Local and Systemic Adverse Events After Injection of the First, Second, and Third Doses Among Participants Who Received Vaccine or Placebo
Fatigue
ADVERSE EVENTS
AEs indicates adverse events; RR, risk ratio.Systemic solicited AEs were more common in the vaccine group than in the placebo group after the first dose (5585 [29.3%] vs 1211 [25.5%]), second dose (4427 [24.4%]) vs 977 [21.7%]), and third dose (739 [17.7%] vs 148 [14.1%]). Fatigue was the most common systemic AE in both the vaccine (dose 1: 2380 [12.5%], dose 2: 1971 [10.9%], and dose 3: 299 [7.2%]) and placebo (dose 1: 492 [10.4%], dose 2: 411 [9.1%], and dose 3: 62 [5.9%]) groups (Unsolicited AEs within 3 days after the injection were comparable among participants in the vaccine and placebo groups after the first (1696 [8.9%] vs 458 [9.6%]) and second (1324 [7.3%] vs 334 [7.4%]) doses. However, in cohort 2, after the injection of FINLAY-FR-1A, there was a significant difference between the vaccine and placebo groups (330 [7.9%] vs 55 [5.2%]) (Overall, 23 serious AEs (19 [0.1%] in the vaccine group and 4 [<0.1%] in the placebo group) were reported, none of which were associated with the vaccine (eTable 7 in 