Table 2.
mRNA-1283 |
mRNA-1273 | ||||
---|---|---|---|---|---|
n (%) | 10 µg (n = 21) |
30 µg (n = 22) |
100 µg (n = 21) |
Placebo + 100 µg (n = 18) |
100 µg (n = 22) |
All unsolicited TEAEs | |||||
All AEs | 8 (38.1) | 9 (40.9) | 9 (42.9) | 4 (22.2) | 7 (31.8) |
SAEs | 0 | 0 | 0 | 0 | 0 |
Fatal AEs | 0 | 0 | 0 | 0 | 0 |
MAAEs | 3 (14.3) | 2 (9.1) | 2 (9.5) | 2 (11.1) | 3 (13.6) |
AEs leading to vaccination discontinuation | 0 | 0 | 0 | 0 | 1 (4.5) |
AEs leading to study discontinuation | 0 | 0 | 0 | 0 | 0 |
Severe | 0 | 0 | 0 | 0 | 0 |
AESIs | 0 | 0 | 0 | 0 | 0 |
Related unsolicited TEAEs | |||||
All AEs | 2 (9.5) | 4 (18.2) | 4 (19.0) | 2 (11.1) | 4 (18.2) |
SAEs | 0 | 0 | 0 | 0 | 0 |
Fatal AEs | 0 | 0 | 0 | 0 | 0 |
MAAEs | 0 | 1 (4.5) | 1 (4.8) | 0 | 1 (4.5) |
AEs leading to vaccination discontinuation | 0 | 0 | 0 | 0 | 1 (4.5) |
AEs leading to study discontinuation | 0 | 0 | 0 | 0 | 0 |
Severe | 0 | 0 | 0 | 0 | 0 |
AESIs | 0 | 0 | 0 | 0 | 0 |
A TEAE is any event not present before exposure to study vaccination or any event already present that worsened in intensity or frequency after exposure.
Abbreviations: AE, adverse event; AESI, adverse event of special interest; MAAE, medically attended adverse event; mRNA, messenger RNA; SAE, serious adverse event; TEAE, treatment-emergent adverse event.