Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884685
• Other study ID #: PRO-nCOV-2001
• Status: Completed
• Phase: Phase 2
• Start date: May 3, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: May 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 20, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
• Placebo
aluminium hydroxide solution only

Locations

Country	Name	City	State
China	Zanhuang county Center for Disease Control and Prevention	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Life Sciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety index-incidence of adverse reactions	Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.	Day 0-28 after each dose
Secondary	Safety index-incidence of adverse reactions	Incidence rate of adverse reactions within 7 days after each dose	Day 0-7 after each dose vaccination
Secondary	Safety index-incidence of serious adverse events	Incidence rate of serious adverse events from the beginning of the vaccination to 6 months after the second dose vaccination.	From the beginning of the vaccination to 6 months after the second dose vaccination