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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Sinovac Research and Development Co., Ltd.
- Enrollment
- 552
- Locations
- 1
- Primary Endpoint
- Safety index-incidence of adverse reactions
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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. Subjects in Phase receive the second dose 10 months or 12 months after the second dose.
Investigators
Eligibility 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;
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody(The 28th day after each dose vaccination and the 12 month after the second dose vaccination)
- Safety index-Incidence rate of adverse reactions(Within 7 days after each dose vaccination)
- Safety index-Incidence of abnormal laboratory index(On the 3th day after each dose of vaccination in phase Ⅰ)
- Immunogenicity index-the seroconversion rate(28 days after the first dose vaccination in phase Ⅰ)
- Immunogenicity index-the seropositive rate(28 days after the first dose vaccination in phase Ⅰ)
- Immunogenicity index-the GMI(28 days after the first dose vaccination in phase Ⅰ)
- Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody(The 28th day after each dose vaccination and the 12 month after the second dose vaccination)
- Immunogenicity index-the GMT(28 days after the first dose vaccination in phase Ⅰ)
- Safety index-incidence of serious adverse events(From the beginning of the vaccination to 12 months after the second dose vaccination)
- Immunogenicity index-seropositive rates of neutralizing antibody(The 28th day after each dose vaccination and the 12 month after the second dose vaccination)
- Safety index-Incidence rate of AESIs(From the beginning of the vaccination to 12 months after the last dose vaccination)
- Immunogenicity index- GMI of neutralizing antibody(28 days after the second dose vaccination)