Table 1 Demographic and clinical characteristics of the whole study population
RTS,S/AS01E (n = 706) | Comparator (n = 322) | p value | |
|---|---|---|---|
Age at baseline, median (IQR) (weeks) | 25 (7, 45) | 27 (8, 46) | 0.36 |
Age category, n (%), infants (vs children) | 290 (41) | 119 (37) | 0.21 |
Site, n (%) | 0.45 | ||
Bagamoyo | 180 (25) | 92 (29) | |
Kintampo | 221 (31) | 90 (28) | |
Nanoro | 305 (43) | 140 (43) | |
Sex, n (%), male | 365 (52) | 144 (45) | 0.044 |
Weight, mean ± SD (kg) | 6.5 ± 1.9 | 6.6 ± 1.9 | 0.56 |
Weight-for-age Z-score, mean ± SD | −0.95 ± 1.21 | −0.96 ± 1.23 | 0.94 |
Height, median (IQR) (cm) | 65 (54, 70) | 65 (55, 70) | 0.56 |
Length/height-for-age Z-score, mean ± SD | −1.32 ± 1.37 | −1.32 ± 1.30 | 1.00 |
Number of clinical malaria episodes between pre- (M0) and post- (M3) vaccination, n (%) | 174 (25) | 97 (30) | 0.07 |
1 episode | 157 (22) | 79 (25) | |
2 or more episodes | 17 (2) | 18 (5) | |
Seasonality of transmission at the post-vaccination time point, n (%) | 0.215 | ||
High | 390 (55) | 162 (50) | |
Low or no transmission | 316 (45) | 160 (50) | |
Anaemiaa, n (%) | 0.25 | ||
No anaemia | 142 (20) | 71 (22) | |
Mild | 180 (25) | 67 (21) | |
Moderate or severe | 384 (54) | 184 (57) | |
Baseline haemoglobin level, mean ± SD (g dL−1) | 9.74 ± 1.64 | 9.62 ± 1.74 | 0.28 |
Parasitaemia for subjects who had a first clinical malaria episode between M3 + 14 days and M15, Geometric mean ± SD | 20,417 ± 18 | 22,387 ± 17 | 0.90 |