Table 1.
Baseline Demographic Characteristics, Prior Vaccine Doses, and Seropositivity for the Randomized Population
| Characteristic | Infants by Vaccine Group, No. (%)a | |
|---|---|---|
| Rotarix (n = 128) | Placebo (n = 125) | |
| Male sex | 64 (50.0) | 67 (53.6) |
| Age, median (IQR), mo | 8.5 (6.9–10.3) | 8.7 (7.3–10.3) |
| Indigenous status | ||
| Aboriginal | 123 (96.1) | 121 (96.8) |
| Torres Strait Islander | 5 (3.9) | 2 (1.6) |
| Aboriginal and Torres Strait Islander | 0 (0) | 2 (1.6) |
| Usual location | ||
| Regional urban | 31 (24.2) | 33 (26.4) |
| Remote | 97 (75.8) | 92 (73.6) |
| Breastfed | ||
| Exclusively | 10 (7.8) | 8 (6.4) |
| Partially | 89 (69.5) | 97 (77.6) |
| Not breastfed | 29 (22.7) | 20 (16.0) |
| Weight, median (IQR), k | 8.5 (7.7–9·4) | 8.5 (7.8–9.1) |
| MUAC, median (IQR), mm | 145 (140–155) | 144 (140–155) |
| Preenrollment Rotarix doses | ||
| 1st Dose | 128 (100) | 125 (100) |
| Age at 1st dose, median (IQR), wk | 6.6 (6.2–7.1) | 6.7 (6.3–7.6) |
| 2nd Dose | 119 (93·0) | 122 (97·6) |
| Age at 2nd dose, median (IQR), wk | 17.9 (17.3–18.8) | 17.7 (17.4–18.4) |
| Seroresponse at baseline(IgA ≥20 AU/mL) | ||
| Yes | 83 (64.8) | 92 (73.6) |
| No | 37 (28.9) | 29 (23.2) |
| Missing | 8 (6.2) | 4 (3.2) |
| IgA concentration at baseline, median (IQR), AU/mL | 59.6 (17.8–151.0) | 93.1 (21.2–164.0) |
Abbreviations: AU, arbitrary units; IgA, immunoglobulin A; IQR, interquartile range; MUAC, mid-upper arm circumference.
Data represent no. (%) of infants unless otherwise specified.