Full name
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
NCT Number
NCT05630859
Geography
US
Non-US
Locations
Brazil, France, Germany, Philippines, South Africa, Spain, United Kingdom, United States
Primary Endpoints
- Percentage of participants reporting solicited administration site events in study Phase 1 (Dose-escalation safety lead-in). 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). 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). 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). 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). 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). 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). 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). 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). 7 days after the first dose
- Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 1 (Dose-escalation safety lead-in). 7 days after the second dose
- Incidence rates of confirmed gonorrhea cases in study Phase 2 [Efficacy Proof of Concept (PoC)]. From 1 month to 13 months post-Dose 2
- Percentage of participants reporting solicited administration site events in study Phase 2 (Efficacy PoC). 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). 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). 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). During the 7 days follow-up period after the second dose
- Percentage of participants reporting unsolicited AEs in study Phase 2 (Efficacy PoC). During the 30 days follow-up period after the first dose
- Percentage of participants reporting unsolicited AEs in study Phase 2 (Efficacy PoC). During the 30 days follow-up period after the second dose
- Percentage of participants reporting SAEs in study Phase 2 (Efficacy PoC). 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). 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). 7 days after the first dose
- Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 2 (Efficacy PoC). 7 days after the second dose
External Link
https://clinicaltrials.gov/study/NCT05630859
Order
6
Disease
Version
Phase
1/2