Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19

NCT05165966 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2022-08-11

No results posted yet for this study

Summary

This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months

Conditions

Interventions

BIOLOGICAL

High-dosage of COVID-19 vaccine (Vero cell), Inactivated

High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated

Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yingmei Feng, Master · Beijing YouAn Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2022-04-20
Completion
2022-07-01

Countries

  • China

Study Locations

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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 NCT05165966 on ClinicalTrials.gov