A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac）Between Different Workshops for Prevention of COVID-19 in Healthy Children Aged 3-17 Years
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Sinovac Research and Development Co., Ltd.
- Enrollment
- 2520
- Locations
- 1
- Primary Endpoint
- Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac)manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency ,immunogenicity and safety of COVID-19 vaccine between the commercialized scale in workshop 2 and 3 and the commercialized scale in workshop 1 in healthy children aged 3-17 years.
Detailed Description
This study is a double-blind, randomized phase Ⅳ clinical trial in healthy children aged 3-17 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy children aged 3-17 years .The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. A total of 2520 healthy subjects aged 3 to 17 years old will be enrolled.The subjects will be randomly divided into 7 groups of 360 participants per group with an equal probability to received 7 batches of commercial-scale vaccine.All subjects received two doses of vaccine on day 0 and day 28.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy children aged 3-17;
- •The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form)
- •Proven legal identity.
Exclusion Criteria
- •History of SARS-CoV-2 infection;
- •History of receiving COVID-19 vaccine;
- •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 (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation)
- •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,absence of spleen, functional absence of spleen, absence of spleen due to any condition or splenectomy;
- •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;
Outcomes
Primary Outcomes
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
Time Frame: 28 days after the full immunization
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
Secondary Outcomes
- Incidence of adverse reactions 0-28 days after vaccination(0-28 days after vaccination)
- Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2(28 days after the full immunization)
- Seroconversion rate of the neutralizing antibody to live SARS-CoV-2(28 days after the full immunization)
- Seropositivity rate of the neutralizing antibody to live SARS-CoV-2(28 days after the full immunization)
- Incidence of adverse reactions 0-7 days after vaccination(0-7 days after vaccination)