drugset / Trial / NCT05501522
Immunogenicity and Safety Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted with AS03 in Adults Aged 18 Years and Older
Phase 3
Completed
840 enrolled
SK Bioscience Co., Ltd.
Coalition for Epidemic Preparedness Innovations · collabGlaxoSmithKline · collabInternational Vaccine Institute · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a Phase III, randomized, placebo-controlled, observer-blinded, parallel-group, multi-center study to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.
Timeline
- Start
- 2022-12-09
- Primary completion
- 2023-08-22
- Completion
- 2024-08-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GBP510 | Vaccine | 0.5 ml | — |