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

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ClinicalTrials.gov Identifier: NCT04884685
Recruitment Status : Active, not recruiting
First Posted : May 13, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

Study Description
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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 Research and Development 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
COVID-19 Biological: SARS-CoV-2 Inactivated Vaccine Biological: Placebo 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 Research and Development 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : January 3, 2022
Arms and Interventions
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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 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.
 Biological: Placebo
aluminium hydroxide solution only


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China, Hebei
Zanhuang county Center for Disease Control and Prevention
Shijiazhuang, Hebei, China, 051230
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Principal Investigator: Yuliang Zhao, Master Hubei Provincial Center for Disease Control and Prevention
More Information
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04884685    
Other Study ID Numbers: PRO-nCOV-2001
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No