Table 3.
Safety and reactogenicity (exposed set).
| RZV group |
Placebo group |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall |
50–69 years |
≥70 years |
Overall |
50–69 years |
≥70 years |
|||||||
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| Seven days post any vaccination | ||||||||||||
| N | 3054 | 2409 | 645 | 3058 | 2411 | 647 | ||||||
| Solicited AEs | 2329 | 76.3 (74.7–77.8) | 1920 | 79.7 (78.0–81.3) | 409 | 63.4 (59.6–67.1) | 439 | 14.4 (13.1–15.6) | 360 | 14.9 (13.5–16.4) | 79 | 12.2 (9.8–15.0) |
| Solicited local AEs | 2230 | 73.0 (71.4–74.6) | 1847 | 76.7 (74.9–78.3) | 383 | 59.4 (55.5–63.2) | 283 | 9.3 (8.3–10.3) | 236 | 9.8 (8.6–11.0) | 47 | 7.3 (5.4–9.5) |
| Solicited general AEs | 1675 | 54.8 (53.1–56.6) | 1440 | 59.8 (57.8–61.7) | 235 | 36.4 (32.7–40.3) | 261 | 8.5 (7.6–9.6) | 214 | 8.9 (7.8–10.1) | 47 | 7.3 (5.4–9.5) |
| 30 days post any vaccination | ||||||||||||
| N | 3064 | 2415 | 649 | 3064 | 2415 | 649 | ||||||
| Unsolicited AEs | 124 | 4.0 (3.4–4.8) | 96 | 4.0 (3.2–4.8) | 28 | 4.3 (2.9–6.2) | 97 | 3.2 (2.6–3.8) | 73 | 3.0 (2.4–3.8) | 24 | 3.7 (2.4–5.5) |
| Grade 3 | 8 | 0.3 (0.1–0.5) | 4 | 0.2 (0.0–0.4) | 4 | 0.6 (0.2–1.6) | 10 | 0.3 (0.2–0.6) | 7 | 0.3 (0.1–0.6) | 3 | 0.5 (0.1–1.3) |
| Medically attended | 64 | 2.1 (1.6–2.7) | 49 | 2.0 (1.5–2.7) | 15 | 2.3 (1.3–3.8) | 53 | 1.7 (1.3–2.3) | 37 | 1.5 (1.1–2.1) | 16 | 2.5 (1.4–4.0) |
| First vaccination up to 30 days post-last vaccination | ||||||||||||
| SAEs | 32 | 1.0 (0.7–1.5) | 20 | 0.8 (0.5–1.3) | 12 | 1.8 (1.0–3.2) | 36 | 1.2 (0.8–1.6) | 23 | 1.0 (0.6–1.4) | 13 | 2.0 (1.1–3.4) |
| Related SAEs | 0 | 0.0 (0.0–0.1) | 0 | 0.0 (0.0–0.2) | 0 | 0.0 (0.0–0.6) | 1 | 0.0 (0.0–0.2) | 1 | 0.0 (0.0–0.2) | 0 | 0.0 (0.0–0.6) |
| Deathsa | 3 | 0.1 (0.0–0.3) | 2 | 0.1 (0.0–0.3) | 1 | 0.2 (0.0–0.9) | 2 | 0.1 (0.0–0.2) | 1 | 0.0 (0.0–0.2) | 1 | 0.2 (0.0–0.9) |
| pIMDs | 2 | 0.1 (0.0–0.2) | 2 | 0.1 (0.0–0.3) | 0 | 0.0 (0.0–0.6) | 2 | 0.1 (0.0–0.2) | 2 | 0.1 (0.0–0.3) | 0 | 0.0 (0.0–0.6) |
| First vaccination up to 12 months post-last vaccination | ||||||||||||
| N | 3064 | 2415 | 649 | 3064 | 2415 | 649 | ||||||
| SAEs | 88 | 2.9 (2.3–3.5) | 55 | 2.3 (1.7–3.0) | 33 | 5.1 (3.5–7.1) | 93 | 3.0 (2.5–3.7) | 62 | 2.6 (2.0–3.3) | 31 | 4.8 (3.3–6.7) |
| Related SAEs | 0 | 0.0 (0.0–0.1) | 0 | 0.0 (0.0–0.2) | 0 | 0.0 (0.0–0.6) | 1 | 0.0 (0.0–0.2) | 1 | 0.0 (0.0–0.2) | 0 | 0.0 (0.0–0.6) |
| Deathsb | 11 | 0.4 (0.2–0.6) | 7 | 0.3 (0.1–0.6) | 4 | 0.6 (0.2–1.6) | 9 | 0.3 (0.1–0.6) | 5 | 0.2 (0.1–0.5) | 4 | 0.6 (0.2–1.6) |
| pIMDs | 2 | 0.1 (0.0–0.2) | 2 | 0.1 (0.0–0.3) | 0 | 0.0 (0.0–0.6) | 3 | 0.1 (0.0–0.3) | 3 | 0.1 (0.0–0.4) | 0 | 0.0 (0.0–0.6) |
aFatal AEs were as follows: gastrointestinal perforation (one in the placebo group); sudden death (one in RZV group); craniocerebral injury (one in RZV and one in placebo groups); hemorrhage intracranial (one in RZV group). No death was causally related to the vaccine, as assessed by the investigator and company.
bNo death was causally related to the vaccine, as assessed by the investigator and company.
Note: solicited AEs were ascertained only for participants who completed and returned the diary cards after any vaccination visit, whereas unsolicited AEs, medically attended AEs, SAEs, pIMDs, and deaths were assessed for all participants in the exposed set, independent of the status of the diary cards.
RZV group, participants receiving the adjuvanted recombinant zoster vaccine; placebo group, participants receiving placebo; n (%), number (percentage) of participants in each category; CI, confidence interval; N, total number of participants; AE, adverse event; SAE, serious adverse event; pIMD, potential immune-mediated disease.