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

NCT04884685 | Completed Phase 2

• 1 other identifier: PRO-nCOV-2001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

Biological: SARS-CoV-2 Inactivated Vaccine

Control Group

PLACEBO COMPARATOR

Placebo will receive two doses of placebo. The placebo will given by intramuscular injection on day 0 and day 28.

Biological: Placebo

Interventions

SARS-CoV-2 Inactivated Vaccine BIOLOGICAL

600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection

Also known as: CoronaVac

Experimental Group

Placebo BIOLOGICAL

aluminium hydroxide solution only

Control Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Zanhuang county Center for Disease Control and Prevention

Shijiazhuang, Hebei, 051230, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuliang Zhao, Master

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: May 3, 2021
• Primary Completion: August 1, 2021
• Study Completion: June 20, 2022
• Last Updated: September 22, 2023

Record last verified: 2021-05

Locations

CN (1)