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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 0–6a
  All grades Grade 1 Grade 2 Grade 3
  TIV/AS03(≥65) (N = 69)
Injection site
Ecchymosisb 2.9 (0.4–10) 2.9 (0.4–10) 0.0 (0.0–5.2) 0.0 (0.0–5.2)
Painc 62 (50–74) 52 (40–64) 10 (4.2–20) 0.0 (0.0–5.2)
Rednessb 7.2 (2.4–16) 5.8 (1.6–14) 1.4 (0.0–7.8) 0.0 (0.0–5.2)
Swellingb 12 (5.1–22) 8.7 (3.3–18) 2.9 (0.4–10) 0.0 (0.0–5.2)
Systemic
Arthralgiacd 20 (12–32) 15 (7.2–25) 5.8 (1.6–14) 0.0 (0.0–5.2)
Fatiguecd 32 (21–44) 17 (9.3–28) 15 (7.2–25) 0.0 (0.0–5.2)
Gastrointestinalc 8.7 (3.3–18) 5.8 (1.6–14) 2.9 (0.4–10) 0.0 (0.0–5.2)
Headachec 32 (21–44) 23 (14–35) 8.7 (3.3–18) 0.0 (0.0–5.2)
Myalgiacd 25 (15–37) 17 (9.3–28) 7.2 (2.4–16) 0.0 (0.0–5.2)
Shiveringcd 16 (8.2–27) 12 (5.1–22) 4.3 (0.9–12) 0.0 (0.0–5.2)
Temperaturee 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
Ecchymosisb 1.4 (0.0–7.4) 1.4 (0.0–7.4) 0.0 (0.0–4.9) 0.0 (0.0–4.9)
Painc 21 (12–32) 18 (9.8–29) 2.7 (0.3–9.5) 0.0 (0.0–4.9)
Rednessb 0.0 (0.0–4.9) 0.0 (0.0–4.9) 0.0 (0.0–4.9) 0.0 (0.0–4.9)
Swellingb 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
Arthralgiacd 4.1 (0.9–12) 1.4 (0.0–7.4) 2.7 (0.3–9.5) 0.0 (0.0–4.9)
Fatiguecd 16 (8.8–27) 12 (5.8–22) 4.1 (0.9–12) 0.0 (0.0–4.9)
Gastrointestinalc 5.5 (1.5–13) 2.7 (0.3–9.5) 2.7 (0.3–9.5) 0.0 (0.0–4.9)
Headachec 9.6 (3.9–19) 8.2 (3.1–17) 1.4 (0.0–7.4) 0.0 (0.0–4.9)
Myalgiacd 11 (4.9–21) 9.6 (3.9–19) 1.4 (0.0–7.4) 0.0 (0.0–4.9)
Shiveringcd 0.0 (0.0–4.9) 0.0 (0.0–4.9) 0.0 (0.0–4.9) 0.0 (0.0–4.9)
Temperaturee 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
Ecchymosisb 0.0 (0.0–7.1) 0.0 (0.0–7.1) 0.0 (0.0–7.1) 0.0 (0.0–7.1)
Painc 70 (55–82) 46 (32–61) 24 (13–38) 0.0 (0.0–7.1)
Rednessb 0.0 (0.0–7.1) 0.0 (0.0–7.1) 0.0 (0.0–7.1) 0.0 (0.0–7.1)
Swellingb 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
Arthralgiacd 8.0 (2.2–19) 6.0 (1.3–17) 2.0 (0.1–11) 0.0 (0.0–7.1)
Fatiguecd 42 (28–57) 36 (23–51) 6.0 (1.3–17) 0.0 (0.0–7.1)
Gastrointestinalc 12 (4.5–24) 12 (4.5–24) 0.0 (0.0–7.1) 0.0 (0.0–7.1)
Headachec 28 (16–43) 22 (11–36) 6.0 (1.3–17) 0.0 (0.0–7.1)
Myalgiacd 22 (11–36) 18 (8.6–31) 4.0 (0.5–14) 0.0 (0.0–7.1)
Shiveringcd 4.0 (0.5–14) 2.0 (0.1–11) 0.0 (0.0–7.1) 2.0 (0.1–11)
Temperaturee 0.0 (0.0–7.1) 0.0 (0.0–7.1) 0.0 (0.0–7.1) 0.0 (0.0–7.1)
  1. aValues reported at two significant figures.
  2. bGrade 1, >20– ≤ 50 mm; Grade 2, >50– ≤ 100 mm; and Grade 3, >100 mm.
  3. 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).
  4. dSymptom was generalised/widespread.
  5. 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.
  6. CI, confidence interval; TIV, trivalent influenza vaccine; TIV/AS03, AS03-adjuvanted trivalent influenza vaccine.