Table 4.
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) |
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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.