Table 1.
Demographics and baseline characteristics (intention-to-treat population)
| Placebo group (n=786) | Nirsevimab group (n=1564) | ||
|---|---|---|---|
| Age, months | |||
| Median (IQR) | 2·00 (0·99–3·71) | 2·02 (1·00–3·58) | |
| ≤3·0 | 531/786 (68%) | 1066/1564 (68%) | |
| >3·0 to ≤6·0 | 204/786 (26%) | 398/1564 (25%) | |
| >6·0 | 51/786 (6%) | 100/1564 (6%) | |
| Sex | |||
| Male | 389/786 (49%) | 828/1564 (53%) | |
| Female | 397/786 (51%) | 736/1564 (47%) | |
| Ancestry* | |||
| American Indian or Alaska Native | 26/786 (3%) | 57/1560 (4%) | |
| Asian | 24/786 (3%) | 39/1560 (3%) | |
| Black or African American | 176/786 (22%) | 406/1560 (26%) | |
| Native Hawaiian or other Pacific Islander | 8/786 (1%) | 12/1560 (1%) | |
| White | 478/786 (61%) | 919/1560 (59%) | |
| Other | 70/786 (9%) | 109/1560 (7%) | |
| Multiple categories | 4/786 (1%) | 18/1560 (1%) | |
| Hemisphere | |||
| Northern | 536/786 (68%) | 1086/1564 (69%) | |
| Southern | 250/786 (32%) | 478/1564 (31%) | |
| Weight on day 1, kg | |||
| Median (IQR) | 4·35 (3·00–6·00) | 4·40 (3·20–6·00) | |
| <5 | 482/786 (61%) | 973/1562 (62%) | |
| ≥5 | 304/786 (39%) | 589/1562 (38%) | |
| Gestational age, weeks | |||
| ≥29 to ≤32 | 116/786 (15%) | 219/1563 (14%) | |
| >32 to <35 | 175/786 (22%) | 344/1563 (22%) | |
| ≥35 to <37 | 76/786 (10%) | 139/1563 (9%) | |
| ≥37 | 419/786 (53%) | 861/1563 (55%) | |
| Multiple birth | 164/786 (21%) | 309/1563 (20%) | |
| Infants per trial | |||
| MELODY | 496/786 (63%) | 994/1564 (64%) | |
| Phase 2b† | 290/786 (37%) | 570/1564 (36%) | |
Data are median (IQR) or n/N (%), based on infants with available data. Data include infants who were dosed according to the proposed weight-banded dosing regimen only (ie, infants weighing <5 kg dosed with 50 mg, and those weighing ≥5 kg dosed with 100 mg).
Ancestry was reported by parents or guardians, and each category (except “multiple categories”) comprises infants for whom only that category was selected; “other” comprises infants whose parents or guardians indicated a category other than those listed, and “multiple categories” comprises those for whom more than one category was selected.
Includes only infants who weighed <5 kg at enrolment (ie, those who were treated in accordance with the proposed weight-banded regimen).