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Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above

NCT05663086 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-26

No results posted yet for this study

Summary

This is a randomized, blinded, positive-controlled study to evaluate the immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above（negative antibody against COVID-19）. 720 subjects will be recruited in this study, including 360 in 1 dose of 30 or 60 μg group and 360 in 2 doses of 30 or 60 μg group. The age group consists of 18-59 years old and 60 years old and above.

Conditions

Interventions

BIOLOGICAL

One dose group

The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

BIOLOGICAL

Two doses group

The vaccines are to be administrated at day 0 and 28. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

BIOLOGICAL

Aged 18-59 years

The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

BIOLOGICAL

Aged 60 years old and above

The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

Sponsors & Collaborators

  • Yantai Patronus Biotech Co., Ltd.

    collaborator INDUSTRY

  • Guangzhou Patronus Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengcai Zhu · Jiangsu Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-07
Primary Completion
2023-06-27
Completion
2023-06-27

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 NCT05663086 on ClinicalTrials.gov