Solicited AEs
stomach ache, loose stools/diarrhoea, nausea, vomiting
The number of participants reporting at least one solicited AE was 170/374 (45.5%) amongst those given vaccine and 159/375 (42.4%) amongst those receiving placebo, with loose stools/diarrhoea (26.7/25.9%) and stomach ache (23.0/20.0%) as the most frequent symptoms, respectively; the vast majority of AEs were reported as mild (As for the timing of AEs in the active group, nausea was mostly reported on the day of vaccine administration: 23 (6.1%) had nausea after the first vaccine dose and 28 (7.5%) after the second. Most vomiting episodes in the active group (nine participants) occurred on the day of the second vaccine dose.