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Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above

NCT05381350 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1750

Last updated 2024-05-31

No results posted yet for this study

Summary

This is a randomized, double-blind, active-controlled Phase Ⅲ clinical trial, as well as an immuno-bridging clinical trial by parallel testing previous serum after primary immunization of COVID-19 vaccine (Vero cell), inactivated (Omicron variant). The main purpose of this study is to evaluate the superiority of immunogenicity against SARS-CoV-2 Omicron strain induced by one-dose booster immunization of inactivated COVID-19 vaccine (Omicron variant), developed by Sinovac Research and Development Co., Ltd.in subjects who have received two- or three-dose Prototype COVID-19 vaccine （CZ strain）, compared with one-dose booster of Prototype COVID-19 vaccine （CZ strain） in subjects who have received three-dose Prototype COVID-19 vaccine （CZ strain）, and to evaluate the non-inferiority of immunogenicity against SARS-CoV-2 Omicron strain induced by one-dose booster immunization of inactivated COVID-19 vaccine (Omicron variant), developed by Sinovac Research and Development Co., Ltd., in subjects who have received two- or three-dose Prototype COVID-19 vaccine, compared with the immunogenicity against SARS-CoV-2 Prototype strain induced by two-dose Prototype COVID-19 vaccine（CZ strain）after primary immunization.

Conditions

Interventions

BIOLOGICAL

COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)

The COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)was manufactured by Sinovac Research\& Development Co., Ltd.1200SOU inactivated SARS-CoV-2 Omicron strain in 0.5ml of aluminium hydroxide solution per injection.

BIOLOGICAL

COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)

The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.

Sponsors & Collaborators

  • Sinovac Research and Development 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
2022-06-01
Primary Completion
2022-09-26
Completion
2023-03-09

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 NCT05381350 on ClinicalTrials.gov