Superior antigen-specific CD4+T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older

Couch, Robert B; Bayas, José M; Caso, Covadonga; Mbawuike, Innocent Nnadi; López, Concepción Núñez; Claeys, Carine; El Idrissi, Mohamed; Hervé, Caroline; Laupèze, Béatrice; Oostvogels, Lidia; Moris, Philippe

doi:10.1186/1471-2334-14-425

Table 5 Solicited injection site and systemic symptoms in response to vaccination

From: Superior antigen-specific CD4⁺T-cell response with AS03-adjuvantation of a trivalent influenza vaccine in a randomised trial of adults aged 65 and older

Solicited symptom	% of subjects (95% CI) reporting symptoms, Day 0–6^a
	All grades	Grade 1	Grade 2	Grade 3
	TIV/AS03(≥65) (N = 69)
*Injection site*
Ecchymosis^b	2.9 (0.4–10)	2.9 (0.4–10)	0.0 (0.0–5.2)	0.0 (0.0–5.2)
Pain^c	62 (50–74)	52 (40–64)	10 (4.2–20)	0.0 (0.0–5.2)
Redness^b	7.2 (2.4–16)	5.8 (1.6–14)	1.4 (0.0–7.8)	0.0 (0.0–5.2)
Swelling^b	12 (5.1–22)	8.7 (3.3–18)	2.9 (0.4–10)	0.0 (0.0–5.2)
*Systemic*
Arthralgia^cd	20 (12–32)	15 (7.2–25)	5.8 (1.6–14)	0.0 (0.0–5.2)
Fatigue^cd	32 (21–44)	17 (9.3–28)	15 (7.2–25)	0.0 (0.0–5.2)
Gastrointestinal^c	8.7 (3.3–18)	5.8 (1.6–14)	2.9 (0.4–10)	0.0 (0.0–5.2)
Headache^c	32 (21–44)	23 (14–35)	8.7 (3.3–18)	0.0 (0.0–5.2)
Myalgia^cd	25 (15–37)	17 (9.3–28)	7.2 (2.4–16)	0.0 (0.0–5.2)
Shivering^cd	16 (8.2–27)	12 (5.1–22)	4.3 (0.9–12)	0.0 (0.0–5.2)
Temperature^e	2.9 (0.4–10)	1.4 (0.0–7.8)	0.0 (0.0–5.2)	1.4 (0.0–7.8)
	TIV(≥65) (N = 73)
*Injection site*
Ecchymosis^b	1.4 (0.0–7.4)	1.4 (0.0–7.4)	0.0 (0.0–4.9)	0.0 (0.0–4.9)
Pain^c	21 (12–32)	18 (9.8–29)	2.7 (0.3–9.5)	0.0 (0.0–4.9)
Redness^b	0.0 (0.0–4.9)	0.0 (0.0–4.9)	0.0 (0.0–4.9)	0.0 (0.0–4.9)
Swelling^b	1.4 (0.0–7.4)	1.4 (0.0–7.4)	0.0 (0.0–4.9)	0.0 (0.0–4.9)
*Systemic*
Arthralgia^cd	4.1 (0.9–12)	1.4 (0.0–7.4)	2.7 (0.3–9.5)	0.0 (0.0–4.9)
Fatigue^cd	16 (8.8–27)	12 (5.8–22)	4.1 (0.9–12)	0.0 (0.0–4.9)
Gastrointestinal^c	5.5 (1.5–13)	2.7 (0.3–9.5)	2.7 (0.3–9.5)	0.0 (0.0–4.9)
Headache^c	9.6 (3.9–19)	8.2 (3.1–17)	1.4 (0.0–7.4)	0.0 (0.0–4.9)
Myalgia^cd	11 (4.9–21)	9.6 (3.9–19)	1.4 (0.0–7.4)	0.0 (0.0–4.9)
Shivering^cd	0.0 (0.0–4.9)	0.0 (0.0–4.9)	0.0 (0.0–4.9)	0.0 (0.0–4.9)
Temperature^e	0.0 (0.0–4.9)	0.0 (0.0–4.9)	0.0 (0.0–4.9)	0.0 (0.0–4.9)
	TIV(18-40) (N = 50)
*Injection site*
Ecchymosis^b	0.0 (0.0–7.1)	0.0 (0.0–7.1)	0.0 (0.0–7.1)	0.0 (0.0–7.1)
Pain^c	70 (55–82)	46 (32–61)	24 (13–38)	0.0 (0.0–7.1)
Redness^b	0.0 (0.0–7.1)	0.0 (0.0–7.1)	0.0 (0.0–7.1)	0.0 (0.0–7.1)
Swelling^b	0.0 (0.0–7.1)	0.0 (0.0–7.1)	0.0 (0.0–7.1)	0.0 (0.0–7.1)
*Systemic*
Arthralgia^cd	8.0 (2.2–19)	6.0 (1.3–17)	2.0 (0.1–11)	0.0 (0.0–7.1)
Fatigue^cd	42 (28–57)	36 (23–51)	6.0 (1.3–17)	0.0 (0.0–7.1)
Gastrointestinal^c	12 (4.5–24)	12 (4.5–24)	0.0 (0.0–7.1)	0.0 (0.0–7.1)
Headache^c	28 (16–43)	22 (11–36)	6.0 (1.3–17)	0.0 (0.0–7.1)
Myalgia^cd	22 (11–36)	18 (8.6–31)	4.0 (0.5–14)	0.0 (0.0–7.1)
Shivering^cd	4.0 (0.5–14)	2.0 (0.1–11)	0.0 (0.0–7.1)	2.0 (0.1–11)
Temperature^e	0.0 (0.0–7.1)	0.0 (0.0–7.1)	0.0 (0.0–7.1)	0.0 (0.0–7.1)

^aValues reported at two significant figures.
^bGrade 1, >20– ≤ 50 mm; Grade 2, >50– ≤ 100 mm; and Grade 3, >100 mm.
^cGrade 1, “easily tolerated” (“painful on touch” for injection site pain); Grade 2, “interferes with normal activity” (or “painful when limb is moved” for injection site pain); and Grade 3, “prevents normal activity” (or “considerable pain at rest” for injection site pain).
^dSymptom was generalised/widespread.
^eGrade 1, 38.0– < 38.5°C; Grade 2, 38.5– < 39.0°C; and Grade 3, 39.0– ≤ 40.0°C. No subjects reported temperature above 40°C.
CI, confidence interval; TIV, trivalent influenza vaccine; TIV/AS03, AS03-adjuvanted trivalent influenza vaccine.

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