Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT05630859 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,009 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1582% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
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 |
What the finished NCT05630859 record still lists
NCT05630859 is an interventional study that assigns participants to a tested intervention. Its 1,009 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1582% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05630859 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05630859's enrollment target sits among peer trials
1,009 6th of 2000 higher than 1,995 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07191782 · 1,008 participants · NA
Examining the Efficacy of the PRAISE With Coaching Program
- NCT04389632 · 1,006 participants · Phase 1
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
- NCT06146738 · 1,015 participants
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
- NCT06608823 · 1,016 participants · NA
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI