NCT04884685CompletedPhase 2
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.
Sinovac Life Sciences Co., Ltd.1 site in 1 country500 target enrollmentStarted: May 3, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Safety index-incidence of adverse reactions
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 3 Years to 17 Years (Child)
- Sex
- 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.
Arms & Interventions
Experimental Group
Experimental
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.
Intervention: SARS-CoV-2 Inactivated Vaccine (Biological)
Control Group
Placebo Comparator
Placebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28.
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Safety index-incidence of adverse reactions(Day 0-7 after each dose vaccination)
- Safety index-incidence of serious adverse events(From the beginning of the vaccination to 6 months after the second dose vaccination)
Investigators
Study Sites (1)
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