Table 5 Safety overview after each CYD-TDV dose – safety analysis set
Group 1 (N = 120) | Group 2 (N = 120) | Group 3 (N = 119) | ||||
|---|---|---|---|---|---|---|
n/M | % (95% CI) | n/M | % (95% CI) | n/M | % (95% CI) | |
First CYD-TDV dose | ||||||
Solicited reaction | 75/118 | 63.6 (54.2–72.2) | 77/119 | 64.7 (55.4–73.2) | 87/115 | 75.7 (66.8–83.2) |
Solicited injection site reactiona | 34/118 | 28.8 (20.8–37.9) | 42/118 | 35.3 (26.8–44.6) | 40/115 | 34.8 (26.1–44.2) |
Solicited systemic reaction | 65/118 | 55.1 (45.7–64.3) | 68/118 | 57.1 (47.7–66.2) | 77/115 | 67.0 (57.6–75.4) |
Unsolicited non-serious AE | 34/120 | 28.3 (20.5–37.3) | 32/120 | 26.7 (19.0–35.5) | 27/119 | 22.7 (15.5–31.3) |
Unsolicited non-serious AR | 7/120 | 5.8 (2.4–11.6) | 4/120 | 3.3 (0.9–8.3) | 9/119 | 7.6 (3.5–13.9) |
Unsolicited non-serious injection site ARa | 4/120 | 3.3 (0.9–8.3) | 3/120 | 2.5 (0.5–7.1) | 0/119 | 0.0 (0.0–3.1) |
Unsolicited non-serious systemic AE | 31/120 | 25.8 (18.3–34.6) | 30/120 | 25.0 (17.5–33.7) | 25/119 | 21.0 (14.1–29.4) |
Unsolicited non-serious systemic AR | 3/120 | 2.5 (0.5–7.1) | 2/120 | 1.7 (0.2–5.9) | 7/119 | 5.9 (2.4–11.7) |
Second CYD-TDV dose | ||||||
Solicited reaction | 44/101 | 43.6 (33.7–53.8) | 57/114 | 50.0 (40.5–59.5) | 40/96 | 41.7 (31.7–52.2) |
Solicited injection site reaction | 21/101 | 20.8 (13.4–30.0) | 32/114 | 28.1 (20.1–37.3) | 24/96 | 25.0 (16.7–34.9) |
Solicited systemic reaction | 38/101 | 37.6 (28.2–47.8) | 43/114 | 37.7 (28.8–47.3) | 33/96 | 34.4 (25.0–44.8) |
Unsolicited non-serious AE | 15/105 | 14.3 (8.2–22.5) | 18/116 | 15.5 (9.5–23.4) | 15/108 | 13.9 (8.0–21.9) |
Unsolicited non-serious AR | 3/105 | 2.9 (0.6–8.1) | 2/116 | 1.7 (0.2–6.1) | 0/108 | 0.0 (0.0–3.4) |
Unsolicited non-serious injection site AR | 1/105 | 1.0 (0.0–5.2) | 1/116 | 0.9 (0.0–4.7) | 0/108 | 0.0 (0.0–3.4) |
Unsolicited non-serious systemic AE | 15/105 | 14.3 (8.2–22.5) | 18/116 | 15.5 (9.5–23.4) | 15/108 | 13.9 (8.0–21.9) |
Unsolicited non-serious systemic AR | 2/105 | 1.9 (0.2–6.7) | 1/116 | 0.9 (0.0–4.7) | 0/108 | 0.0 (0.0–3.4) |
Third CYD-TDV dose | ||||||
Solicited reaction | 36/91 | 39.6 (29.5–50.4) | 47/107 | 43.9 (34.3–53.9) | 37/89 | 41.6 (31.2–52.5) |
Solicited injection site reaction | 19/91 | 20.9 (13.1–30.7) | 29/106 | 27.4 (19.1–36.9) | 21/89 | 23.6 (15.2–33.8) |
Solicited systemic reaction | 32/91 | 35.2 (25.4–45.9) | 39/107 | 36.4 (27.4–46.3) | 32/89 | 36.0 (26.1–46.8) |
Unsolicited non-serious AE | 19/98 | 19.4 (12.1–28.6) | 17/110 | 15.5 (9.3–23.6) | 13/95 | 13.7 (7.5–22.3) |
Unsolicited non-serious AR | 2/98 | 2.0 (0.2–7.2) | 0/110 | 0.0 (0.0–3.3) | 1/95 | 1.1 (0.0–5.7) |
Unsolicited non-serious injection site AR | 2/98 | 2.0 (0.2–7.2) | 0/110 | 0.0 (0.0–3.3) | 0/95 | 0.0 (0.0–3.8) |
Unsolicited non-serious systemic AE | 17/98 | 17.3 (10.4–26.3) | 17/110 | 15.5 (9.3–23.6) | 13/95 | 13.7 (7.5–22.3) |
Unsolicited non-serious systemic AR | 0/98 | 0.0 (0.0–3.7) | 0/110 | 0.0 (0.0–3.3) | 1/95 | 1.1 (0.0–5.7) |