Table 1.
Characteristics and Outcomes of Study Participants at Follow-up
| Placebo (n = 350) | SP (n = 380) | Pa | |
| Characteristics | |||
| Sex Male Female |
183 (52.3) 167 (47.7) |
192 (50.5) 188 (49.5) |
.64 |
| Age, months, mean ± SD | 53.1 ± 3.7 | 52.8 ± 3.8 | .37 |
| β-Globin genotypeb HbAA HbAS HbSS HbAC HbCC HbSC Missing data |
258 (73.7) 39 (11.1) 1 (.3) 34 (9.7) 1 (.3) 4 (1.1) 13 (3.7) |
275 (72.4) 44 (11.6) 1 (.3) 45 (11.8) 1 (.3) 4 (1.1) 10 (2.6) |
.96 |
| Absent at follow up Moved Withdrawn Lost to follow-up Died |
51 (57.3) 16 (18.0) 20 (22.5) 2 (2.3) |
38 (55.9) 14 (20.6) 13 (19.0) 3 (4.3) |
.82 |
| Outcomes | |||
| Uncomplicated malariac Yes No Missing data |
18 (5.1) 319 (91.1) 13 (3.7) |
27 (7.1) 337 (88.7) 16 (4.2) |
.50 |
| Parasitemia Positive Negative Missing data |
120 (34.3) 217 (62.0) 13 (3.7) |
126 (33.2) 238 (62.6) 16 (4.2) |
.91 |
| Total PfLIgG level, RUs, median (IQR) Missing data |
22.2 (9.3-38.5) 12 (3.4) |
19.1 (6.8-34.5) 9 (2.4) |
<.05 |
| Hb level, g/dL, mean ± SD | 10.3 ± 1.6 | 10.3 ± 1.5 | .77 |
| Anemia Moderate anemia (<7.5 g/dL) Severe anemia (<5.0 g/dL) |
10 (2.9) 0 |
11 (2.9) 2 (.5) |
.98 .39 |
| Outpatient visitsd Yes, many times Yes, sometimes Yes, once in a while No Missing data |
119 (34.0) 141 (40.3) 71 (20.3) 18 (5.1) 1 (.3) |
120 (31.6) 159 (41.8) 83 (21.8) 18 (4.7) 0 |
.77 |
| Hospital admissionsd No Yes, once Yes, more than once Yes, frequency unknown |
277 (79.1) 47 (13.4) 23 (6.6) 3 (.9) |
305 (80.3) 38 (10.0) 34 (9.0) 3 (.8) |
.36 |
NOTE. Data are no. (%) of participants, unless otherwise indicated. Hb, hemoglobin; IQR, interquartile range; PfLIgG, anti-Plasmodium falciparum lysate IgG antibody; RUs, relative units; SD, standard deviation; SP, sulfadoxine-pyrimethamine.
Determined using Wilcoxon rank-sum test or χ2 test. P values <.05 were considered significant.
β-Globin genotype was determined by polymerase chain reaction.
An episode of malaria was defined as fever (axillary temperature of ≥38.0°C or fever during the preceding 48 h reported by caretakers without being asked accompanied by asexual P. falciparum parasite load of >500/μL.
Frequencies since last follow-up of core study. Information obtained by interviewing participants’ mothers and caretakers and reviewing medical records.