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A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults

NCT05960097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2025-10-23

Study results available
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Summary

The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine.

The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.

Conditions

Interventions

BIOLOGICAL

CV0701 mRNA COVID-19 Vaccine (Low dose)

Study vaccine was administered as a single intramuscular injection.

BIOLOGICAL

CV0701 mRNA COVID-19 Vaccine (Medium dose)

Study vaccine was administered as a single intramuscular injection.

BIOLOGICAL

CV0701 mRNA COVID-19 Vaccine (High dose)

Study vaccine was administered as a single intramuscular injection.

BIOLOGICAL

CV0601 mRNA COVID-19 Vaccine

Study vaccine was administered as a single intramuscular injection.

BIOLOGICAL

Control vaccine

Study vaccine was administered as a single intramuscular injection.

BIOLOGICAL

CV0801 mRNA COVID-19 Vaccine

Study vaccine was administered as a single intramuscular injection.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-08-30
Completion
2024-08-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05960097 on ClinicalTrials.gov