Table 2.
RSV-associated hospitalizations and related efficacy endpoints in the open-label non-comparative studies
| Population | Study | RSV-associated hospitalization | RSV ICU admission | Mechanical ventilation | ||
|---|---|---|---|---|---|---|
| Incidence, n/N(%) | Total days/100 subjects | Days with increased supplemental oxygen | % Subjects | % Subjects | ||
| BPD/CLDP, prematurity, or CHD | Turti et al. [40] | 0/100 (0) | NA | NA | NA | NA |
| BPD/CLDP or prematurity | Expanded Access [32] | 12/565 (2.1) | NA | NA | NA | NA |
| BPD/CLDP | Lacaze-Masmonteil et al. [38] | First-season exposure: 1/71 (1.4) | NA | NA | NA | NA |
| Second-season exposure: 4/63 (6.3) | ||||||
| Prematurity | ||||||
| 29–32 weeks GA | PROTECT [39] | 5/285 (1.8) | 17.6 | Median 7.5 (range 6.0–9.0) | 0.7 | 0.7 |
| ≤35 weeks GA | Lacaze-Masmonteil et al. [38] | 5/134 (3.7) | NA | NA | NA | NA |
Detailed characteristics of these studies are presented in Appendix Table A1
BPD Bronchopulmonary dysplasia, CLDP chronic lung disease of prematurity, GA gestational age, ICU intensive care unit, NA not available, RSV respiratory syncytial virus