COVID-19 Clinical Trial
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
Verified date | June 2021 |
Source | Sinovac Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 552 |
Est. completion date | February 8, 2023 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Zanhuang county Center for Disease Control and Prevention | Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Sinovac Research and Development Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Phase ?: The seropositive rate of neutralizing antibody | 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 | |
Other | Phase ?:The GMT of neutralizing antibody | 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. | |
Other | Phase ?: The seropositive rate of neutralizing antibody | 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 | |
Other | Phase ?: The GMT of neutralizing antibody | 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. | |
Other | Phase ?: The seropositive rate | 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 | |
Other | Phase ?: The GMT | 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 | |
Other | Phase ?: The GMI | 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 | |
Other | Phase ?: the seropositive rate | 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 | |
Other | Phase ?: the GMT | 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 | |
Primary | Safety index-incidence of adverse reactions | Incidence of adverse reactions after each dose vaccination. | Day 0-28 after each dose vaccination | |
Primary | Immunogenicity index-seroconversion rates of neutralizing antibody | 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 | Safety index-incidence of serious adverse events | SAE will be collected throughout the clinical trial. | From the beginning of the vaccination to 12 months after the second dose vaccination | |
Secondary | Immunogenicity index-seropositive rates of neutralizing antibody | 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 | |
Secondary | Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody | 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 | |
Secondary | Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody | 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 | |
Secondary | Safety index-Incidence rate of adverse reactions | Incidence rate of adverse reactions within 7 days after each dose vaccination | Within 7 days after each dose vaccination | |
Secondary | Safety index-Incidence of abnormal laboratory index | 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 ? | On the 3th day after each dose of vaccination in phase ? | |
Secondary | Safety index-Incidence rate of AESIs | 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 | |
Secondary | Immunogenicity index- GMI of neutralizing antibody | GMI of neutralizing antibodies 28 days after the second dose vaccination | 28 days after the second dose vaccination | |
Secondary | Immunogenicity index-the seroconversion rate | The seroconversion rate 28 days after the first dose vaccination in phase ? | 28 days after the first dose vaccination in phase ? | |
Secondary | Immunogenicity index-the seropositive rate | Seropositive rate 28 days after the first dose vaccination in phase ? | 28 days after the first dose vaccination in phase ? | |
Secondary | Immunogenicity index-the GMT | The GMT 28 days after the first dose vaccination in phase ? | 28 days after the first dose vaccination in phase ? | |
Secondary | Immunogenicity index-the GMI | The GMI 28 days after the first dose vaccination in phase ? | 28 days after the first dose vaccination in phase ? |
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