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

NCT04884685 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-09-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

SARS-CoV-2 Inactivated Vaccine

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

BIOLOGICAL

Placebo

aluminium hydroxide solution only

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuliang Zhao, Master · Hubei Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2021-08-01
Completion
2022-06-20

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884685 on ClinicalTrials.gov