Trials / Unknown
UnknownNCT06175494
A Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Booster Vaccination With Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Booster Vaccination With Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) for the Prevention of SARS-CoV-2 Infection in a Population of 18 Years of Age and Older.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4,800 (estimated)
- Sponsor
- WestVac Biopharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVac Biopharma Co., Ltd. is a monovalent modified vaccine designed against Omicron XBB.1.5. This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical study with two cohorts, i.e. the immuno-bridging observational cohort and the efficacy observational cohort, aims to evaluate the efficacy, safety, and immunogenicity of booster vaccination with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) for the prevention of SARS-CoV-2 infection in a population of 18 years of age and older.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) | boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) |
| BIOLOGICAL | Recombinant COVID-19 Variant Vaccine (Sf9 Cell) | boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell) |
| BIOLOGICAL | Placebo | boost with saline |
Timeline
- Start date
- 2023-12-19
- Primary completion
- 2024-07-31
- Completion
- 2025-01-31
- First posted
- 2023-12-19
- Last updated
- 2024-04-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06175494. Inclusion in this directory is not an endorsement.