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Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19

NCT04551547 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2023-10-02

No results posted yet for this study

Summary

This study is a randomized, double-blinded, and placebo controlled phase 1\&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years

Conditions

Interventions

BIOLOGICAL

Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml

BIOLOGICAL

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml

OTHER

Two doses of placebo at the schedule of day 0,28

The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd.

Sponsors & Collaborators

  • Sinovac Research and Development 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
2020-10-31
Primary Completion
2021-04-30
Completion
2023-02-08

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04551547 on ClinicalTrials.gov