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).
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Percentage of participants reporting solicited administration site events in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: During the 7 days follow-up period after the first dose
Percentage of participants reporting solicited administration site events in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: During the 7 days follow-up period after the second dose
Percentage of participants reporting each solicited systemic event in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: During the 7 days follow-up period after the first dose
Percentage of participants reporting each solicited systemic event in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: During the 7 days follow-up period after the second dose
Percentage of participants reporting unsolicited adverse events (AEs) in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: During the 30 days follow-up period after the first dose
Percentage of participants reporting unsolicited AEs in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: During the 30 days follow-up period after the second dose
Percentage of participants reporting serious adverse events (SAEs) in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: From Day 1 after the first dose up to study Phase I end (Day 241)
Percentage of participants reporting AEs leading to withdrawal in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: From Day 1 after the first dose up to study Phase I end (Day 241)
Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: 7 days after the first dose
Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 1 (Dose-escalation safety lead-in)
Timeframe: 7 days after the second dose
Incidence rates of confirmed gonorrhea cases in study Phase 2 [Efficacy Proof of Concept (PoC)]
Timeframe: From 1 month to 13 months post-Dose 2
Percentage of participants reporting solicited administration site events in study Phase 2 (Efficacy PoC)
Timeframe: During the 7 days follow-up period after the first dose
Percentage of participants reporting solicited administration site events in study Phase 2 (Efficacy PoC)
Timeframe: During the 7 days follow-up period after the second dose
Percentage of participants reporting each solicited systemic event in study Phase 2 (Efficacy PoC)
Timeframe: During the 7 days follow-up period after the first dose
Percentage of participants reporting each solicited systemic event in study Phase 2 (Efficacy PoC)
Timeframe: During the 7 days follow-up period after the second dose
Percentage of participants reporting unsolicited AEs in study Phase 2 (Efficacy PoC)
Timeframe: During the 30 days follow-up period after the first dose
Percentage of participants reporting unsolicited AEs in study Phase 2 (Efficacy PoC)
Timeframe: During the 30 days follow-up period after the second dose
Percentage of participants reporting SAEs in study Phase 2 (Efficacy PoC)
Timeframe: From Day 1 after the first dose up to study end (Day 451)
Percentage of participants reporting AEs leading to withdrawal in study Phase 2 (Efficacy PoC)
Timeframe: From Day 1 after the first dose up to study end (Day 451)
Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 2 (Efficacy PoC)
Timeframe: 7 days after the first dose
Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 2 (Efficacy PoC)
Timeframe: 7 days after the second dose