Table 1. Baseline characteristics of the ITT population of HIV-infected participants.
Characteristic | R3R group N = 51 |
R3C group N = 54 |
C3C group N = 48 |
---|---|---|---|
Age category | |||
5–17 months, n (%) | 24 (47.1) | 29 (53.7) | 32 (66.7) |
6–12 weeks, n (%) | 27 (52.9) | 25 (46.3) | 16 (33.3) |
Mean age at dose 1±SD | |||
5–17 months, months | 10.3 ± 3.4 | 9.7 ± 4.0 | 10.8 ± 3.8 |
6–12 weeks, weeks | 7.6 ± 1.5 | 7.6 ± 1.6 | 7.5 ± 1.5 |
Mean age at HIV positive test ± SD | |||
5–17 months, months | 17.9 ± 7.5 | 22.4 ± 13.1 | 17.7 ± 12.3 |
6–12 weeks, months | 9.1 ± 7.8 | 10.0 ± 8.8 | 15.6 ± 9.9 |
Both age categories, months | 13.8 ± 8.8 | 17.1 ± 12.8 | 17.5 ± 11.6 |
Female sex, n (%) | 19 (37.3) | 34 (63.0) | 22 (45.8) |
Mean height-for-age z-score ± SD | —1.6 ± 1.1 | —1.7 ± 1.5a | —1.6 ± 1.3 |
Mean weight-for-age z-score ± SD | —1.1 ± 1.2b | —1.4 ± 1.4 | —1.1 ± 1.1 |
Mean Hb ± SD, g/dL | 10.2 ± 1.7 | 10.3 ± 1.6 | 10.2 ± 1.7 |
Moderate anemia c , n (%) | 4 (7.8) | 3 (5.6) | 2 (4.2) |
Study center, n (%) | |||
Agogo, Ghana | 2 (3.9) | 0 (0.0) | 1 (2.1) |
Bagamoyo, Tanzania | 2 (3.9) | 1 (1.9) | 1 (2.1) |
Kilifi, Kenya | 0 (0.0) | 2 (3.7) | 2 (4.2) |
Kintampo, Ghana | 0 (0.0) | 5 (9.3) | 3 (6.3) |
Kombewa, Kenya | 8 (15.7) | 5 (9.3) | 6 (12.5) |
Korogwe, Tanzania | 1 (2.0) | 2 (3.7) | 0 (0.0) |
Lambaréné, Gabon | 0 (0.0) | 0 (0.0) | 1 (2.1) |
Lilongwe, Malawi | 3 (5.9) | 9 (16.7) | 6 (12.5) |
Manhiça, Mozambique | 11 (21.6) | 12 (22.2) | 14(29.2) |
Nanoro, Burkina Faso | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Siaya, Kenya | 24 (47.1) | 18 (33.3) | 14(29.2) |
ITT, intent-to-treat; R3R, group receiving 4 doses of RTS,S/AS01; R3C, group receiving 3 doses of RTS,S/AS01 plus 1 dose of comparator vaccine; C3C, group receiving 4 doses of comparator vaccine; N, number of participants in the ITT population of HIV-infected participants; n (%), number (percentage) of participants in a given category; SD, standard deviation; Hb, hemoglobin.
Height-for-age z-score available for 52 participants in the R3C group.
Weight-for-age z-score available for 50 participants in the R3R group.
Hb < 8g/dL.