Trials / Completed
CompletedNCT04062669
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults
Safety and Immunogenicity of GSK's Rabies G SAM (CNE) Vaccine [GSK3903133A] in Healthy Adults.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A) | Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) low dose formulation, administered intramuscularlyat Days 1 and 61. |
| BIOLOGICAL | Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A) | Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 1 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly at Day 1. |
| BIOLOGICAL | Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A) | Subjects in the Lower dose (Lrd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lower dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61) |
| BIOLOGICAL | Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A) | Subjects in the Lowest dose (Ltd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lowest dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61) |
| DRUG | Saline Placebo | Subjects in the Saline Placebo group will receive 2 doses of saline Placebo, administered intramuscularly Day 1 and 61. |
| BIOLOGICAL | RabAvert | Subjects in the RabAvert Group will receive 2 doses of RabAvert vaccine, administered intramuscularly, at Days 1 and 61. |
Timeline
- Start date
- 2019-08-13
- Primary completion
- 2021-07-28
- Completion
- 2022-07-01
- First posted
- 2019-08-20
- Last updated
- 2024-03-01
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04062669. Inclusion in this directory is not an endorsement.