Trials / Completed
CompletedNCT05630859
Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age.
A Phase 1/2, Observer-blind, Randomized, Placebo-controlled Multi-country Study to Assess Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 1,004 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The aim of this first time in human proof of concept (FTiH-PoC) study is to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | NgG low dose investigational vaccine | Two doses of NgG low dose investigational vaccine, administered intramuscularly. |
| BIOLOGICAL | NgG medium dose investigational vaccine | Two doses of NgG medium dose investigational vaccine, administered intramuscularly. |
| BIOLOGICAL | NgG high dose investigational vaccine | Two doses of NgG high dose investigational vaccine, administered intramuscularly. |
| BIOLOGICAL | Placebo | Two doses of placebo, administered intramuscularly. |
| BIOLOGICAL | NgG HTD investigational vaccine | Two doses of NgG HTD investigational vaccine, administered intramuscularly. |
| BIOLOGICAL | NgG below HTD investigational vaccine | Two doses of NgG below HTD investigational vaccine, administered intramuscularly. |
Timeline
- Start date
- 2022-11-28
- Primary completion
- 2025-05-22
- Completion
- 2025-05-22
- First posted
- 2022-11-30
- Last updated
- 2025-08-07
Locations
23 sites across 8 countries: United States, Brazil, France, Germany, Philippines, South Africa, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05630859. Inclusion in this directory is not an endorsement.