Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04884685 |
Recruitment Status :
Completed
First Posted : May 13, 2021
Last Update Posted : August 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Biological: SARS-CoV-2 Inactivated Vaccine Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial, to Evaluate the Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 3 to 17 Years. |
Actual Study Start Date : | May 3, 2021 |
Actual Primary Completion Date : | August 1, 2021 |
Actual Study Completion Date : | June 20, 2022 |

Arm | Intervention/treatment |
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Experimental: Experimental Group
Participant will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28.
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Biological: SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac |
Placebo Comparator: Control Group
Placebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28.
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Biological: Placebo
aluminium hydroxide solution only |
- Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose ]Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.
- Safety index-incidence of adverse reactions [ Time Frame: Day 0-7 after each dose vaccination ]Incidence rate of adverse reactions within 7 days after each dose
- Safety index-incidence of serious adverse events [ Time Frame: From the beginning of the vaccination to 6 months after the second dose vaccination ]Incidence rate of serious adverse events from the beginning of the vaccination to 6 months after the second dose vaccination.

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Ages Eligible for Study: | 3 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy children and adolescents aged 3-17 years;
- 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:
- Travel history / residence history of communities with case reports within 14 days;
- History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
- Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
- Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days;
- History of SARS-CoV-2 infection;
- 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 or immunodeficiency / immunosuppression;
- 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, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
- 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;
- History of alcohol or drug abuse;
- Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
- 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;
- Axillary temperature >37.0°C;
- Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884685
China, Hebei | |
Zanhuang county Center for Disease Control and Prevention | |
Shijiazhuang, Hebei, China, 051230 |
Principal Investigator: | Yuliang Zhao, Master | Hubei Provincial Center for Disease Control and Prevention |
Responsible Party: | Sinovac Life Sciences Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04884685 |
Other Study ID Numbers: |
PRO-nCOV-2001 |
First Posted: | May 13, 2021 Key Record Dates |
Last Update Posted: | August 12, 2022 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |