Fig. 4

Percentages of participants (with exact 95% confidence intervals) reporting solicited local (pain, redness and swelling) and general (fatigue, gastrointestinal symptoms, headache, myalgia, chills and fever) adverse events (any intensity and grade 3 intensity) during the 7-day period after each injection and overall per participant (total vaccinated cohort). Injections 1 and 2, vaccine doses in both groups; injection 3, vaccine dose in 0–2–6 group, placebo in 0–2–12 group; injection 4, placebo in 0–2–6 group, vaccine dose in 0–2–12 group. GI (gastrointestinal) symptoms defined as nausea, vomiting, diarrhoea and/or abdominal pain. Fever defined as temperature ≥ 37.5 °C. Grade 3 intensity defined as redness or swelling of diameter > 100 mm, temperature ≥ 39 °C and, for all other adverse events, prevention of normal activities. Number of participants: 100, 92, 89 and 84 post-injection 1, 2, 3 and 4, respectively, for 0–2–6 group; 100, 97, 97, 93, respectively, for 0–2–12 group