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Pain at the injection site was the most frequently reported solicited local symptom.
The most frequently reported solicited symptom was mild drowsiness, reported in all three vaccine groups.
Safety was analyzed in participants who received at least one vaccination and reported solicited or unsolicited adverse events.
Fever was the most frequently reported solicited general symptom, occurring with a similar incidence in both the RTS,S/AS02D and RTS,S/AS01E vaccine groups and in both the 0,1,2-month (overall/dose: 39.1% vs 35.9%, respectively [rabies 11.2%]) and the 0,1,7-month (47.9% vs 46.8%, respectively) schedules (Figure 2).
Vomiting was the least reported solicited AE in all groups.
For the 30 subjects who underwent at least one vaccination, 26 (86.7%) reported solicited local symptoms and 13 (43.3%) reported solicited systemic symptoms within 7 days after vaccination.
In both groups, the most frequently reported solicited general symptom following each vaccine dose was irritability.
Swelling was the most frequently reported solicited local symptom (47.5% of subjects).
Similar(3)
In general, H1N1 LAIV recipients reported more solicited symptoms compared with placebo recipients.
Fatigue, headache and myalgia were the most frequently reported systemic solicited symptoms in the three groups.
None of the subjects reported any solicited local adverse events of Grade 3 intensity.
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