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A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults

NCT05907044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2024-01-24

No results posted yet for this study

Summary

This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are:

* The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant.
* The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age.
* Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.

Conditions

Interventions

BIOLOGICAL

RQ3013

0.15mL/dose containing mRNA 30μg

BIOLOGICAL

RQ3025

0.15mL/dose containing mRNA 30μg

BIOLOGICAL

RQ3027

0.15mL/dose containing mRNA 30μg

Sponsors & Collaborators

  • Yunnan University

    collaborator UNKNOWN

  • Kunming Medical University

    collaborator OTHER

  • Affiliated Hospital of Yunnan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2023-06-10
Completion
2023-11-23

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 NCT05907044 on ClinicalTrials.gov