Follow-up of AEs
loose, nausea, fever, vomiting, ache
ADVERSE EVENTS
The AE reporting period began upon receipt of the first dose of vaccine/placebo and ended the day the participant travelled to Benin (or at participant’s withdrawal, whichever came first). Ongoing AEs were followed until resolution, the last study visit V5 or participant’s withdrawal, whichever came first. Any trial procedure-related AEs recorded between enrolment and first dose of vaccination or serious adverse events (SAEs) occurring at any time of the study were also reported.The participants reported solicited and unsolicited AEs for 5 days after each dose on AEF1 and AEF2 forms (active surveillance). Solicited AEs included fever, loose stools/diarrhoea, nausea, stomach ache and vomiting. For the severity grading (mild, moderate and severe) of solicited AEs, see The relation between AE and vaccine/placebo was categorized as probable, possible or unlikely according to the World Health Organization and Uppsala Monitoring Centre definitions.Participants with solicited AEs (ITT population, 



