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NCT05630859 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,009
- Enrollment target
NCT05630859 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,009 participants.
The verdict
NCT05630859, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,009 participants
- Enrollment target
Study Summary
The aim of this first time in human proof of concept (FTiH-PoC) study was 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).
Interventions
- COMBINATION_PRODUCT Placebo
- BIOLOGICAL NgG 12.5 µg investigational vaccine
- BIOLOGICAL NgG 25 µg investigational vaccine
- BIOLOGICAL NgG 50 µg investigational vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,009 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2025-05-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05630859
The ClinicalTrials.gov registry entry for NCT05630859 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1,009 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05630859 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05630859 about?
NCT05630859 is a clinical study titled "Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age". The aim of this first time in human proof of concept (FTiH-PoC) study was 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 compa...
What is the current status of trial NCT05630859?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,009 participants. The study started on 2022-11-28. Estimated completion is 2025-05-22.
What interventions are being tested in trial NCT05630859?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), NgG 12.5 µg investigational vaccine (BIOLOGICAL), NgG 25 µg investigational vaccine (BIOLOGICAL), NgG 50 µg investigational vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05630859?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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