Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Adults

Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 18 Years and Older: A Multicenter,Open-label Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04911790

Enrollment

131650

Registered

2021-06-03

Start date

2021-06-05

Completion date

2023-08-31

Last updated

2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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.

Detailed description

This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 18 years years and older. 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 May 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 121000 subjects will be enrolled with11000 for each research center, including at least 2000 people with pre-existing disease and at least 4000 people in the elderly group (60 years old and above) (including patients with pre-existing disease).And subjects will receive two doses of vaccine on day 0 and day 28.

Interventions

BIOLOGICALExperimental Group

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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 18 years and above; * 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 transverse myeliti,Guillain-Barre Syndrome and demyelinating disorders; * Acute diseas,acute onset of chronic disease and severe chronic diseases.

Design outcomes

Primary

Measure	Time frame	Description
Safety index-incidence of adverse reactions	Day 0-7 after each dose vaccination	Incidence rate of adverse reactions within 0\ 7 days after each dose in all populations.

Secondary

Measure	Time frame	Description
Safety index-incidence of adverse reactions	Day 0-7 after each dose vaccination	Incidence of adverse reactions within 0\ 7 days after each dose in the population with pre-existing disease.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026