NCT04911790

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 18 years years and older and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131,650

participants targeted

Target at P75+ for phase_4 covid19

Timeline
Completed

Started Jun 2021

Longer than P75 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 5, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

September 25, 2023

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

June 2, 2021

Last Update Submit

September 21, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Safety index-incidence of adverse reactions

    Incidence rate of adverse reactions within 0\~7 days after each dose in all populations.

    Day 0-7 after each dose vaccination

Secondary Outcomes (3)

  • Safety index-incidence of adverse reactions

    Day 0-7 after each dose vaccination

  • Safety index-incidence of adverse reactions

    Day 0-28 after each dose vaccination

  • Safety index-incidence of adverse reactions

    Day 0-28 after each dose vaccination

Study Arms (1)

Experimental Group

EXPERIMENTAL

Participant will receive two doses inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28.

Biological: Experimental Group

Interventions

Experimental GroupBIOLOGICAL

SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection

Also known as: CoronaVac
Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 18 years and above;
  • The subjects can understand and voluntarily sign the informed consent form and participate in the follow-up;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongping Center for Diseases Control and Prevention

Dali, Yunnan, 650022, China

Location

Related Publications (1)

  • Yang H, Li Z, Zhang R, Guo S, Wang B, Fang X, Zhang D, Zhang X, Tong Y, Wang Q, Deng Q, Sun Z, Liu X, Gao Y. Safety of primary immunization using inactivated SARS-CoV-2 vaccine (CoronaVac(R)) among population aged 3 years and older in a large-scale use: A multi-center open-label study in China. Vaccine. 2023 Feb 10;41(7):1354-1361. doi: 10.1016/j.vaccine.2023.01.020. Epub 2023 Jan 13.

    PMID: 36658045DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Xiaoqiang Liu, Doctor

    Yunnan Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Xing Fang

    Liaoning Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Zhaodan Sun

    HeilongjiangProvincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Fubing Wang

    Hefei Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Dongjuan Zhang

    Center for Disease Control and Prevention, Fujian

    PRINCIPAL INVESTIGATOR

  • Shicheng Guo

    Jiangxi Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Yeqing Tong

    Hubei Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Qiuyun Deng

    Guangxi Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Qing Wang

    Chongqing Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Ruizhi Zhang

    Guizhou Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Xiaoshu Zhang

    Gansu Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 3, 2021

Study Start

June 5, 2021

Primary Completion

January 2, 2023

Study Completion

August 31, 2023

Last Updated

September 25, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)