Trials / Completed
CompletedNCT05007951
Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19)
A 2-Stage, Phase III, Randomized, Active-controlled, Observer-blind, Parallel-group, Multi-center Study to Assess the Immunogenicity and Safety of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine Adjuvanted With AS03 (GBP510) in Adults Aged 18 Years and Older
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4,036 (actual)
- Sponsor
- SK Bioscience Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a 2-Stage, Phase III, randomized, active-controlled, observer-blind, parallel-group, multi-center study to compare the immunogenicity and safety of SK SARS-CoV-2 recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) to ChAdOx1-S in adults aged 18 years and older.
Detailed description
The purpose of this study is to assess the immunogenicity and safety of SK SARS-CoV-2 recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) in adults aged 18 years and older. This study includes 2-dose schedule (28-day interval) of GBP510(Test vaccine) and ChAdOx1-S(Control vaccine) in stage1. Participants are expected to participate for up to a maximum of approximately 13 months. A 12-month study follow-up after the 2nd vaccination will be conducted. One booster dose of GBP510 is scheduled for both test group and control group in Stage2. A 12-month study follow-up after the 3rd vaccination will be conducted. International Vaccine Institute (IVI) conducts GBP510\_003 trial as co-sponsor with SK bioscience.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) | injection volume of 0.5mL on days 0 and 28 (stage1) |
| BIOLOGICAL | ChAdOx1-S not less than 2.5 × 10^8 infectious units | injection volume of 0.5mL on days 0 and 28 (stage1) |
| BIOLOGICAL | GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) | injection volume of 0.5mL on days 0 (stage2) |
Timeline
- Start date
- 2021-08-30
- Primary completion
- 2023-10-02
- Completion
- 2023-10-02
- First posted
- 2021-08-17
- Last updated
- 2024-04-08
Locations
38 sites across 6 countries: New Zealand, Philippines, South Korea, Thailand, Ukraine, Vietnam
Source: ClinicalTrials.gov record NCT05007951. Inclusion in this directory is not an endorsement.