Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2 360 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
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2 360 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
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2 360 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
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3 360 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
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3 360 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
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3 360 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
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Active Comparator: Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1 360 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
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 [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 Outcome Measures
- Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 [28 days after the full immunization]
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
- Seroconversion rate 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 of each lot of COVID-19 vaccine
- Seropositivity 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 of each lot of COVID-19 vaccine
- Incidence of adverse reactions 0-7 days after vaccination [0-7 days after vaccination]
The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination
- Incidence of adverse reactions 0-28 days after vaccination [0-28 days after vaccination]
The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination
Eligibility Criteria
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)
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yaliang county Center for Disease Control and Prevention | Xi'an | Shanxi | China | 710054 |
Sponsors and Collaborators
- Sinovac Research and Development Co., Ltd.
Investigators
- Principal Investigator: Weijun Hu, Master, Shanxi Provincial Center for Disease Prevention and Control
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-nCOV-MA4006-SN