Table 3.
Unsolicited Adverse Events, Serious Adverse Events, and Potential Immune-Mediated Diseases After RSVPreF3 OA or Placebo Administration (Exposed Population)
| Adverse Event | 50–59-non-AIR-RSV (N = 383) | 50–59-non-AIR-placebo (N = 192) | 50–59-AIR-RSV (N = 386) | 50–59-AIR-placebo (N = 191) | ≥60-RSV (N = 381) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| Unsolicited AEs within 30 days | ||||||||||
| Any | 50 | 13.1 (9.8, 16.8) | 26 | 13.5 (9.0, 19.2) | 56 | 14.5 (11.1, 18.4) | 20 | 10.5 (6.5, 15.7) | 62 | 16.3 (12.7, 20.4) |
| Grade 3 | 4 | 1.0 (.3, 2.7) | 0 | 0.0 (.0, 1.9) | 4 | 1.0 (.3, 2.6) | 4 | 2.1 (.6, 5.3) | 2 | .5 (.1, 1.9) |
| Related | 14 | 3.7 (2.0, 6.1) | 5 | 2.6 (.9, 6.0) | 12 | 3.1 (1.6, 5.4) | 3 | 1.6 (.3, 4.5) | 12 | 3.1 (1.6, 5.4) |
| Grade 3 related | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 1 | .3 (.0, 1.5) |
| Medically attended | 12 | 3.1 (1.6, 5.4) | 10 | 5.2 (2.5, 9.4) | 24 | 6.2 (4.0, 9.1) | 13 | 6.8 (3.7, 11.4) | 27 | 7.1 (4.7, 10.1) |
| SAEs and pIMDs within 6 months | ||||||||||
| Any SAE | 2 | .5 (.1, 1.9) | 4 | 2.1 (.6, 5.2) | 14 | 3.6 (2.0, 6.0) | 4 | 2.1 (.6, 5.3) | 9 | 2.4 (1.1, 4.4) |
| Any pIMDa | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 4 | 1.0 (.3, 2.6) | 1 | .5 (.0, 2.9) | 3 | .8 (.2, 2.3) |
| Related or fatal SAEs and related pIMDs until data lock point | ||||||||||
| Related SAE | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 1 | 0.3 (.0, 1.5) |
| Fatal SAE | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 0 | 0.0 (.0, 1.0) |
| Related pIMD | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 0 | 0.0 (.0, 1.0) | 0 | 0.0 (.0, 1.9) | 1 | 0.3 (.0, 1.5) |
A grade 3 adverse event (AE) is an AE that prevents normal activity.
Abbreviations: CI, confidence interval; N, number of participants in the exposed population; n (%), number (percentage) of participants in the indicated category; pIMD, potential immune-mediated disease; SAE, serious adverse event; 50–59-AIR-RSV, group of 50–59-year-old participants at increased risk for respiratory syncytial virus (RSV) disease who received RSV prefusion F protein–based vaccine (RSVPreF3 OA); 50–59-non-AIR-RSV, group of 50–59-year-old participants without increased risk for RSV disease who received RSVPreF3 OA; ≥60-RSV, group of ≥60-year-old participants who received RSVPreF3 OA.
aReported pIMDs were new-onset pericarditis, new-onset spondylitis, worsening of pre-existing gouty arthritis, and worsening of pre-existing gout in the 50–59-AIR-RSV group, pericarditis in the 50–59-AIR-placebo group, and new-onset cold-type hemolytic anemia, new-onset polymyalgia rheumatica, and worsening of pre-existing psoriasis in the ≥60-RSV group.