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Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or Older

NCT05683600 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2023-09-28

No results posted yet for this study

Summary

This is an international multicenter clinical trial, which is planned to be conducted in several research centers in China and Pakistan. A randomized, double-blind, placebo-controlled design will be conducted to evaluate the efficacy, safety of LYB001 against COVID-19 as a booster dose in China.

Conditions

Interventions

BIOLOGICAL

Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001

Intramuscular injection of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.

BIOLOGICAL

Placebo

Intramuscular injection of placebo in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.

Sponsors & Collaborators

  • Yantai Patronus Biotech Co., Ltd.

    collaborator INDUSTRY

  • Guangzhou Patronus Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chengyong Tang · Chongqing Bishan District People's Hospital

  • Li Zhang · Shandong Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2023-07-12
Completion
2023-07-12

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT05683600 on ClinicalTrials.gov