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. 2015 Feb 25;212(4):531–541. doi: 10.1093/infdis/jiv091

Table 4.

Global Summary of Adverse Events (AEs) Reported After Vaccination—Total Vaccinated Cohort

Follow up Period,a Outcome CC-3.75 µgHA + AS03A Recipients (n = 131)
CC-1.9 µgHA + AS03B Recipients (n = 80)
CC-15 µgPlainHA Recipients (n = 51)
Q-3.75 µgHA + AS03A Recipients (n = 80)
Q-15 µgPlainHA Recipients (n = 49)
Placebo (Saline) Recipients (n = 130)
No. Percentage (95% CI) No. Percentage (95% CI) No. Percentage (95% CI) No. Percentage (95% CI) No. Percentage (95% CI) No. Percentage (95% CI)
Day 42b
 Any unsolicited AE 44 33.6 (25.6–42.4) 21 26.3 (17.0–37.3) 15 29.4 (17.5–43.8) 16 20.0 (11.9–30.4) 15 30.6 (18.3–45.4) 35 26.9 (19.5–35.4)
 Any grade 3 unsolicited AE 7 5.3 (2.2–10.7) 3 3.8 (.8–10.6) 2 3.9 (.5–13.5) 2 2.5 (.3–8.7) 2 4.1 (.5–14.0) 3 2.3 (.5–6.6)
Month 12c
 Any medically attended AE 21 16.0 (10.2–23.5) 17 21.3 (12.9–31.8) 4 7.8 (2.2–18.9) 12 15.0 (8.0–24.7) 9 18.4 (8.8–32.0) 16 12.3 (7.2–19.2)
 Any pIMD 0 1 1.3 (.0–6.8) 0 0 0 0
 Any severe AE 3 2.3 (.5–6.5) 3 3.8 (.8–10.6) 0 2 2.5 (.3–8.7) 0 1 0.8 (.0–4.2)

Abbreviations: CC-1.9 µgHA + AS03B, cell-culture-derived formulation with 1.9 µg of HA plus AS03B adjuvant; CC-3.75 µgHA + AS03A, cell-culture-derived formulation with 3.75 µg of HA plus AS03A adjuvant; CC-15 µgPlainHA, cell-culture-derived formulation with 15 µg of HA without adjuvant; CI, confidence interval; HA, hemagglutinin antigen; pIMD, potential immune-mediated disease; Q-3.75 µgHA + AS03A, egg-derived formulation with 3.75 µg of HA plus AS03A adjuvant; Q-15 µgPlainHA, egg-derived formulation with 15 µg of HA without adjuvant.

a After receipt of the first dose of vaccine or placebo.

b 21 day follow-up after each vaccination.

c 12 months follow-up after vaccination schedule.