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Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19

NCT05079217 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2022-03-02

No results posted yet for this study

Summary

This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.

Conditions

Interventions

BIOLOGICAL

High-dosage SARS-CoV-2 vaccine

SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

Medium-dosage SARS-CoV-2 vaccine

SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Hongxing Pan, Master · Jiangsu Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2021-12-21
Completion
2022-06-01

Countries

  • China

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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 NCT05079217 on ClinicalTrials.gov