Trials / Completed
CompletedNCT05501522
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
A Phase III, Placebo-controlled, Randomized, Observer-blinded, Multi-national, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) Adjuvanted with AS03 in Adults Aged 18 Years and Older
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 840 (actual)
- Sponsor
- SK Bioscience Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GBP510 adjuvanted with AS03 | injection volume of 0.5mL on Day 0 |
| OTHER | Placebo (Normal Saline) | injection volume of 0.5mL on Day 0 |
Timeline
- Start date
- 2022-12-09
- Primary completion
- 2023-08-22
- Completion
- 2024-08-17
- First posted
- 2022-08-15
- Last updated
- 2024-10-16
Locations
4 sites across 2 countries: Colombia, Nepal
Source: ClinicalTrials.gov record NCT05501522. Inclusion in this directory is not an endorsement.