Table 2.
Percentages of Participants Reporting Adverse Events (Total Vaccinated Cohort)
| Adverse Events | RZV (N = 117) | Placebo (N = 115) | ||
|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | |
| Within 30 days after vaccination | ||||
| Unsolicited adverse events | ||||
| Any grade | 100 | 85.5 (77.8‐91.3) | 103 | 89.6 (82.5‐94.5) |
| Grade 3 | 18 | 15.4 (9.4‐23.2) | 15 | 13.0 (7.5‐20.6) |
| Any grade: related | 10 | 8.5 (4.2‐15.2) | 9 | 7.8 (3.6‐14.3) |
| Grade 3: related | 1 | 0.9 (0.0‐4.7) | 0 | 0.0 (0.0‐3.2) |
| MAEs | ||||
| All | 31 | 26.5 (18.8‐35.5) | 33 | 28.7 (20.6‐37.9) |
| First vaccination through 30 days after last vaccination | ||||
| pIMDs | ||||
| All | 0 | — | 0 | — |
| SAEs | ||||
| All | 16 | 13.7 (8.0‐21.3) | 14 | 12.2 (6.8‐19.6) |
| Related | 0 | — | 0 | — |
| 30 days after last vaccination through study end | ||||
| pIMDs | ||||
| All | 0 | 0.0 (0.0‐3.1) | 1 | 0.9 (0.0‐4.7) |
| SAEs | ||||
| All | 30 | 25.6 (18.0‐34.5) | 31 | 27.0 (19.1‐36.0) |
| Related | 0 | — | 0 | — |
| Entire study | ||||
| Fatal SAEs | 12 | 10.3 (5.4‐17.2) | 11 | 9.6 (4.9‐16.5) |
Abbreviations: CI, confidence interval; MAEs, adverse events with medically attended visits; N, total number of participants; n, number of participants with ≥1 documented (solicited adverse events) or administered (other adverse events) dose; pIMDs, potential immune‐mediated diseases; RZV, adjuvanted recombinant zoster vaccine; SAEs, serious adverse events.
Causal relationship to vaccination was assessed by the investigator.