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Table 5 Safety overview after each CYD-TDV dose – safety analysis set

From: Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults

  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)
  1. AE adverse event, AR adverse reaction, CI confidence interval, M number of participants evaluable for the specified endpoint, n number of participants with the specified event
  2. aFor CYD-TDV injection only; YF safety data not presented here