search
Back to results

Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Experimental Group
Sponsored by
Sinovac Life Sciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have not received any COVID-19 vaccine in the past or at least one dose of CoronaVac manufactured by Sinovac Research and Development Co.,Ltd;
  • Population aged 3~17 years ;
  • The subjects can understand and voluntarily sign the informed consent form and participate in the follow-up;

Exclusion Criteria:

  • History of severe allergy to the vaccine such as acute allergic reaction,angioedema and dyspnea ;
  • Severe neurological disease such as Myelitis transverse,Guillain-Barre Syndrome and demyelinating disorders;
  • Acute disease,acute onset of chronic disease and severe chronic diseases.

Sites / Locations

  • Yongping Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

All of the participants(N=33000) will receive two doses inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28.

Outcomes

Primary Outcome Measures

Safety index 1-incidence of adverse reactions
Incidence rate of adverse reactions within 0~7 days after each dose in all populations.

Secondary Outcome Measures

Safety index 2-incidence of adverse reactions
Incidence rate of adverse reactions within 0~28 days after each dose in all populations
Safety index 3-incidence of adverse reactions
Incidence of adverse reactions within 0~7 days after each dose in each age group
Safety index 4-incidence of adverse reactions
Incidence rate of adverse reactions within 0~28 days after each dose in each age group
Safety index 5-incidence of adverse reactions
Incidence of adverse reactions within 0~7 days after each dose in the population with pre-existing disease.
Safety index 6-incidence of adverse reactions
Incidence of adverse reactions within 0~28 days after each dose in the population with pre-existing disease.

Full Information

First Posted
August 2, 2021
Last Updated
September 21, 2023
Sponsor
Sinovac Life Sciences Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04992208
Brief Title
Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents
Official Title
Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 3~17 Years : A Multicenter,Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 24, 2021 (Actual)
Primary Completion Date
March 24, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a multi-center and open design, phase Ⅳ 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 population aged 3~17 years and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.
Detailed Description
This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 3~17 years . The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in 11 provinces from August 2021 to December 2022, including Liaoning, Heilongjiang, Anhui, Fujian, Jiangxi, Hubei, Guangxi, Chongqing, Guizhou, Yunnan and Gansu. Each province will serve as a research center, and each research center will select the corresponding research site.A total of 33000 subjects including patients with pre-existing will be enrolled with 3000 for each research center, including 600 subjects aged 3~5years，1200 subjects aged 6~11 years,1200 subjects aged 12~17 years. And subjects will receive two doses of vaccine on day 0 and day 28.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31041 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
All of the participants(N=33000) will receive two doses inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28.
Intervention Type
Biological
Intervention Name(s)
Experimental Group
Other Intervention Name(s)
CoronaVac
Intervention Description
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Primary Outcome Measure Information:
Title
Safety index 1-incidence of adverse reactions
Description
Incidence rate of adverse reactions within 0~7 days after each dose in all populations.
Time Frame
Within 0~7 days after each dose
Secondary Outcome Measure Information:
Title
Safety index 2-incidence of adverse reactions
Description
Incidence rate of adverse reactions within 0~28 days after each dose in all populations
Time Frame
Within 0-28 days after each dose vaccination
Title
Safety index 3-incidence of adverse reactions
Description
Incidence of adverse reactions within 0~7 days after each dose in each age group
Time Frame
Within 0~7 days after each dose vaccination
Title
Safety index 4-incidence of adverse reactions
Description
Incidence rate of adverse reactions within 0~28 days after each dose in each age group
Time Frame
Within 0~28 days after each dose vaccination
Title
Safety index 5-incidence of adverse reactions
Description
Incidence of adverse reactions within 0~7 days after each dose in the population with pre-existing disease.
Time Frame
Within 0~7 days after each dose vaccination
Title
Safety index 6-incidence of adverse reactions
Description
Incidence of adverse reactions within 0~28 days after each dose in the population with pre-existing disease.
Time Frame
Within 0~28 days after each dose vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have not received any COVID-19 vaccine in the past or at least one dose of CoronaVac manufactured by Sinovac Research and Development Co.,Ltd; Population aged 3~17 years ; The subjects can understand and voluntarily sign the informed consent form and participate in the follow-up; Exclusion Criteria: History of severe allergy to the vaccine such as acute allergic reaction,angioedema and dyspnea ; Severe neurological disease such as Myelitis transverse,Guillain-Barre Syndrome and demyelinating disorders; Acute disease,acute onset of chronic disease and severe chronic diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Liu, Doctor
Organizational Affiliation
Yunnan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xing Fang
Organizational Affiliation
Liaoning Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhaodan Sun
Organizational Affiliation
HeilongjiangProvincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fubing Wang
Organizational Affiliation
Hefei Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongjuan Zhang
Organizational Affiliation
Center for Disease Control and Prevention, Fujian
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shicheng Guo
Organizational Affiliation
Jiangxi Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yeqing Tong
Organizational Affiliation
Hubei Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qiuyun Deng
Organizational Affiliation
Guangxi Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qing Wang
Organizational Affiliation
Chongqing Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruizhi Zhang
Organizational Affiliation
Guizhou Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoshu Zhang
Organizational Affiliation
Gansu Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yongping Center for Diseases Control and Prevention
City
Dali
State/Province
Yunnan
ZIP/Postal Code
650022
Country
China

12. IPD Sharing Statement

Learn more about this trial

Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents

We'll reach out to this number within 24 hrs