Table 1.
Demographic characteristics.
| All ages (6 through 71 months)* |
6 to through 11 months** |
12 through 35 months** |
36 through 71 months** |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Population | TIV | aTIV | placebo | TIV | aTIV | placebo | TIV | aTIV | placebo | TIV | aTIV | placebo |
| N | 119 | 118 | 59 | 26 | 30 | 12 | 34 | 31 | 14 | 33 | 38 | 17 |
| Gender, n (%) | ||||||||||||
| Male | 59 (49.6) | 63 (53.4) | 30 (50.8) | 11 (42.3) | 18 (60.0) | 5 (41.7) | 15 (44.1) | 16 (51.6) | 5 (35.7) | 20 (60.6) | 20 (52.6) | 11 (64.7) |
| Female | 60 (50.4) | 55 (46.6) | 29 (49.2) | 15 (57.7) | 12 (40.0) | 7 (58.3) | 19 (55.9) | 15 (48.4) | 9 (64.3) | 13 (39.4) | 18 (47.4) | 6 (35.3) |
| Age (months) | ||||||||||||
| Mean (SD) | 27.4 (18.8) | 29.4 (20.7) | 28.5 (18.3) | 8.0 (1.6) | 8.1 (1.7) | 8.6 (1.7) | 23.5 (6.3) | 24.0 (6.7) | 25.1 (6.5) | 50.7 (10.5) | 55.4 (9.7) | 49.5 (8.5) |
| Range | 6.0–69.0 | 6.0–70.0 | 6.0–70.0 | 6.0–11.0 | 6.0–11.0 | 6.0–11.0 | 15.0–35.0 | 15.0–34.0 | 14.0–33.0 | 37.0–69.0 | 38.0–70.0 | 38.0–68.0 |
| Ethnicity, n(%) | ||||||||||||
| Sérère | 116 (97.5) | 115 (97.5) | 55 (93.2) | 26 (100.0) | 28 (93.3) | 11 (91.7) | 34 (100.0) | 31 (100.0) | 13 (92.9) | 32 (97.0) | 37 (97.4) | 16 (94.1) |
| Other | 3 (2.5) | 3 (2.5) | 4 (6.8) | 0 (0.0) | 2 (6.7) | 1 (8.3) | 0 (0.0) | 0 (0.0) | 1 (7.1) | 1 (3.0) | 1 (2.6) | 1 (5.9) |
| Underweight*** | ||||||||||||
| None | 96 (80.7) | 92 (78.0) | 47 (79.7) | 21 (80.8) | 24 (80.0) | 10 (83.3) | 27 (79.4) | 23 (74.2) | 12 (85.7) | 25 (75.8) | 28 (73.7) | 13 (76.5) |
| Mild | 17 (14.3) | 20 (17.0) | 10 (17.0) | 5 (19.2) | 3 (10.0) | 1 (8.3) | 5 (14.7) | 5 (16.1) | 2 (14.3) | 5 (15.2) | 10 (26.3) | 4 (23.5) |
| Moderate | 4 (3.4) | 6 (5.1) | 2 (3.4) | 0 (0.0) | 3 (10.0) | 1 (8.3) | 2 (5.9) | 3 (9.7) | 0 (0.0) | 1 (3.0) | 0 (0.0) | 0 (0.0) |
| Severe | 2 (1.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (6.1) | 0 (0.0) | 0 (0.0) |
| None | 58 (48.7) | 57 (48.3) | 29 (49.2) | 8 (30.8) | 11 (36.7) | 3 (25.0) | 18 (52.9) | 12 (38.7) | 7 (50.0) | 23 (69.7) | 26 (68.4) | 11 (64.7) |
| Mild | 30 (25.2) | 31 (26.3) | 13 (22.0) | 8 (30.8) | 6 (20.0) | 3 (25.0) | 6 (17.7) | 11 (35.5) | 1 (7.1) | 6 (18.2) | 9 (23.7) | 5 (29.4) |
| Moderate | 20 (16.8) | 20 (17.0) | 11 (18.6) | 6 (23.1) | 7 (23.3) | 5 (41.7) | 7 (20.6) | 5 (16.1) | 3 (21.4) | 3 (9.1) | 3 (7.9) | 1 (5.9) |
| Stunting*** | ||||||||||||
| Severe | 11 (9.2) | 10 (8.5) | 6 (10.2) | 4 (15.4) | 6 (20.0) | 1 (8.3) | 3 (8.8) | 3 (9.7) | 3 (21.4) | 1 (3.0) | 0 (0.0) | 0 (0.0) |
*
Baseline demographic characteristics for all randomized subjects.
**
Demographic characteristics of those included in per-protocol analyses of immunogenicity.
***
Underweight (weight for age) and stunting (height for age) categories based on Z-scores, Mild (—2 to <—1), Moderate (−3 to <—2) or Severe (<—3). Z scores calculated using WHO Child Growth Standards, WHO STATA igrowup package and WHO STATA 2007 package.