Table 5.
Solicited and Unsolicited Adverse Events After a Second RSVPreF3 OA Dose or Placebo
| Adverse Event | RSV_revaccination | RSV_1dose | Placebo | |||
|---|---|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| Dose 2–solicited safety population | N = 327 | N = 345 | N = 667 | |||
| Solicited AEs (within 4 d post–dose 2) | ||||||
| Any solicited AE | 208 | 63.6 (58.1, 68.8) | 91 | 26.4 (21.8, 31.4) | 147 | 22.0 (18.9, 25.4) |
| Grade 3 | 15 | 4.6 (2.6, 7.5) | 3 | 0.9 (.2, 2.5) | 10 | 1.5 (.7, 2.7) |
| Solicited administration-site AE | 177 | 54.1 (48.6, 59.6) | 33 | 9.6 (6.7, 13.2) | 51 | 7.6 (5.7, 9.9) |
| Grade 3 | *10* | … | *10* | … | *10* | … |
| Solicited systemic AE | 146 | 44.6 (39.2, 50.2) | 74 | 21.4 (17.2, 26.2) | 121 | 18.1 (15.3, 21.3) |
| Grade 3 | 6 | 1.8 (.7, 4.0) | 3 | 0.9 (.2, 2.5) | 10 | 1.5 (.7, 2.7) |
| Unsolicited AEs (within 30 d post-dose 2) | ||||||
| Any unsolicited AE | 51 | 15.6 (11.8, 20.0) | 36 | 10.4 (7.4, 14.2) | 71 | 10.6 (8.4, 13.2) |
| Grade 3 | 9 | 2.8 (1.3, 5.2) | 7 | 2.0 (.8, 4.1) | 9 | 1.3 (.6, 2.5) |
| Dose 2–exposed population | N = 4966 | N = 4991 | N = 10 033 | |||
| Unsolicited AEs (within 30 d post–dose 2)a | ||||||
| Any unsolicited AE | 1416 | 28.5 (27.3, 29.8) | 791 | 15.8 (14.8, 16.9) | 1495 | 14.9 (14.2, 15.6) |
| Grade 3 | 107 | 2.2 (1.8, 2.6) | 54 | 1.1 (.8, 1.4) | 120 | 1.2 (1.0, 1.4) |
| Any related unsolicited AE | 947 | 19.1 (18.0, 20.2) | 215 | 4.3 (3.8, 4.9) | 326 | 3.2 (2.9, 3.6) |
| Grade 3 | 56 | 1.1 (.9, 1.5) | 7 | 0.1 (.1, .3) | 12 | 0.1 (.1, .2) |
| Any medically attended unsolicited AE | 337 | 6.8 (6.1, 7.5) | 306 | 6.1 (5.5, 6.8) | 630 | 6.3 (5.8, 6.8) |
| Serious AEs and potential immune-mediated diseases (within 6 mo post–dose 2) | ||||||
| Any serious AE | 210 | 4.2 (3.7, 4.8) | 219 | 4.4 (3.8, 5.0) | 461 | 4.6 (4.2, 5.0) |
| Any potential immune-mediated disease | 14 | 0.3 (.2, .5) | 19 | 0.4 (.2, .6) | 35 | 0.3 (.2, .5) |
| Serious AEs and potential immune-mediated diseases (from dose 2 up to data lock point) | ||||||
| Any related serious AEb | 4 | 0.1 (.0, .2) | 2 | 0.0 (.0, .1) | 4 | 0.0 (.0, .1) |
| Any related potential immune-mediated diseaseb | 1 | 0.0 (.0, .1) | 1 | 0.0 (.0, .1) | 2 | 0.0 (.0, .1) |
| Any fatal serious AE | 20 | 0.4 (.2, .6) | 26 | 0.5 (.3, .8) | 41 | 0.4 (.3, .6) |
“Grade 3” was defined as diameter >100 mm for erythema and swelling, temperature >39.0°C for fever, preventing normal everyday activities for all other events; “related” indicates considered related to vaccine/placebo administration by investigator assessment.
Abbreviations: AE, adverse event; CI, confidence interval; n/%, number/percentage of participants reporting the event at least once (numbers between asterisks, eg, *10, * indicate that data by group are blinded to avoid participant-level unblinding of the study team; the number between the asterisks shows the total number across the 3 groups); N, number of participants in the indicated analysis population; placebo, group of participants who received placebo pre–season 1 and pre–season 2; RSV, respiratory syncytial virus; RSV_1dose, group of participants who received a single RSV prefusion F protein–based vaccine (RSVPreF3 OA) dose pre–season 1 and a placebo dose pre–season 2; RSV_revaccination, group of participants who received a first dose of RSVPreF3 OA pre–season 1 and a second RSVPreF3 OA dose (revaccination) pre–season 2.
aMost unsolicited adverse events in the RSV_revaccination group were reactogenicity events, primarily in participants who were not included in the reactogenicity-immunogenicity cohort and thus reported reactogenicity events as unsolicited AEs.
bRelated serious AEs and potential immune-mediated disease are detailed in the Supplementary Results.