Trials / Completed
CompletedNCT05907044
A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults
An Interventional, Randomized, Parallel Controlled, Investigator Initiated Study to Investigate the Safety, Immunogenicity of Bivalent RQ3027 and RQ3025 mRNA Vaccine as a Booster Dose in 3 Doses COVID-19 Vaccine-Experienced Healthy Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 376 (actual)
- Sponsor
- Affiliated Hospital of Yunnan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RQ3013 | 0.15mL/dose containing mRNA 30μg |
| BIOLOGICAL | RQ3025 | 0.15mL/dose containing mRNA 30μg |
| BIOLOGICAL | RQ3027 | 0.15mL/dose containing mRNA 30μg |
Timeline
- Start date
- 2023-05-08
- Primary completion
- 2023-06-10
- Completion
- 2023-11-23
- First posted
- 2023-06-18
- Last updated
- 2024-01-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05907044. Inclusion in this directory is not an endorsement.