principal Investigator: Yuliang Zhao, Master Hubei Provincial Center for Disease Control and Prevention
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04551547    
Other Study ID Numbers: PRO-nCOV-1003
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs