Table 6. Demographic characteristics, prior seasonal influenza vaccine, and study site, by study group.
Post 1st dose administration | Post 2nd dose administration | |||||||
---|---|---|---|---|---|---|---|---|
STUDY GROUP | AEs | Participants | AE per participant | AEs | Participants | AE per participant | ||
n o | with AE (n o ) | Median | (P 25 -P 75 ) | n o | with AE (n o ) | Median | (P 25 -P 75 ) | |
Group 1A: 15μg H7N9 + IB160 | 135 | 47 | 2 | (1–4) | 83 | 39 | 2 | (1–3) |
Group 1B: 7.5μg H7N9 + IB160 | 134 | 43 | 2 | (1–4) | 105 | 39 | 2 | (2–4) |
Group 1C: 3.75μg H7N9 + IB160 | 111 | 46 | 2 | (1–3) | 113 | 37 | 3 | (1–4) |
Group 2A: 15μg H7N9 + SE | 94 | 37 | 2 | (1–4) | 58 | 28 | 2 | (1–3) |
Group 2B: 7.5μg H7N9 + SE | 108 | 46 | 2 | (1–3) | 91 | 33 | 2 | (1–3) |
Group 2C: 3.75μg H7N9 + SE | 95 | 37 | 2 | (1–3) | 91 | 36 | 2 | (1–3) |
Group 3: 15μg H7N9 without adjuvant | 86 | 33 | 2 | (1–4) | 59 | 26 | 2 | (1–3) |
Group 4: Placebo | 88 | 37 | 2 | (1–3) | 39 | 21 | 2 | (1–2) |
TOTAL | 851 | 326 | 2 | (1–3) | 639 | 259 | 2 | (1–3) |
STUDY GROUP | ARs | Participants | AR per participant | ARs | Participants | AR per participant | ||
n o | with AR (n o ) | Median | (P 25 -P 75 ) | n o | with AR (n o ) | Median | (P 25 -P 75 ) | |
Group 1A: 15μg H7N9 + IB160 | 120 | 47 | 2 | (1–3) | 71 | 38 | 1 | (1–2) |
Group 1B: 7.5μg H7N9 + IB160 | 122 | 41 | 2 | (1–4) | 86 | 37 | 2 | (1–3) |
Group 1C: 3.75μg H7N9 + IB160 | 95 | 45 | 2 | (1–3) | 95 | 36 | 2 | (1–3.5) |
Group 2A: 15μg H7N9 + SE | 82 | 35 | 2 | (1–3) | 49 | 25 | 2 | (1–3) |
Group 2B: 7.5μg H7N9 + SE | 94 | 43 | 1 | (1–2) | 76 | 28 | 2 | (1–3) |
Group 2C: 3.75μg H7N9 + SE | 81 | 33 | 2 | (1–3) | 70 | 32 | 1.5 | (1–2.5) |
Group 3: 15μg H7N9 without adjuvant | 72 | 31 | 2 | (1–3) | 43 | 23 | 2 | (1–2) |
Group 4: Placebo | 68 | 33 | 2 | (1–3) | 30 | 15 | 2 | (1–3) |
TOTAL | 734 | 308 | 2 | (1–3) | 520 | 234 | 2 | (1–3) |
adj: adjuvant; P25: first quartile; P75: third quartile