Table I. Baseline characteristics of 588 Mozambican children included in the study.
| Comparator vaccine (%) or [S.D.] | RTS,S vaccine (%) or [S.D.] | p valuea | < 2 years (%) | 2–4 years (%) | p value | Control (%) | Case (%) | p value | |
|---|---|---|---|---|---|---|---|---|---|
| Probed | 297 (51) | 291 (49) | 157 (27) | 431 (73) | 392 (67) | 196 (33) | |||
| Age group | |||||||||
| < 2 year | 79 (13) | 78 (13) | 0.96 | – | – | – | – | ||
| 2–4 year | 218 (37) | 213 (36) | – | – | – | – | |||
| Nested case-control | |||||||||
| Case | 111 (19) | 85 (14) | 0.04 | 66 (11) | 130 (22) | 0.01 | – | – | |
| Control | 186 (32) | 206 (35) | 91 (15) | 301 (51) | – | – | |||
| Bednet use at D0b | |||||||||
| Yes | 14 (2) | 10 (2) | 0.43 | 6 (1) | 18 (3) | 0.85 | 12 (2) | 12 (2) | 0.08 |
| No | 283 (48) | 281 (48) | 151 (26) | 413 (70) | 380 (65) | 184 (31) | |||
| Gender | |||||||||
| Female | 144 (24) | 127 (22) | 0.24 | 71 (12) | 200 (34) | 0.80 | 179 (30) | 92 (16) | 0.77 |
| Male | 153 (26) | 164 (28) | 86 (15) | 231 (39) | 213 (36) | 108 (18) | |||
| Previous clinical malaria | |||||||||
| 0 | 197 (34) | 210 (36) | 0.13 | 95 (16) | 312 (53) | 0.01 | 308 (52) | 99 (17) | <0.01 |
| ≥ 1 | 100 (17) | 81 (14) | 62 (11) | 119 (20) | 84 (14) | 97 (16) | |||
| Infection M8.5c | |||||||||
| Neg | 243 (41) | 257 (44) | 0.03 | 136 (23) | 364 (62) | 0.51 | 348 (59) | 152 (26) | <0.01 |
| Pos | 54 (9) | 34 (6) | 21 (4) | 67 (11) | 44 (7) | 44 (7) | |||
| Protein array print batch | |||||||||
| Accent A | 121 (21) | 129 (22) | 0.46 | 157 (27) | 93 (16) | <0.01 | 162 (28) | 88 (15) | 0.09 |
| Accent B | 168 (29) | 153 (26) | 0 (0) | 321 (55) | 214 (36) | 107 (18) | |||
| Omni100a | 6 (1) | 4 (1) | 0 (0) | 10 (2) | 10 (2) | 0 (0) | |||
| Omni100b | 2 (0.3) | 5 (1) | 0 (0) | 7 (1) | 6 (1) | 1 (0.2) | |||
| Protein array pad | |||||||||
| 1 | 34 (6) | 37 (6) | 0.01 | 21 (4) | 50 (9) | 0.99 | 45 (8) | 26 (4) | 0.68 |
| 2 | 33 (6) | 39 (7) | 20 (3) | 52 (9) | 54 (9) | 18 (3) | |||
| 3 | 34 (6) | 36 (6) | 19 (3) | 51 (9) | 46 (8) | 24 (4) | |||
| 4 | 27 (5) | 45 (8) | 19 (3) | 53 (9) | 49 (8) | 23 (4) | |||
| 5 | 32 (5) | 44 (7) | 20 (3) | 56 (10) | 45 (8) | 31 (5) | |||
| 6 | 42 (7) | 36 (6) | 20 (3) | 58 (10) | 52 (9) | 26 (4) | |||
| 7 | 50 (9) | 28 (5) | 20 (3) | 58 (10) | 54 (9) | 24 (4) | |||
| 8 | 45 (8) | 26 (4) | 18 (3) | 53 (9) | 47 (8) | 24 (4) | |||
| Distance to clinicd | |||||||||
| km | 1.7 [1.1] | 1.8 [1.0] | 0.14e | 1.7 [1.0] | 1.8 [1.1] | 0.41e | 1.7 [1.0] | 1.8 [1.2] | 0.36e |
| IFAT titer at screeningf | |||||||||
| GMT | 2712 [13.4] | 2029 [11.8] | 0.18g | 1046 [10.9] | 3147 [12.5] | <0.01g | 1750 [12.4] | 4220 [11.8] | <0.01g |
a Reported p values are chi-squared tests unless otherwise stated;
b Reported bednet use at the time that the first dose of RTS,S/AS02 or comparator vaccine was administered;
c Study month 8.5 corresponding to 6 months post-vaccination.
d Mean distance in km to nearest hospital or health care facility;
e Two-sample T-test;
f Immunofluorescence antibody test (IFAT) at screening is during visit before administration of first dose of vaccine, reported as geometric mean endpoint titer;
g Two-sample Wilcoxon rank-sum test.