Table 2.
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.
All participants in the randomized set who received any study vaccination.
Number of participants randomized and exposed to study vaccination.
Number of participants in each treatment group reporting the event.