drugset / Trial / NCT05561673
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
RandomizedParallel-groupOpen-labelPrevention
Summary
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from other approved adjuvant systems and from an aluminum-based adjuvant.
Timeline
- Start
- 2022-10-04
- Primary completion
- 2024-11-29
- Completion
- 2024-11-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AS03 | Other / unclassified | — | Intramuscular |
| Subject | AS04 | Unknown | — | Intramuscular |
| Subject | AS37A | Unknown | 100 ug | Intramuscular |
| Subject | AS37B | Unknown | 50 ug | Intramuscular |
| Subject | GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg) | Vaccine | 20 ug | Intramuscular |
| Subject | GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg) | Vaccine | 20 ug | Intramuscular |
| Subject | HBsAg candidate vaccine | Vaccine | — | Intramuscular |
| Subject | Hepatitis B vaccine | Vaccine | — | Intramuscular |
| Background | Aluminum hydroxide | Unknown | — | Intramuscular |