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).
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Timeframe: From Day 1 to Day 7
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Timeframe: From Day 61 to Day 67
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Timeframe: From Day 1 to Day 7
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Timeframe: From Day 61 to Day 67
Phase 1: Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
Timeframe: From Day 1 to Day 30
Phase 1: Number of Participants Reporting Any Unsolicited AEs
Timeframe: From Day 61 to Day 90
Phase 1: Number of Participants Reporting Any Serious Adverse Events (SAEs) and AEs Leading to Withdrawal
Timeframe: From Day 1 after the first dose to Day 241
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
Timeframe: At Day 8 compared to baseline (Day 1)
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
Timeframe: At Day 68 compared to baseline (Day 61)
Phase 2: Incidence Rate of Confirmed Gonorrhea Cases
Timeframe: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Timeframe: From Day 1 to Day 7
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Timeframe: From Day 61 to Day 67
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Timeframe: From Day 1 to Day 7
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Timeframe: From Day 61 to Day 67
Phase 2: Number of Participants Reporting Any Unsolicited AEs
Timeframe: From Day 1 to Day 30
Phase 2: Number of Participants Reporting Any Unsolicited AEs
Timeframe: From Day 61 to Day 90
Phase 2: Number of Participants Reporting Any SAEs and AEs Leading to Withdrawal
Timeframe: From Day 1 after the first dose to Day 451
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values in HIV Negative (HIV-) Subset
Timeframe: At Day 8 compared to baseline (Day 1)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV Positive (HIV+) Subset
Timeframe: At Day 8 compared to baseline (Day 1)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV- Subset
Timeframe: At Day 68 compared to baseline (Day 61)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values HIV+ Subset
Timeframe: At Day 68 compared to baseline (Day 61)