This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivatedSARS-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 andsafety of COVID-19 vaccine between the commercialized scale in workshop 2 and 3 and thecommercialized scale in workshop 1 in healthy children aged 3-17 years.
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.
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 Name: CoronaVac
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 Name: CoronaVac
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 Name: CoronaVac
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 Name: CoronaVac
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 Name: CoronaVac
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 Name: CoronaVac
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 Name: CoronaVac
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.
Yaliang county Center for Disease Control and Prevention
Xi'an, Shanxi, China
Weijun Hu, Master, Principal Investigator
Shanxi Provincial Center for Disease Prevention and Control