Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05437510 | Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life | PHASE3 | COMPLETED | 8,057 | — | — | Aug 8, 2022 | Apr 9, 2025 | Oct 9, 2025 | 240 | France, Germany +1 |
LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths per minute (/min); 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection.
| Arm | Type | Description |
|---|---|---|
| Nirsevimab | EXPERIMENTAL | 1 intramuscular injection at Day 01 |
| No preventive intervention for RSV | NO_INTERVENTION | No intervention |
| Name | Type | Description |
|---|---|---|
| Nirsevimab | BIOLOGICAL | Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular |
Inclusion Criteria: * Born at ≥ 29 weeks gestational age and aged 0 to 12 months (calendar age), who entered their first RSV season on the day of inclusion in the study (D01) * Informed consent form was signed and dated by the parent(s) or other LAR(s) (and by an independent witness if required by ...