Efficacy,Immunogenicity and Safety of COVID-19 Vaccine , Inactivated Booster Dose in Adults Aged 18 Years and Above

NCT05156632 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-02-08

No results posted yet for this study

Summary

This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.

Conditions

Interventions

BIOLOGICAL

Medium-dosage COVID-19 Vaccine,Inactivated

The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection.

BIOLOGICAL

High-dosage COVID-19 Vaccine,Inactivated

The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.

BIOLOGICAL

Placebo-comparator group

The composition is aluminium hydroxide with no antigen ,0 SU/0.5 mL,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.

Sponsors & Collaborators

  • Sinovac Research and Development Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Javed Khan, Master · Rehman Medical Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2023-02-20
Completion
2023-02-20

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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 NCT05156632 on ClinicalTrials.gov