An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study protocol

Table 2 Study Schema

Month	0 *	3 *	6 *	9*	12 *	15 *	18 *	21 *	24 *	Un-scheduled
Eligibility	√
Consent	√
Randomisation	√
Vaccination	√	√
Physical examination (BP, temp)	√	√
Risk Assessment *	√	√	√	√	√	√	√	√	√	√
Sexual health & blood-borne virus test and results *	√	√	√	√	√	√	√	√	√	√
Research blood sample	√	√	√		√				√
Safety assessment for adverse events	√	√	√	√	√	√	√	√	√	√

*indicates standard of care visits and procedures for participants currently taking PrEP. Study tests and procedures which have been taken within 14 days of the study visit that have already been taken as standard of care for the patient, can be used for study and do not need to be repeated.

ISSN: 1471-2458