Table 1.
Demographics and other baseline characteristics of subjects in cohorts 1, 2, 3 and 4 (enrolled population, excluding non-compliant site)
| Cohort 1 (9–17 years) | Cohort 2 (3–8 years) | ||||||
|---|---|---|---|---|---|---|---|
| 3.75 μg +halfMF59 (n = 80 ) | 7.5 μg +fullMF59 (n = 79 ) | Total (n = 159 ) | 3.75 μg +halfMF59 (n = 72 ) | 7.5 μg +fullMF59 (n = 73 ) | 15 μg +noMF59 (n = 39 ) | Total (n = 184 ) | |
| Age (years), mean ± SD | 13.2±2.7 | 13.2±2.7 | 13.2±2.7 | 5.5±1.9 | 5.3±1.7 | 5.2±1.5 | 5.3±1.7 |
| Age (months), mean ± SD | 166.9±32.7 | 167.5±31.4 | 167.2±32.0 | 71.6±24.7 | 69.6±21.6 | 68.4±20.1 | 70.1±22.5 |
| Sex, n (%) | |||||||
| Male | 39 (49) | 42 (53) | 81 (51) | 27 (38) | 42 (58) | 14 (36) | 83 (45) |
| Female | 41 (51) | 37 (47) | 78 (49) | 45 (63) | 31 (42) | 25 (64) | 101 (55) |
| Ethnic origin, n (%) | |||||||
| Asian | 2 (3) | 0 | 2 (1) | 0 | 1 (1) | 1 (3) | 2 (1) |
| Black | 0 | 0 | 0 | 3 (4) | 2 (3) | 0 | 5 (3) |
| Caucasian | 77 (96) | 79 (100) | 156 (98) | 64 (89) | 70 (96) | 34 (87) | 168 (91) |
| Hispanic | 0 | 0 | 0 | 2 (3) | 0 | 0 | 2 (1) |
| Other | 1 (1) | 0 | 1 (<1) | 3 (4) | 0 | 4 (10) | 7 (4) |
| Height (cm), mean ± SD | 158.8±16.0 | 159.8±15.6 | 159.3±15.7 | 116.8±13.5 | 114.8±11.5 | 113.0±11.4 | 115.2±12.3 |
| Weight (kg), mean ± SD | 51.4±15.7 | 52.5±16.2 | 51.9±15.9 | 22.1±6.5 | 21.6±5.3 | 21.1±5.9 | 21.7±5.9 |
| Body mass index (kg/m2), mean ± SD | 19.9±3.3 | 20.2±4.6 | 20.0±4.0 | 16.0±3.0 | 16.1±1.7 | 16.2±2.1 | 16.1±2.4 |
| Previous influenza vaccination, n (%) | 14 (18) | 22 (28) | 36 (23) | 18 (25) | 16 (22) | 8 (21) | 42 (23) |
| Cohort 3 (1–<3 years) | Cohort 4 (6–11 months) | ||||||
| 3.75 μg +halfMF59 (n = 66 ) | 7.5 μg +fullMF59 (n = 71 ) | 15 μg +noMF59 (n = 35 ) | Total (n = 172 ) | 3.75 μg +halfMF59 (n = 75 ) | 7.5 μg +fullMF59 (n = 76 ) | Total (n = 151) | |
| Age (months), mean ± SD | 21.8±7.3 | 23.1±7.1 | 23.1±7.8 | 22.6±7.3 | 8.9±1.5 | 8.8 ±1.7 | 8.9±1.6 |
| Sex, n (%) | |||||||
| Male | 32 (48) | 46 (65) | 20 (57) | 98 (57) | 35 (47) | 34 (45) | 69 (46) |
| Female | 34 (52) | 25 (35) | 15 (43) | 74 (43) | 40 (53) | 42 (55) | 82 (54) |
| Ethnic origin, n (%) | |||||||
| Asian | 2 (3) | 2 (3) | 2 (6) | 6 (3) | 0 | 0 | 0 |
| Black | 2 (3) | 1 (1) | 1 (3) | 4 (2) | 0 | 3 (4) | 3 (2) |
| Caucasian | 37 (56) | 42 (59) | 19 (54) | 98 (57) | 12 (16) | 10 (13) | 22 (15) |
| Hispanic | 24 (36) | 25 (35) | 13 (37) | 62 (36) | 63 (84) | 62 (82) | 125 (83) |
| Other | 1 (2) | 1 (1) | 0 | 2 (1) | 0 | 1 (1) | 1 (<1 ) |
| Height (cm), mean ± SD | 83.9±7.0 | 85.7±7.8 | 85.0±7.2 | 84.9±7.4 | 71.4±4.8 | 71.4±4.0 | 71.4±4.4 |
| Weight (kg), mean ± SD | 12.5±2.4 | 13.0±2.6 | 12.0±2.1 | 12.6±2.4 | 9.1±1.3 | 9.1±1.4 | 9.1±1.4 |
| Body mass index (kg/m2), mean ± SD | 17.7±2.6 | 17.8±3.1 | 16.7±2.2 | 17.5±2.7 | 18.0±2.4 | 17.9±2.5 | 17.9±2.4 |
| Previous influenza vaccination, n (%) | 5 (8) | 5 (7) | 3 (9) | 13 (8) | 0 | 0 | 0 |
SD, standard deviation