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Clinical Trial of COVID-19 Vaccine（SARS-CoV-2 Variant(Omicron BA.5) mRNA Vaccine） in Participants Aged 18 Years and Over

NCT05745545 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3200

Last updated 2023-02-28

No results posted yet for this study

Summary

This is a single-center, randomized, blinded, placebo-controlled clinical trial to evaluate the protective efficacy, safety and immunogenicity of one dose of the SARS-CoV-2 variant (Omicron BA.5) mRNA vaccine in people aged 18 years and older who had received two or three doses of inactivated COVID-19 vaccine.

Conditions

Interventions

BIOLOGICAL

SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine

One dose was administered by intramuscular injection, 100μg，1.0ml/dose

DRUG

Saline solution

One dose was administered by intramuscular injection, 0.5ml/vial

Sponsors & Collaborators

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Ningbo Rongan Biological Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • AIM Vaccine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Huan Zhou · The First Affiliated Hospital of Bengbu Medical University

  • Qiang Wu · The First Affiliated Hospital of Bengbu Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2023-09-30
Completion
2023-11-30

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 NCT05745545 on ClinicalTrials.gov