Table 4.
Safety overview after vaccine injection (SafAS)
| MenACYW-TT (N = 506) | MCV4-TT (N = 408) | ||||
|---|---|---|---|---|---|
| Participants experiencing at least one: | Maximum intensity (grade) | n/N | % (95% CI) | n/N | % (95% CI) |
| Within 30 min after vaccine injection | |||||
| Immediate unsolicited AE | Any | 0/506 | 0.0 (0.0–0.7) | 0/408 | 0.0 (0.0–0.9) |
| Immediate unsolicited AR | Any | 0/506 | 0.0 (0.0–0.7) | 0/408 | 0.0 (0.0–0.9) |
| Within 7 days after vaccination | |||||
| Solicited injection site reaction | Any | 261/506 | 51.6 (47.1–56.0) | 214/407 | 52.6 (47.6–57.5) |
| Grade 3 | 20/506 | 4.0 (2.4–6.0) | 12/407 | 2.9 (1.5–5.1) | |
| Tenderness | Any | 177/506 | 35.0 (30.8–39.3) | 133/407 | 32.7 (28.1–37.5) |
| Grade 3 | 2/506 | 0.4 (0.0–1.4) | 5/407 | 1.2 (0.4–2.8) | |
| Erythema | Any | 174/506 | 34.4 (30.3–38.7) | 136/407 | 33.4 (28.8–38.2) |
| Grade 3 | 17/506 | 3.4 (2.0–5.3) | 7/407 | 1.7 (0.7–3.5) | |
| Swelling | Any | 98/506 | 19.4 (16.0–23.1) | 61/407 | 15.0 (11.7–18.8) |
| Grade 3 | 9/506 | 1.8 (0.8–3.3) | 2/407 | 0.5 (0.1–1.8) | |
| Solicited systemic reaction | Any | 318/506 | 62.8 (58.5–67.1) | 237/407 | 58.2 (53.3–63.1) |
| Grade 3 | 23/506 | 4.5 (2.9–6.7) | 15/407 | 3.7 (2.1–6.0) | |
| Fever | Any | 52/506 | 10.3 (7.8–13.3) | 49/405 | 12.1 (9.1–15.7) |
| Grade 3 | 5/506 | 1.0 (0.3–2.3) | 3/405 | 0.7 (0.2–2.1) | |
| Vomiting | Any | 40/506 | 7.9 (5.7–10.6) | 20/407 | 4.9 (3.0–7.5) |
| Grade 3 | 1/506 | 0.2 (0.0–1.1) | 0/407 | 0.0 (0.0–0.9) | |
| Abnormal crying | Any | 154/506 | 30.4 (26.5–34.6) | 133/407 | 32.7 (28.1–37.5) |
| Grade 3 | 7/506 | 1.4 (0.6–2.8) | 7/407 | 1.7 (0.7–3.5) | |
| Drowsiness | Any | 115/506 | 22.7 (19.1–26.6) | 74/407 | 18.2 (14.6–22.3) |
| Grade 3 | 4/506 | 0.8 (0.2–2.0) | 0/407 | 0.0 (0.0–0.9) | |
| Appetite loss | Any | 146/506 | 28.9 (24.9–33.0) | 121/407 | 29.7 (25.3–34.4) |
| Grade 3 | 6/506 | 1.2 (0.4–2.6) | 2/407 | 0.5 (0.1–1.8) | |
| Irritability | Any | 220/506 | 43.5 (39.1–47.9) | 163/407 | 40.0 (35.3–45.0) |
| Grade 3 | 6/506 | 1.2 (0.4–2.6) | 6/407 | 1.5 (0.5–3.2) | |
| Within 30 days after vaccination | |||||
| Unsolicited AE | Any | 270/506 | 53.4 (48.9–57.8) | 204/408 | 50.0 (45.0, 55.0) |
| Unsolicited AR | Any | 16/506 | 3.2 (1.8–5.1) | 14/408 | 3.4 (1.9, 5.7) |
| AE leading to study discontinuation | Any | 0/506 | 0.0 (0.0–0.7) | 0/408 | 0.0 (0.0, 0.9) |
| During the study | |||||
| SAE | Any | 4/506 | 0.8 (0.2–2.0) | 3/408 | 0.7 (0.2–2.1) |
| AESI | Any | 2/506 | 0.4 (0.0–1.4) | 0/408 | 0.0 (0.0–0.9) |
| Death | Any | 0/506 | 0.0 (0.0–0.7) | 0/408 | 0.0 (0.0–0.9) |
AE, adverse event; n, number of participants who reported an AE; N, number of participants in the safety analysis set.