drugset / Trial / NCT04062669
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults
RandomizedSequentialQuadruple-blindPrevention
Summary
The purpose of this first time-in-human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of different dose levels of an experimental rabies glycoprotein G (RG) vaccine (RG-SAM \[CNE\] vaccine), made using a new technology, when administered intramuscularly (IM) on a 0, 2, 6 \*-month schedule to healthy adults. \* There will be no vaccinations with the third dose of any of the study treatments.
Timeline
- Start
- 2019-08-13
- Primary completion
- 2021-07-28
- Completion
- 2022-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK3903133A | Vaccine | — | Intramuscular |
| Comparator | Rabies vaccine | Vaccine | — | Intramuscular |