Sexual and Reproductive Health
A multi-country Phase 1/2 trial, conducted in an observer-blind, randomized, and placebo-controlled manner, aiming to evaluate the safety and efficacy of the GSK Neisseria gonorrhoeae GMMA (NgG) investigational vaccine in healthy adults aged 18 to 50 (NGG-001)
Rationale
- To ascertain the effectiveness of the NgG vaccine in preventing cases of gonorrhoea.
- To assess the safety and reactogenicity of the NgG vaccine post-administration.
- Measure the incidence rates of confirmed gonorrhoea cases from 1 month (Day 91) to 13 months post-Dose 2 (Day 451).
- Record the number and percentage of participants reporting each solicited administration site event during the 7-day follow-up period after each dose (Day 1 and Day 61).
- Document the number and percentage of participants reporting each solicited systemic event during the 7-day follow-up period after each dose (Day 1 and Day 61).
- Track the number and percentage of participants reporting unsolicited Adverse Events (AEs) during the 30-day follow-up period after each dose (Day 1 and Day 61).
- Monitor the number and percentage of participants reporting Serious Adverse Events (SAEs) from Day 1 after the first dose until the study concludes (Day 451).
- Document the number and percentage of participants reporting AEs leading to withdrawal from Day 1 after the first dose until the study concludes (Day 451). Analyze the number and percentage of participants with hematological and biochemical laboratory abnormalities, comparing values to baseline (Screening and Day 61), at Day 8 and Day 68, respectively.
