Table 3.
Participants reporting solicited local reactions and systemic adverse events after any dose with 7 days of vaccine or placebo, or any adverse events, unsolicited adverse events or serious adverse events in the 12-month reporting period in the safety seta.
| All participants |
9–17 years cohort |
18–26 years cohort |
27–45 years cohort |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | Vaccine | p value | Placebo | Vaccine | p value | Placebo | Vaccine | p value | Placebo | Vaccine | p value | |
| N = | 600 | 599 | 300 | 300 | 120 | 120 | 180 | 179 | ||||
| Any adverse event up to 12 months, n (%) | ||||||||||||
| 435 (72.5) | 418 (69.8) | .308 | 241 (80.3) | 227 (75.7) | .200 | 94 (78.3) | 91 (75.8) | .759 | 100 (55.6) | 100 (55.9) | 1.000 | |
| Local reactions, n (%)b | ||||||||||||
| Any | 80 (13.3) | 104 (17.4) | .055 | 51 (17.0) | 69 (23.0) | .083 | 16 (13.3) | 23 (19.2) | .294 | 13 (7.2) | 12 (6.7) | 1.000 |
| After dose 1 | 59 (9.8) | 61 (10.2) | 38 (12.7) | 40 (13.3) | 12 (10.0) | 14 (11.7) | 9 (5.0) | 7 (3.9) | ||||
| After dose 2 | 15 (2.6) | 36 (6.2) | 13 (4.4) | 24 (8.3) | 1 (0.9) | 8 (7.1) | 1 (0.6) | 4 (2.3) | ||||
| After dose 3 | 21 (3.7) | 41 (7.3) | 13 (4.5) | 31 (10.8) | 5 (4.9) | 8 (7.7) | 3 (1.8) | 2 (1.2) | ||||
| Systemic adverse events, n (%)b | ||||||||||||
| Any | 267 (44.5) | 248 (41.4) | .294 | 163 (54.3) | 148 (49.3) | .253 | 60 (50.0) | 49 (40.8) | .195 | 44 (24.4) | 51 (28.5) | .404 |
| After dose 1 | 161 (26.8) | 152 (25.4) | 99 (33.0) | 82 (27.3) | 39 (32.5) | 32 (26.7) | 23 (12.8) | 38 (21.2) | ||||
| After dose 2 | 117 (20.3) | 88 (15.2) | 78 (26.5) | 59 (20.3) | 24 (21.6) | 19 (17.0) | 15 (8.7) | 10 (5.7) | ||||
| After dose 3 | 97 (17.3) | 99 (17.7) | 64 (22.2) | 70 (24.5) | 17 (16.5) | 16 (15.4) | 16 (9.4) | 13 (7.6) | ||||
| Unsolicited adverse events up to 12 months, n (%) | ||||||||||||
| Any | 329 (54.8) | 314 (52.4) | .418 | 174 (58.0) | 169 (56.3) | .741 | 75 (62.5) | 68 (56.7) | .430 | 80 (44.4) | 77 (43.0) | .832 |
| Serious adverse events up to 12 months, n (%) | ||||||||||||
| Any | 5 (0.8) | 5 (0.8) | 1.000 | 2 (0.7) | 1 (0.3) | 1.000 | 1 (0.8) | 2 (1.7) | 1.000 | 2 (1.1) | 2 (1.1) | 1.000 |
aSafety Set includes all participants who received at least one dose of vaccine or placebo.
bSolicited local reactions and systemic adverse events were recorded during the 7 days after each vaccination.