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. 2022 May 1;9(7):ofac206. doi: 10.1093/ofid/ofac206

Table 2.

Unsolicited Treatment-Related Adverse Events (Exposed Set a )

Placebo (n = 30)b mRNA-1653 Combined (n = 94)b
25 μg 75 μg 150 μg 300 μg
2-Dose (n = 4)b 1-Dose (n = 13)b 2-Dose (n = 17)b 1-Dose (n = 13)b 2-Dose (n = 17)b 1-Dose (n = 13)b 2-Dose (n = 17)b
No. (%)c
 All unsolicited AEs 0 0 0 1 (5.9) 1 (7.7) 3 (17.6) 3 (23.1) 3 (17.6) 11 (11.7)
 SAEs 0 0 0 0 0 0 0 0 0
 Fatal AEs 0 0 0 0 0 0 0 0 0
 AEs leading to withdrawal 0 0 0 0 0 0 0 0 0
 AEs grade 3+ 0 0 0 0 0 0 1 (7.7) 2 (11.8) 3 (3.2)
 AESIs 0 0 0 0 0 0 0 0 0
 MAEs 0 0 0 0 0 0 2 (15.4) 3 (17.6) 5 (5.3)

Abbreviations: AE, adverse event; AESI, adverse event of special interest; MAE, medically attended adverse event; SAE, serious adverse event.

a

All participants in the randomized set who received any study vaccination.

b

Number of participants randomized and exposed to study vaccination.

c

Number of participants in each treatment group reporting the event.