Table 2.
Incidence of solicited local and general AEs reported during the 7‐day (days 0–6) post‐vaccination period overall per participant by frailty status (total vaccinated cohort diary card subset)
| Non‐frail, n (%) | Pre‐frail, n (%) | Frail, n (%) | Unknown, n (%) | |||||
|---|---|---|---|---|---|---|---|---|
| RZV group | Placebo group | RZV group | Placebo group | RZV group | Placebo group | RZV group | Placebo group | |
| Solicited local AEs | N = 2,007 | N = 2,034 | N = 1,977 | N = 1,964 | N = 489 | N = 468 | N = 21 | N = 17 |
| Pain | ||||||||
| All | 1,655 (82.5) | 209 (10.3) | 1,494 (75.6) | 211 (10.7) | 322 (65.8) | 51 (10.9) | 17 (81.0) | 1 (5.9) |
| Grade 3 | 115 (5.7) | 4 (0.2) | 125 (6.3) | 6 (0.3) | 38 (7.8) | 5 (1.1) | 1 (4.8) | 0 (0.0) |
| Redness (mm) | ||||||||
| All | 805 (40.1) | 25 (1.2) | 734 (37.1) | 28 (1.4) | 160 (32.7) | 2 (0.4) | 11 (52.4) | 0 (0.0) |
| >100 | 75 (3.7) | 0 (0.0) | 46 (2.3) | 0 (0.0) | 12 (2.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Swelling (mm) | ||||||||
| All | 545 (27.2) | 18 (0.9) | 497 (25.1) | 22 (1.1) | 107 (21.9) | 3 (0.6) | 6 (28.6) | 1 (5.9) |
| >100 | 24 (1.2) | 0 (0.0) | 19 (1.0) | 0 (0.0) | 2 (0.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Solicited general AEs | N = 2,007 | N = 2,034 | N = 1,971 | N = 1,964 | N = 488 | N = 468 | N = 21 | N = 18 |
|---|---|---|---|---|---|---|---|---|
| Fatigue | ||||||||
| All | 951 (47.4) | 301 (14·8) | 848 (43.0) | 339 (17.3) | 164 (33.6) | 96 (20.5) | 5 (23.8) | 4 (22.2) |
| Grade 3 | 114 (5.7) | 15 (0.7) | 93 (4.7) | 17 (0.9) | 22 (4.5) | 8 (1.7) | 0 (0.0) | 0 (0.0) |
| Gastrointestinal symptoms | ||||||||
| All | 369 (18.4) | 157 (7.7) | 325 (16.5) | 166 (8.5) | 65 (13.3) | 56 (12.0) | 2 (9.5) | 2 (11.1) |
| Grade 3 | 26 (1.3) | 11 (0.5) | 28 (1.4) | 8 (0.4) | 6 (1.2) | 5 (1.1) | 0 (0.0) | 0 (0.0) |
| Headache | ||||||||
| All | 838 (41.8) | 287 (14.1) | 676 (34.3) | 311 (15.8) | 147 (30.1) | 89 (19.0) | 6 (28.6) | 3 (16.7) |
| Grade 3 | 74 (3.7) | 8 (0.4) | 53 (2.7) | 12 (0.6) | 17 (3.5) | 10 (2.1) | 0 (0.0) | 0 (0.0) |
| Myalgia | ||||||||
| All | 952 (47.4) | 209 (10.3) | 828 (42.0) | 225 (11.5) | 173 (35.5) | 75 (16.0) | 5 (23.8) | 2 (11.1) |
| Grade 3 | 100 (5.0) | 8 (0.4) | 89 (4.5) | 8 (0.4) | 28 (5.7) | 12 (2.6) | 0 (0.0) | 0 (0.0) |
| Shivering | ||||||||
| All | 623 (31.0) | 111 (5.5) | 459 (23.3) | 107 (5.4) | 86 (17.6) | 41 (8.8) | 3 (14.3) | 3 (16.7) |
| Grade 3 | 103 (5.1) | 4 (0.2) | 57 (2.9) | 6 (0.3) | 18 (3.7) | 2 (0.4) | 0 (0.0) | 0 (0.0) |
| Temperature (°C) | ||||||||
| All | 465 (23.2) | 52 (2.6) | 368 (18.7) | 55 (2.8) | 70 (14.3) | 19 (4.1) | 1 (4.8) | 0 (0.0) |
| >39 | 6 (0.3) | 4 (0.2) | 5 (0.3) | 3 (0.2) | 2 (0.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Abbreviations: AE, adverse event; All, Grade > 0; N, number of participants in each group; n (%), number (percentage) of participants reporting the adverse event at least once; RZV, adjuvanted recombinant zoster vaccine.