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A Phase 1 Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine

NCT06113744 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2023-11-08

No results posted yet for this study

Summary

A randomised, blinded, parallel-controlled phase 1 clinical trial to evaluate the safety and preliminary immunogenicity of a COVID-19 mRNA vaccine in a healthy population aged 18 years and older, and to investigate immunisation doses.

Conditions

Interventions

BIOLOGICAL

Placebo

saline

BIOLOGICAL

COVID-19 Vaccine (Vero Cell) ,Inactivated

COVILO

BIOLOGICAL

COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg

Low-dose

BIOLOGICAL

COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg

Mid-dose

BIOLOGICAL

COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg

High-dose

Sponsors & Collaborators

  • Shulan (Hangzhou) Hospital

    collaborator OTHER

  • CNBG-Virogin Biotech (Shanghai) Ltd.

    lead INDUSTRY

Principal Investigators

  • Yunkai Yang · China National Biotec Group Company Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-10
Primary Completion
2023-06-30
Completion
2024-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT06113744 on ClinicalTrials.gov