drugset / Trial / NCT07158814
Safety of RSV Preventive Monoclonal Antibody
Phase 4
Recruiting
524 enrolled
Duke University
Centers for Disease Control and Prevention · collabChildren's Hospital Medical Center, Cincinnati · collabColumbia University · collabEmory University · collabKaiser Permanente · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other vaccines at separate visits (Visits 1 and 2).
Timeline
- Start
- 2025-10-02
- Primary completion
- 2027-02
- Completion
- 2027-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nirsevimab | Monoclonal antibody | — | — |
Indications
No indication recorded.