Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents
Study Details
Study Description
Brief Summary
This study is a randomized, double-blinded, placebo-controlled, phase Ⅱb clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in healthy children and adolescents aged 3-17 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study is a randomized, double-blinded, placebo-controlled,phase Ⅱb clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 500 subjects will be enrolled, including 100 children aged 3-5 years, 200 children aged 6-11 years and 200 adolescents aged 12-17 years. Each age group will be randomly divided into two groups in a 3:1 ratio and received two doses of experimental vaccine or placebo on on day 0 and day 28.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Biological: SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Placebo Comparator: Control Group Placebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28. |
Biological: Placebo
aluminium hydroxide solution only
|
Outcome Measures
Primary Outcome Measures
- Safety index-incidence of adverse reactions [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.
Secondary Outcome Measures
- Safety index-incidence of adverse reactions [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy children and adolescents aged 3-17 years;
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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);
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Proven legal identity.
Exclusion Criteria:
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Travel history / residence history of communities with case reports within 14 days;
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History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
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Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
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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;
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History of SARS-CoV-2 infection;
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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;
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Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
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Autoimmune disease or immunodeficiency / immunosuppression;
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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.;
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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
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Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
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Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
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History of alcohol or drug abuse;
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Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
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Receipt of blood products within in the past 3 months;
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Receipt of other investigational drugs in the past 30 days;
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Receipt of attenuated live vaccines in the past 14 days;
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Receipt of inactivated or subunit vaccines in the past 7 days;
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Axillary temperature >37.0°C;
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Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
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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 | Zanhuang county Center for Disease Control and Prevention | Shijiazhuang | Hebei | China | 051230 |
Sponsors and Collaborators
- Sinovac Life Sciences Co., Ltd.
Investigators
- Principal Investigator: Yuliang Zhao, Master, Hubei Provincial Center for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-nCOV-2001