Table 4. Summary of solicited adverse reactions, unsolicited adverse events and serious adverse event in the safety analysis cohort.
| Reaction severity | Vaccine (n = 3629) | Placebo (n = 3631) | P value# | |||
|---|---|---|---|---|---|---|
| Batch 1 (n = 1199) | Batch 2 (n = 1230) | Batch 3 (n = 1200) | P value* | |||
| Solicited adverse reactions within 0–7 d | ||||||
| Any | 595, 49.6 (46.8–52.5) | 641, 52.1 (49.3–54.9) | 600, 50.0 (47.1–52.9) | 0.42 | 1786, 49.2 (47.6–50.8) | 0.23 |
| Grade 3 * | 30, 2.5 (1.7–3.6) | 17, 1.4 (0.8–2.3) | 28, 2.3 (1.6–3.4) | 0.11 | 59, 1.6 (1.3–2.1) | 0.16 |
| Injection-site adverse reactions | ||||||
| Any | 138, 11.5 (9.8–13.5) | 146, 11.9 (10.1–13.8) | 139, 11.6 (9.9–13.6) | 0.96 | 397, 10.9 (10.0–12.0) | 0.33 |
| Grade 3 | 3, 0.3 (0.1–0.8) | 0, 0.0 (0.0–0.4) | 2, 0.2 (0.0–0.7) | 0.18 | 3, 0.1 (0.0–0.3) | 0.51 |
| Systemic adverse reactions | ||||||
| Any | 534, 44.5 (41.7–47.4) | 578, 47.0 (44.2–49.8) | 539, 44.9 (42.1–47.8) | 0.42 | 1621, 44.6 (43.0–46.3) | 0.47 |
| Grade 3 | 27, 2.3 (1.5–3.3) | 17, 1.4 (0.8–2.3) | 26, 2.2 (1.5–3.2) | 0.23 | 56, 1.5 (1.2–2.0) | 0.21 |
| Unsolicited adverse events within 0–28 d | 591, 49.3 (46.4–52.2) | 635, 51.6 (48.8–54.5) | 576, 48.0 (45.1–50.9) | 0.19 | 1761, 48.5 (46.9–50.1) | 0.32 |
| Serious adverse events | 1, 0.1 (0.0–0.5) | 3, 0.2 (0.1–0.8) | 4, 0.3 (0.1–0.9) | 0.46 | 20, 0.6 (0.4–0.9) | 0.02 |
| Infections and infestations | 0, 0.0 (0.0–0.4) | 2, 0.2 (0.0–0.7) | 4, 0.3 (0.1–0.9) | 0.13 | 16, 0.4 (0.3–0.7) | 0.03 |
| Injury, poisoning, and procedural complications | 0, 0.0 (0.0–0.4) | 0, 0.0 (0.0–0.4) | 0, 0.0 (0.0–0.4) | - | 3, 0.1 (0.0–0.3) | 0.25 |
| General disorders and administration site conditions | 0, 0.0 (0.0–0.4) | 0, 0.0 (0.0–0.4) | 0, 0.0 (0.0–0.4) | - | 1, 0.0 (0.0–0.2) | 1.00 |
| Cardiac disorders | 1, 0.1 (0.0–0.5) | 0, 0.0 (0.0–0.4) | 0, 0.0 (0.0–0.4) | 0.33 | 0, 0.0 (0.0–0.1) | 0.50 |
| Gastrointestinal disorders | 0, 0.0 (0.0–0.4) | 1, 0.1 (0.0–0.5) | 0, 0.0 (0.0–0.4) | 1.00 | 0, 0.0 (0.0–0.1) | 0.50 |
Data are n, % (95% CI). n, number of subjects; Any, all the subjects with certain adverse reactions. *Grade 3 events were severe (i.e., prevented activity). *The P values were calculated for the comparison among the 3 batches of EV71 vaccines. #The P values were calculated for the comparison between the pooled EV71 vaccine group and the placebo group.