Trials / Unknown
UnknownNCT05396573
A Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19
A Randomized, Blinded, Positive Control Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine (RQ3013) in Healthy Adults Completed a Two-dose Primary Series of Inactivated Vaccine
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Walvax Biotechnology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months earlier. The study vaccine is administered IM in the upper arm deltoid as single booster shot on day 0.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RQ3013 | A single dose of 30 μg/0.15 mL, a single dose of 60 μg/0.3 mL |
| BIOLOGICAL | Comirnaty | A single dose of 30 μg/0.3 mL |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2022-08-01
- Completion
- 2023-07-01
- First posted
- 2022-05-31
- Last updated
- 2022-05-31
Source: ClinicalTrials.gov record NCT05396573. Inclusion in this directory is not an endorsement.