Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells) in Children and Adolescents
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine
Eligibility Criteria
Inclusion Criteria:
- Aged 6-17 years;
- The subject and/or guardian can understand and voluntarily sign the informed consent form (double signature is required for 8-17 years old);
- Reproductive women have a negative pregnancy test before each vaccination;
- The subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 13.5 months.
Exclusion Criteria:
- History of SARS-CoV-2 infection.
- The COVID-19 antibody (IgG and IgM) screening was positive.
- History of asthma, history of allergy to vaccines or vaccine components, or severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioedema.
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Autoimmune diseases or immunodeficiency/immunosuppression.
- Severe chronic diseases that cannot be controlled by drugs, severe cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc.
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
- Any condition caused by thyroid disease or history of thyroidectomy, hypersplenism, or splenectomy.
- Diagnosis of abnormal blood clotting function (for example, lack of clotting factors, coagulopathy, abnormal platelets) or obvious bruising or blood clotting.
- In the past 6 months, received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis).
- Laboratory test results with clinically significant abnormalities (severity level 2 and above) (applicable to phase I clinical trials only).
- Received blood products in the last 3 months.
- Receive other study drugs or vaccines within the past 30 days.
- Vaccination against live attenuated vaccines in the past 30 days.
- Inactivated vaccine or subunit vaccine in the past 14 days.
- Acute disease or acute exacerbation of chronic disease in the last 7 days.
- Axillary temperature> 37.0°C.
- According to the judgment of the investigator, the subject has other factors that are not suitable for participating in the clinical trial.
Subsequent dose exclusion criteria:
In this trial, the second/third dose of vaccination may be stopped in some cases. This includes allergic reactions, severe hypersensitivity reactions, or grade 3 or higher adverse reactions that cannot be tolerated after previous vaccination/placebo. If these reactions occur, the subject should not continue to receive the second/third vaccination.
Sites / Locations
- Jiangsu Provincial Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Low-dose vaccine (6-11 years)
Medium-dose vaccine (6-11 years)
Medium-dose vaccine (12-17 years)
High-dose vaccine (12-17 years)
Low-dose placebo (6-11 years)
Medium-dose placebo (6-11 years)
Medium-dose placebo (12-17 years)
High-dose placebo (12-17 years)
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21,42.
three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21,42.
three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21,42.
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21,42.
three doses of low-dose placebo at the schedule of day 0, 21,42.
three doses of medium-dose placebo at the schedule of day 0, 21,42.
three doses of medium-dose placebo at the schedule of day 0, 21,42.
three doses of high-dose placebo at the schedule of day 0, 21,42.