Table 1 Study objectives, outcomes and endpoints
Objectives | Outcome / Endpoint |
|---|---|
Primary | |
Determine if vaccination with 4CMenB reduces the incidence of gonorrhoea | Number of N. gonorrhoeae infections at any anatomical site over 2 years, diagnosed by nucleic acid amplification test (NAAT). |
Secondary | |
Characterise humoral immune response in 4CMenB-vaccinated serum | Level and function of N. gonorrhoeae-specific antibodies. |
Determine the safety and tolerability of 4CMenB in GBM aged 18–50 years | Number of SAEs reported where the cause has been determined to be related to the study treatment |
Determine the uptake and feasibility of 4CMenB as a preventative strategy for gonorrhoea in GBM attending sexual health services | Number of participants consented to the trial compared to number of participants where pre-screening was performed |