Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2
* Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2
* Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2
* Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3
* Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3
* Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3
* Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1


Participation Criteria
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Eligibility Criteria
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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; 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; Onset of various acute or chronic diseases within 7 days prior to the study; Axillary temperature >37.0°C; The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months; Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 months; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2<br>360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2 according to 0,28-day immunization schedule. | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2<br>360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2 according to 0,28-day immunization schedule. | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2<br>360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2 according to 0,28-day immunization schedule. | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3<br>360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3 according to 0,28-day immunization schedule. | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3<br>360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3 according to 0,28-day immunization schedule. | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3<br>360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3 according to 0,28-day immunization schedule. | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|
| Active Comparator: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1<br>360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1 according to 0,28-day immunization schedule. | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 | 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 | 28 days after the full immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 | Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine | 28 days after the full immunization | 
| Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 | Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine | 28 days after the full immunization | 
| Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 | Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine | 28 days after the full immunization | 
| Incidence of adverse reactions 0-7 days after vaccination | The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination | 0-7 days after vaccination | 
| Incidence of adverse reactions 0-28 days after vaccination | The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination | 0-28 days after vaccination |